Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-01 @ 8:11 PM
Study NCT ID:
NCT02731820
Status:
COMPLETED
Last Update Posted:
2019-11-12
First Post:
2016-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Potassium Citrate in the Treatment of Postmenopausal Osteopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019357', 'term': 'Potassium Citrate'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002119', 'term': 'Calcium Carbonate'}], 'ancestors': [{'id': 'D019343', 'term': 'Citric Acid'}, {'id': 'D002951', 'term': 'Citrates'}, {'id': 'D014233', 'term': 'Tricarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ctc@ior.it', 'phone': '+39 051.6366392', 'title': 'Director of Clinical Trials', 'organization': 'Istituto Ortopedico Rizzoli'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded at 3 months and 6 months', 'description': 'Gastrointestinal disorders', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group', 'description': 'Potassium citrate Calcium carbonate Vitamin D3\n\nPotassium citrate: Kcitr 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)\n\nVitamin D3: 400 IU/die Vitamin D3 daily by mouth\n\nCalcium carbonate: 500 mg/die calcium carbonate daily by mouth', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group, Placebo', 'description': 'Placebo (Excipients) Calcium carbonate Vitamin D3\n\nPlacebo: Excipients: 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)\n\nVitamin D3: 400 IU/die Vitamin D3 daily by mouth\n\nCalcium carbonate: 500 mg/die calcium carbonate daily by mouth', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Serum Level of Carboxyterminal Cross-linked Telopeptide of Type I Collagen (CTX); Over Time, i.e. Baseline, 3 Months, 6 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group, Potassium Citrate', 'description': 'Potassium citrate Calcium carbonate Vitamin D3\n\nPotassium citrate: Kcitr 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)\n\nVitamin D3: 400 IU/die Vitamin D3 daily by mouth\n\nCalcium carbonate: 500 mg/die calcium carbonate daily by mouth'}, {'id': 'OG001', 'title': 'Control Group, Placebo', 'description': 'Placebo (Excipients) Calcium carbonate Vitamin D3\n\nPlacebo: Excipients: 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)\n\nVitamin D3: 400 IU/die Vitamin D3 daily by mouth\n\nCalcium carbonate: 500 mg/die calcium carbonate daily by mouth'}], 'classes': [{'title': 'Baseline (T0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': '3 months (T3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': '6 months (T6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.172', 'groupIds': ['OG000'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.027', 'groupIds': ['OG000'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.053', 'groupIds': ['OG000'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.002', 'groupIds': ['OG001'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.006', 'groupIds': ['OG001'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.139', 'groupIds': ['OG001'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.967', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.446', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.869', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (T0), 3 months (T3) 6 months (T6)', 'description': "Carboxyterminal cross-linked telopeptide of type I collagen (CTX) is a degradation product of the type I collagen; it is considered as a marker of bone resorption. The concentration of CTX (µg/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol.\n\nAt the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).\n\nDifferences will be considered to be statistically significant for p-value \\<0.05.", 'unitOfMeasure': 'µg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '3/20 patients in the Treatment group did not complete the follow up (n= 1 re-evaluation of the inclusion criteria; n=1 gastritis; n=1 total hip arthroplasty).\n\n2/20 patients in the Placebo group did not complete the follow up (n=2 persistent constipation)'}, {'type': 'PRIMARY', 'title': 'Changes in Serum Levels of "Tartrate-resistant Acid Phosphatase 5b Isoenzyme" (TRAcP5b) Over Time, i.e. Baseline, 3 Months, 6 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group, Potassium Citrate', 'description': 'Potassium citrate Calcium carbonate Vitamin D3\n\nPotassium citrate: Kcitr 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)\n\nVitamin D3: 400 IU/die Vitamin D3 daily by mouth\n\nCalcium carbonate: 500 mg/die calcium carbonate daily by mouth'}, {'id': 'OG001', 'title': 'Control Group, Placebo', 'description': 'Placebo (Excipients) Calcium carbonate Vitamin D3\n\nPlacebo: Excipients: 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)\n\nVitamin D3: 400 IU/die Vitamin D3 daily by mouth\n\nCalcium carbonate: 500 mg/die calcium carbonate daily by mouth'}], 'classes': [{'title': 'Baseline (T0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.35', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '2.64', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': '3 months (T3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.79', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '2.85', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': '6 months (T6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.69', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '2.25', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.954', 'groupIds': ['OG000'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.798', 'groupIds': ['OG000'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.377', 'groupIds': ['OG000'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.886', 'groupIds': ['OG001'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.040', 'groupIds': ['OG001'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.017', 'groupIds': ['OG001'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.343', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.859', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.172', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (T0), 3 months (T3) 6 months (T6)', 'description': 'Tartrate-resistant acid phosphatase 5b isoenzyme" (TRAcP5b) is a specific product of osteoclasts; it is considered as a marker of bone resorption. The concentration of TRAcP5B (U/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer\'s protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium Citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).\n\nDifferences will be considered to be statistically significant for p-value \\<0.05.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '3/20 patients in the Treatment group did not complete the follow up (n= 1 re-evaluation of the inclusion criteria; n=1 gastritis; n=1 total hip arthroplasty).\n\n2/20 patients in the Placebo group did not complete the follow up (n=2 persistent constipation)'}, {'type': 'PRIMARY', 'title': 'Changes in Serum Levels of "N-terminal Propeptide of Type I Procollagen" (P1NP) Over Time, i.e. Baseline, 3 Months, 6 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group, Potassium Citrate', 'description': 'Potassium citrate Calcium carbonate Vitamin D3\n\nPotassium citrate: Kcitr 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)\n\nVitamin D3: 400 IU/die Vitamin D3 daily by mouth\n\nCalcium carbonate: 500 mg/die calcium carbonate daily by mouth'}, {'id': 'OG001', 'title': 'Control Group, Placebo', 'description': 'Placebo (Excipients) Calcium carbonate Vitamin D3\n\nPlacebo: Excipients: 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)\n\nVitamin D3: 400 IU/die Vitamin D3 daily by mouth\n\nCalcium carbonate: 500 mg/die calcium carbonate daily by mouth'}], 'classes': [{'title': 'Baseline (T0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.45', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '18.82', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': '3 months (T3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.24', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '18.39', 'spread': '1.75', 'groupId': 'OG001'}]}]}, {'title': '6 months (T6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.97', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '16.77', 'spread': '1.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.213', 'groupIds': ['OG000'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.191', 'groupIds': ['OG000'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.234', 'groupIds': ['OG000'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.370', 'groupIds': ['OG001'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.176', 'groupIds': ['OG001'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.139', 'groupIds': ['OG001'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.551', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.371', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.466', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (T0), 3 months (T3) 6 months (T6)', 'description': 'N-terminal propeptide of type I procollagen" (P1NP) is a product of the conversion of procollagen to collagen; it is considered as a marker of bone formation. The concentration of P1NP (pg/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer\'s protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).\n\nDifferences will be considered to be statistically significant for p-value \\<0.05.', 'unitOfMeasure': 'pg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '3/20 patients in the Treatment group did not complete the follow up (n= 1 re-evaluation of the inclusion criteria; n=1 gastritis; n=1 total hip arthroplasty).\n\n2/20 patients in the Placebo group did not complete the follow up (n=2 persistent constipation)'}, {'type': 'PRIMARY', 'title': 'Changes in Serum Levels of "Bone-specific Alkaline Phosphatase" (BAP) Over Time, i.e. Baseline, 3 Months, 6 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group, Potassium Citrate', 'description': 'Potassium citrate Calcium carbonate Vitamin D3\n\nPotassium citrate: Kcitr 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)\n\nVitamin D3: 400 IU/die Vitamin D3 daily by mouth\n\nCalcium carbonate: 500 mg/die calcium carbonate daily by mouth'}, {'id': 'OG001', 'title': 'Control Group, Placebo', 'description': 'Placebo (Excipients) Calcium carbonate Vitamin D3\n\nPlacebo: Excipients: 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)\n\nVitamin D3: 400 IU/die Vitamin D3 daily by mouth\n\nCalcium carbonate: 500 mg/die calcium carbonate daily by mouth'}], 'classes': [{'title': 'Baseline (T0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.89', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '20.36', 'spread': '1.17', 'groupId': 'OG001'}]}]}, {'title': '3 months (T3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.81', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '18.27', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': '6 months (T6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.83', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '15.79', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.094', 'groupIds': ['OG000'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0004', 'groupIds': ['OG000'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.008', 'groupIds': ['OG000'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.002', 'groupIds': ['OG001'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0007', 'groupIds': ['OG001'], 'groupDescription': 'Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.458', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.434', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.555', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (T0), 3 months (T3) 6 months (T6)', 'description': "Bone-specific alkaline phosphatase (BAP) is a specific product of osteoblasts; it is considered as a marker of bone formation. The concentration of BAP (µg/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).\n\nDifferences will be considered to be statistically significant for p-value \\<0.05.", 'unitOfMeasure': 'µg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '3/20 patients in the Treatment group did not complete the follow up (n= 1 re-evaluation of the inclusion criteria; n=1 gastritis; n=1 total hip arthroplasty).\n\n2/20 patients in the Placebo group did not complete the follow up (n=2 persistent constipation)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group, Potassium Citrate', 'description': 'Potassium citrate Calcium carbonate Vitamin D3\n\nPotassium citrate: Kcitr 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)\n\nVitamin D3: 400 IU/die Vitamin D3 daily by mouth\n\nCalcium carbonate: 500 mg/die calcium carbonate daily by mouth'}, {'id': 'FG001', 'title': 'Control Group, Placebo', 'description': 'Placebo (Excipients) Calcium carbonate Vitamin D3\n\nPlacebo: Excipients: 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)\n\nVitamin D3: 400 IU/die Vitamin D3 daily by mouth\n\nCalcium carbonate: 500 mg/die calcium carbonate daily by mouth'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited among the cohort of post-menopausal women attending to the Radiodiagnostic Unit of Istituto Ortopedico Rizzoli (IOR) from September 2015 to February 2017 to perform the periodic measurements of lumbar (at L2-L4 level) and femoral bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group, Potassium Citrate', 'description': 'Potassium citrate Calcium carbonate Vitamin D3\n\nPotassium citrate: Kcitr 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)\n\nVitamin D3: 400 IU/die Vitamin D3 daily by mouth\n\nCalcium carbonate: 500 mg/die calcium carbonate daily by mouth'}, {'id': 'BG001', 'title': 'Control Group, Placebo', 'description': 'Placebo (Excipients) Calcium carbonate Vitamin D3\n\nPlacebo: Excipients: 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)\n\nVitamin D3: 400 IU/die Vitamin D3 daily by mouth\n\nCalcium carbonate: 500 mg/die calcium carbonate daily by mouth'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.8', 'spread': '4.67', 'groupId': 'BG000'}, {'value': '58.2', 'spread': '4.95', 'groupId': 'BG001'}, {'value': '59.5', 'spread': '4.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Osteopenic post-menopausal women', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '23.6', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '22.9', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '23.3', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'T score (BMD femural neck)', 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '-1.7', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '-1.6', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'T-score shows how much bone mineral density (BMD) is higher or lower than the bone density of a healthy 30-year old adult.\n\nAccording to the World Health Organization (WHO):\n\n* T-score of -1.0 or above= normal bone density;\n* T-score between -1.0 and -2.5 means = osteopenia;\n* T-score of -2.5 or below = osteoporosis.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'T score (L2 - L4)', 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '-1.4', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '-1.6', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'T-score shows how much bone mineral density (BMD) is higher or lower than the bone density of a healthy 30-year old adult.\n\nAccording to the World Health Organization (WHO):\n\n* T-score of -1.0 or above= normal bone density;\n* T-score between -1.0 and -2.5 means = osteopenia;\n* T-score of -2.5 or below = osteoporosis.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Major osteoporotic risk', 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '4.8', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '5.2', 'spread': '2.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Ten-year percentage probability of a major osteoporotic fracture (spine, forearm, hip or shoulder fracture) calculated according to "Fracture risk assessment tool (FRAX™)" (available on www.sheffield.ac.uk/FRAX/tool.aspx?lang=en).', 'unitOfMeasure': '% (percentage probability)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Minor osteoporotic risk', 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '1.0', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '1.0', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Ten-year percentage probability of hip fracture calculated according to "Fracture risk assessment tool (FRAX™)" (available on www.sheffield.ac.uk/FRAX/tool.aspx?lang=en).', 'unitOfMeasure': '% (percentage probability)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'pH (24h urine)', 'classes': [{'categories': [{'measurements': [{'value': '6.13', 'groupId': 'BG000', 'lowerLimit': '5.28', 'upperLimit': '7.00'}, {'value': '6.03', 'groupId': 'BG001', 'lowerLimit': '4.65', 'upperLimit': '7.14'}, {'value': '6.08', 'groupId': 'BG002', 'lowerLimit': '4.65', 'upperLimit': '7.14'}]}]}], 'paramType': 'MEAN', 'description': 'Reference value: 5.50 - 7.00', 'unitOfMeasure': 'pH value', 'dispersionType': 'FULL_RANGE'}, {'title': 'pH (fasting-morning urine)', 'classes': [{'categories': [{'measurements': [{'value': '6.13', 'groupId': 'BG000', 'lowerLimit': '4.97', 'upperLimit': '7.36'}, {'value': '5.87', 'groupId': 'BG001', 'lowerLimit': '4.59', 'upperLimit': '7.05'}, {'value': '6.00', 'groupId': 'BG002', 'lowerLimit': '4.59', 'upperLimit': '7.36'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: Reference value 5.50 - 7.00', 'unitOfMeasure': 'pH value', 'dispersionType': 'FULL_RANGE'}, {'title': 'Potassium (24h urine)', 'classes': [{'categories': [{'measurements': [{'value': '28.60', 'spread': '14.97', 'groupId': 'BG000'}, {'value': '30.40', 'spread': '12.98', 'groupId': 'BG001'}, {'value': '29.50', 'spread': '13.85', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Reference value: 50-100 mEq day-1', 'unitOfMeasure': 'milliequivalent day-1', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Citrate (24h urine)', 'classes': [{'categories': [{'measurements': [{'value': '2.97', 'spread': '1.68', 'groupId': 'BG000'}, {'value': '3.50', 'spread': '1.74', 'groupId': 'BG001'}, {'value': '3.24', 'spread': '1.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Reference value: \\>3.3 mmol day-1', 'unitOfMeasure': 'mmol day-1', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Citrate (fasting-morning urine)', 'classes': [{'categories': [{'measurements': [{'value': '2.77', 'spread': '1.39', 'groupId': 'BG000'}, {'value': '3.40', 'spread': '2.39', 'groupId': 'BG001'}, {'value': '3.09', 'spread': '1.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Reference value: \\> 0.3 mol mol-1 (Citrate/Creatinine)', 'unitOfMeasure': 'mol mol-1', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-09', 'size': 754988, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-01-31T12:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2016-03-31', 'resultsFirstSubmitDate': '2019-02-01', 'studyFirstSubmitQcDate': '2016-04-07', 'lastUpdatePostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-21', 'studyFirstPostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Serum Level of Carboxyterminal Cross-linked Telopeptide of Type I Collagen (CTX); Over Time, i.e. Baseline, 3 Months, 6 Months.', 'timeFrame': 'Baseline (T0), 3 months (T3) 6 months (T6)', 'description': "Carboxyterminal cross-linked telopeptide of type I collagen (CTX) is a degradation product of the type I collagen; it is considered as a marker of bone resorption. The concentration of CTX (µg/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol.\n\nAt the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).\n\nDifferences will be considered to be statistically significant for p-value \\<0.05."}, {'measure': 'Changes in Serum Levels of "Tartrate-resistant Acid Phosphatase 5b Isoenzyme" (TRAcP5b) Over Time, i.e. Baseline, 3 Months, 6 Months.', 'timeFrame': 'Baseline (T0), 3 months (T3) 6 months (T6)', 'description': 'Tartrate-resistant acid phosphatase 5b isoenzyme" (TRAcP5b) is a specific product of osteoclasts; it is considered as a marker of bone resorption. The concentration of TRAcP5B (U/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer\'s protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium Citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).\n\nDifferences will be considered to be statistically significant for p-value \\<0.05.'}, {'measure': 'Changes in Serum Levels of "N-terminal Propeptide of Type I Procollagen" (P1NP) Over Time, i.e. Baseline, 3 Months, 6 Months.', 'timeFrame': 'Baseline (T0), 3 months (T3) 6 months (T6)', 'description': 'N-terminal propeptide of type I procollagen" (P1NP) is a product of the conversion of procollagen to collagen; it is considered as a marker of bone formation. The concentration of P1NP (pg/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer\'s protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).\n\nDifferences will be considered to be statistically significant for p-value \\<0.05.'}, {'measure': 'Changes in Serum Levels of "Bone-specific Alkaline Phosphatase" (BAP) Over Time, i.e. Baseline, 3 Months, 6 Months.', 'timeFrame': 'Baseline (T0), 3 months (T3) 6 months (T6)', 'description': "Bone-specific alkaline phosphatase (BAP) is a specific product of osteoblasts; it is considered as a marker of bone formation. The concentration of BAP (µg/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).\n\nDifferences will be considered to be statistically significant for p-value \\<0.05."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['potassium citrate'], 'conditions': ['Osteopenia', 'Bone Disease, Metabolic']}, 'referencesModule': {'references': [{'pmid': '20655868', 'type': 'BACKGROUND', 'citation': 'Arnett TR. Acidosis, hypoxia and bone. Arch Biochem Biophys. 2010 Nov 1;503(1):103-9. doi: 10.1016/j.abb.2010.07.021. Epub 2010 Jul 23.'}, {'pmid': '25572045', 'type': 'BACKGROUND', 'citation': 'Lambert H, Frassetto L, Moore JB, Torgerson D, Gannon R, Burckhardt P, Lanham-New S. The effect of supplementation with alkaline potassium salts on bone metabolism: a meta-analysis. Osteoporos Int. 2015 Apr;26(4):1311-8. doi: 10.1007/s00198-014-3006-9. Epub 2015 Jan 9.'}, {'pmid': '24094472', 'type': 'BACKGROUND', 'citation': 'Hanley DA, Whiting SJ. Does a high dietary acid content cause bone loss, and can bone loss be prevented with an alkaline diet? J Clin Densitom. 2013 Oct-Dec;16(4):420-5. doi: 10.1016/j.jocd.2013.08.014. Epub 2013 Oct 2.'}, {'pmid': '23162100', 'type': 'BACKGROUND', 'citation': 'Jehle S, Hulter HN, Krapf R. Effect of potassium citrate on bone density, microarchitecture, and fracture risk in healthy older adults without osteoporosis: a randomized controlled trial. J Clin Endocrinol Metab. 2013 Jan;98(1):207-17. doi: 10.1210/jc.2012-3099. Epub 2012 Nov 15.'}, {'pmid': '30213095', 'type': 'RESULT', 'citation': 'Granchi D, Caudarella R, Ripamonti C, Spinnato P, Bazzocchi A, Massa A, Baldini N. Potassium Citrate Supplementation Decreases the Biochemical Markers of Bone Loss in a Group of Osteopenic Women: The Results of a Randomized, Double-Blind, Placebo-Controlled Pilot Study. Nutrients. 2018 Sep 12;10(9):1293. doi: 10.3390/nu10091293.'}], 'seeAlsoLinks': [{'url': 'http://www.ior.it/', 'label': 'Istituto Ortopedico Rizzoli\\_Home Page'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether the use of alkali compounds, i.e. potassium citrate (K3C6H5O7, hereinafter KCitr) is effective in preventing the progression of osteopenia.\n\nA randomized clinical trial (RCT, placebo-controlled, double-blind) has been planned to evaluate the effect of the daily administration of KCitr (3 g/die, K 30 mEq).\n\nThe efficacy will be evaluated by comparing the circulating levels of bone turnover markers at the baseline and after the treatment (3, 6 months).', 'detailedDescription': 'Bone tissue carries out some of the important metabolic functions, including the regulation of acid-base balance. In order to buffer the systemic acidosis, the skeleton acts as a "ion exchange column" modifying the composition of the mineral portion, i.e. the hydroxyapatite. There is a linear correlation between elimination of calcium and acidosis: the higher is the acidosis, the higher will be the loss of calcium from bones. In vitro experiments showed that acidosis also directly influences the cellular component of bone by increasing the osteoclast activity and inhibiting the production of the mineralized matrix by osteoblast. Since the low pH is a risk factor that accelerates the bone loss, the use of alkalizing compounds could prevent the osteopenia or support the conventional therapy of the osteoporosis.\n\nKCitr is an alkaline compound which may be used in metabolic acidosis. Potassium is an alkaline metal that plays a pivotal role in the function of all living cells. Citric acid is a key molecule of the Krebs cycle, and it is abundant in bone where exhibits a stabilizing function. Although clinical data regarding the KCitr effectiveness on calcium metabolism are encouraging, it is still unclear whether the beneficial effects are due exclusively to the buffering function or whether KCitr may affect the bone cells activity. The purpose of this study is to evaluate the effects of KCitr on bone metabolism. We hypothesize that administration of potassium citrate to postmenopausal women with osteopenia will delay (or will prevent) the weakening of bone mass.\n\nPostmenopausal women with osteopenia (T score between -1.0 and -2.5) and no history of fracture will be randomized to assume KCitr ate or placebo, daily for six months. Primary outcomes will be evaluated by measuring markers of bone turnover, which will be measured at baseline (before treatment), in the mid-term (3 months) and at the end (6 months).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women, more than 5 years post menopause\n* Osteopenia (T-score \\< -1 and \\> -2.5)\n* Low risk of fracture (FRAX: \\< 20 major osteoporotic; \\< 3 hip fracture)\n\nExclusion Criteria:\n\n* Hyperkalemia\n* Renal insufficiency\n* Nephrolithiasis\n* Use of potassium sparing diuretics\n* Use of potassium supplements\n* Use of therapies influencing bone metabolism (e.g. corticosteroids, thiazide diuretics, aromatase inhibitors, estrogens)\n* Use of protonic pump inhibitors\n* Current or recent use of bisphosphonates (stopped less than three years prior to the start of the study)\n* Gastrointestinal disorders that hamper nutrient absorption;\n* Mental or psychiatric disorders that preclude the possibility of correctly adhering to the protocol'}, 'identificationModule': {'nctId': 'NCT02731820', 'acronym': 'ACAROS', 'briefTitle': 'Efficacy of Potassium Citrate in the Treatment of Postmenopausal Osteopenia', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Efficacy of Potassium Citrate in the Treatment of Postmenopausal Osteopenia. A Randomized, Placebo-controlled, Double Blind Investigation.', 'orgStudyIdInfo': {'id': '6013_IOR'}, 'secondaryIdInfos': [{'id': '1676', 'type': 'OTHER', 'domain': 'Istituto Ortopedico Rizzoli'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Potassium citrate Calcium carbonate Vitamin D3', 'interventionNames': ['Dietary Supplement: Potassium citrate', 'Dietary Supplement: Vitamin D3', 'Dietary Supplement: Calcium carbonate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group, Placebo', 'description': 'Placebo (Excipients) Calcium carbonate Vitamin D3', 'interventionNames': ['Dietary Supplement: Placebo', 'Dietary Supplement: Vitamin D3', 'Dietary Supplement: Calcium carbonate']}], 'interventions': [{'name': 'Potassium citrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Kcitr 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)', 'armGroupLabels': ['Treatment group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Excipients: 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)', 'armGroupLabels': ['Control group, Placebo']}, {'name': 'Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Cholecalciferol'], 'description': '400 IU/die Vitamin D3 daily by mouth', 'armGroupLabels': ['Control group, Placebo', 'Treatment group']}, {'name': 'Calcium carbonate', 'type': 'DIETARY_SUPPLEMENT', 'description': '500 mg/die calcium carbonate daily by mouth', 'armGroupLabels': ['Control group, Placebo', 'Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Nicola Baldini, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Ortopedico Rizzoli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All the results will be available "on request"'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Professor', 'investigatorFullName': 'Nicola Baldini', 'investigatorAffiliation': 'Istituto Ortopedico Rizzoli'}}}}