Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT00001304
Status:
COMPLETED
Last Update Posted:
2015-12-15
First Post:
1999-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007011', 'term': 'Hypoparathyroidism'}], 'ancestors': [{'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002117', 'term': 'Calcitriol'}, {'id': 'D002118', 'term': 'Calcium'}], 'ancestors': [{'id': 'D004100', 'term': 'Dihydroxycholecalciferols'}, {'id': 'D006887', 'term': 'Hydroxycholecalciferols'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'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': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'winerk@mail.nih.gov', 'phone': '+1 301 435 6877', 'title': 'WINER, Karen', 'organization': 'National Institute of Child Health and Human Development'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study reported here was the primary long-term study for adults with hypoparathyroidism. Subsequent studies included additional patients.'}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'PTH 1-34', 'description': 'All patients received twice daily synthetic Human Parathyroid Hormone 1-34.\n\nPTH 1-34', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Calcitriol & Calcium', 'description': 'All patients received twice daily Calcitriol and Calcium 1000mg divided into four doses daily.\n\nCalcitriol \\& Calcium', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Serum 1,25-hydroxyvitamin D Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol and Calcium', 'description': 'Twice daily po calcitriol with calcium carbonate given 4 times daily'}, {'id': 'OG001', 'title': 'PTH 1-34', 'description': 'PTH 1-34 given as 2 subcutaneous injections daily'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '5', 'groupId': 'OG000'}, {'value': '43', 'spread': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = pg/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients on the study'}, {'type': 'SECONDARY', 'title': 'Serum 25-hydroxyvitamin D Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol and Calcium', 'description': 'Twice daily po calcitriol with calcium carbonate given 4 times daily'}, {'id': 'OG001', 'title': 'PTH 1-34', 'description': 'PTH 1-34 given as 2 subcutaneous injections daily'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '5', 'groupId': 'OG000'}, {'value': '28', 'spread': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ng/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients on the study'}, {'type': 'PRIMARY', 'title': 'Serum Calcium Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol and Calcium', 'description': 'Twice daily po calcitriol with calcium carbonate given 4 times daily'}, {'id': 'OG001', 'title': 'PTH 1-34', 'description': 'PTH 1-34 given as 2 subcutaneous injections daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 2.05-2.5. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.', 'unitOfMeasure': 'mmol/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients on the study'}, {'type': 'SECONDARY', 'title': 'Serum Magnesium Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol and Calcium', 'description': 'Twice daily po calcitriol with calcium carbonate given 4 times daily'}, {'id': 'OG001', 'title': 'PTH 1-34', 'description': 'PTH 1-34 given as 2 subcutaneous injections daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.65-1.05. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.', 'unitOfMeasure': 'mmol/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients on the study'}, {'type': 'SECONDARY', 'title': 'Serum Phosphorus Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol and Calcium', 'description': 'Twice daily po calcitriol with calcium carbonate given 4 times daily'}, {'id': 'OG001', 'title': 'PTH 1-34', 'description': 'PTH 1-34 given as 2 subcutaneous injections daily'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.7-1.4. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.', 'unitOfMeasure': 'mmol/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients on the study'}, {'type': 'SECONDARY', 'title': 'Urinary Creatinine Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol and Calcium', 'description': 'Twice daily po calcitriol with calcium carbonate given 4 times daily'}, {'id': 'OG001', 'title': 'PTH 1-34', 'description': 'PTH 1-34 given as 2 subcutaneous injections daily'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'spread': '13', 'groupId': 'OG000'}, {'value': '80', 'spread': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ml/min, normal range 90-125. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.', 'unitOfMeasure': 'ml/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients on the study'}, {'type': 'PRIMARY', 'title': 'Urine Calcium Excretion Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol and Calcium', 'description': 'Twice daily po calcitriol with calcium carbonate given 4 times daily'}, {'id': 'OG001', 'title': 'PTH 1-34', 'description': 'PTH 1-34 given as 2 subcutaneous injections daily'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Measurements were taken1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/24 h, normal range 1.25-6.25. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.', 'unitOfMeasure': 'mmol/24 h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients on the study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Calcitriol and Calcium', 'description': 'Twice daily po calcitriol with calcium carbonate given 4 times daily'}, {'id': 'FG001', 'title': 'PTH 1-34', 'description': 'PTH 1-34 given as 2 subcutaneous injections daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Calcitriol and Calcium', 'description': 'Twice daily po calcitriol with calcium carbonate given 4 times daily'}, {'id': 'BG001', 'title': 'PTH 1-34', 'description': 'PTH 1-34 given as 2 subcutaneous injections daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', '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 (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': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1991-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-10', 'studyFirstSubmitDate': '1999-11-03', 'resultsFirstSubmitDate': '2015-03-12', 'studyFirstSubmitQcDate': '1999-11-03', 'lastUpdatePostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-10', 'studyFirstPostDateStruct': {'date': '1999-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Calcium Level', 'timeFrame': '3 years', 'description': 'Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 2.05-2.5. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.'}, {'measure': 'Urine Calcium Excretion Level', 'timeFrame': '3 years', 'description': 'Measurements were taken1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/24 h, normal range 1.25-6.25. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.'}], 'secondaryOutcomes': [{'measure': 'Serum 1,25-hydroxyvitamin D Level', 'timeFrame': '3 years', 'description': 'Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = pg/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.'}, {'measure': 'Serum 25-hydroxyvitamin D Level', 'timeFrame': '3 years', 'description': 'Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ng/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.'}, {'measure': 'Serum Magnesium Level', 'timeFrame': '3 years', 'description': 'Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.65-1.05. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.'}, {'measure': 'Serum Phosphorus Level', 'timeFrame': '3 years', 'description': 'Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.7-1.4. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.'}, {'measure': 'Urinary Creatinine Clearance', 'timeFrame': '3 years', 'description': 'Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ml/min, normal range 90-125. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypoparathyroidism', 'Parathyroid Hormone', 'Vitamin D', 'Calcium Metabolism', 'PTH 1-34', 'Bone'], 'conditions': ['Hypoparathyroidism']}, 'referencesModule': {'references': [{'pmid': '8773636', 'type': 'BACKGROUND', 'citation': 'Winer KK, Yanovski JA, Cutler GB Jr. Synthetic human parathyroid hormone 1-34 vs calcitriol and calcium in the treatment of hypoparathyroidism. JAMA. 1996 Aug 28;276(8):631-6.'}, {'pmid': '9768650', 'type': 'BACKGROUND', 'citation': 'Winer KK, Yanovski JA, Sarani B, Cutler GB Jr. A randomized, cross-over trial of once-daily versus twice-daily parathyroid hormone 1-34 in treatment of hypoparathyroidism. J Clin Endocrinol Metab. 1998 Oct;83(10):3480-6. doi: 10.1210/jcem.83.10.5185.'}, {'pmid': '22090268', 'type': 'BACKGROUND', 'citation': 'Winer KK, Zhang B, Shrader JA, Peterson D, Smith M, Albert PS, Cutler GB Jr. Synthetic human parathyroid hormone 1-34 replacement therapy: a randomized crossover trial comparing pump versus injections in the treatment of chronic hypoparathyroidism. J Clin Endocrinol Metab. 2012 Feb;97(2):391-9. doi: 10.1210/jc.2011-1908. Epub 2011 Nov 16.'}, {'pmid': '12970289', 'type': 'BACKGROUND', 'citation': 'Winer KK, Ko CW, Reynolds JC, Dowdy K, Keil M, Peterson D, Gerber LH, McGarvey C, Cutler GB Jr. Long-term treatment of hypoparathyroidism: a randomized controlled study comparing parathyroid hormone-(1-34) versus calcitriol and calcium. J Clin Endocrinol Metab. 2003 Sep;88(9):4214-20. doi: 10.1210/jc.2002-021736.'}, {'pmid': '18492754', 'type': 'BACKGROUND', 'citation': 'Winer KK, Sinaii N, Peterson D, Sainz B Jr, Cutler GB Jr. Effects of once versus twice-daily parathyroid hormone 1-34 therapy in children with hypoparathyroidism. J Clin Endocrinol Metab. 2008 Sep;93(9):3389-95. doi: 10.1210/jc.2007-2552. Epub 2008 May 20.'}]}, 'descriptionModule': {'briefSummary': 'This study has been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. Providing synthetic human parathyroid hormone 1-34 (PTH) to patients who are unresponsive to conventional therapy has enabled severe cases of hypoparathyroidism to be managed effectively with the investigational drug, PTH. The primary goals of this study are to (1) provide long-term PTH therapy to patients who do not respond to conventional therapy; (2) understand the long-term effect of therapeutic PTH replacement on kidney function and bone mineral density; (3) study and track linear growth and bone accrual in children with hypoparathyroidism. (4) determine if subjects reach a normal level of peak bone mass and if the timing of this is comparable to normal age-matched healthy controls.', 'detailedDescription': 'Vitamin D and its analogs, the conventional treatment for hypoparathyroidism, are associated with chronic hypercalciuria due to their lack of calcium-retaining effect in the kidney. This side effect usually occurs even while maintaining the serum calcium in the normal range and may lead to calcium deposition in the kidney (nephrocalcinosis) and renal insufficiency. This study examines the long-term effects of subcutaneous parathyroid hormone (PTH) therapy on calcium metabolism, bone, and renal function. Our previous short-term pilot study comparing subcutaneous PTH with calcitriol demonstrated a significant decrease in urinary calcium excretion during PTH therapy. Based upon these results, we hypothesized that treatment with PTH is more physiologic and provides improved long-term metabolic control. Additionally, treatment with PTH may avoid the adverse side effects on the kidney that are associated with conventional therapy. Patients initially come to the Clinical Center for a two week inpatient evaluation. Subsequent follow-up will occur semiannually on an outpatient basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nThis study will include patients (ages 17-69) with biochemically confirmed hypoparathyroidism.\n\nEXCLUSION CRITERIA\n\nWomen who are pregnant will be excluded.'}, 'identificationModule': {'nctId': 'NCT00001304', 'briefTitle': 'Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34', 'orgStudyIdInfo': {'id': '920011'}, 'secondaryIdInfos': [{'id': '92-CH-0011', 'type': 'OTHER_GRANT', 'domain': 'NIH Clinical Center_NICHD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PTH 1-34', 'description': 'All patients received twice daily synthetic Human Parathyroid Hormone 1-34.', 'interventionNames': ['Drug: Synthetic Human Parathyroid Hormone 1-34']}, {'type': 'EXPERIMENTAL', 'label': 'Calcitriol & Calcium', 'description': 'All patients received twice daily Calcitriol and Calcium 1000mg divided into four doses daily.', 'interventionNames': ['Drug: Calcitriol & Calcium']}], 'interventions': [{'name': 'Synthetic Human Parathyroid Hormone 1-34', 'type': 'DRUG', 'otherNames': ['teriperitide'], 'description': 'twice daily subcutaneous injections', 'armGroupLabels': ['PTH 1-34']}, {'name': 'Calcitriol & Calcium', 'type': 'DRUG', 'otherNames': ['rocaltrol; 1,25 OH Vitamin D'], 'description': 'Twice daily oral calcitriol with 1000 mg Calcium carbonate supplementation', 'armGroupLabels': ['Calcitriol & Calcium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center, 9000 Rockville Pike', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Karen K Winer, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical officer', 'investigatorFullName': 'Karen K. Winer, M.D.', 'investigatorAffiliation': 'National Institutes of Health Clinical Center (CC)'}}}}