Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT02580604
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2015-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PTH And Calcium Responses to Exercise in Older Adults Experiment 2 (PACE Sr. 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'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': 'D002122', 'term': 'Calcium Chloride'}, {'id': 'D002125', 'term': 'Calcium Gluconate'}], 'ancestors': [{'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D005942', 'term': 'Gluconates'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarah.wherry@cuanschutz.edu', 'phone': '303-724-1927', 'title': 'Dr. Sarah Wherry', 'organization': 'University of Colorado Anschutz Medical Campus'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'This study was not intended to treat or prevent any disease/illness. All participants were generally healthy at time of enrollment.', 'eventGroups': [{'id': 'EG000', 'title': 'Calcium Infusion', 'description': 'Continuous calcium infusion during exercise\n\nCalcium Chloride/Calcium Gluconate: Calcium (as either calcium chloride or calcium gluconate in half normal saline) will be delivered via IV during exercise to keep serum ionized calcium levels above baseline. The clamp is modeled after the hyperglycemic glucose clamp.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Saline Infusion', 'description': 'Continuous saline infusion during exercise\n\nPlacebo: Saline Infusion', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Parathyroid Hormone (PTH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Infusion', 'description': 'Continuous calcium infusion during exercise'}, {'id': 'OG001', 'title': 'Saline Infusion', 'description': 'Continuous saline infusion during exercise'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '13.4'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': '28.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 60 minutes', 'description': 'Change in PTH will be measured from baseline to end of exercise', 'unitOfMeasure': 'pg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in C-telopeptide (CTX)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Infusion', 'description': 'Continuous calcium infusion during exercise'}, {'id': 'OG001', 'title': 'Saline Infusion', 'description': 'Continuous saline infusion during exercise'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '-0.03', 'upperLimit': '0.06'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.18'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 60 minutes', 'description': 'Change in CTX will be measured from baseline to the end of 60 minutes of exercise', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Ionized Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Infusion', 'description': 'Continuous calcium infusion during exercise'}, {'id': 'OG001', 'title': 'Saline Infusion', 'description': 'Continuous saline infusion during exercise'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.20'}, {'value': '-0.15', 'groupId': 'OG001', 'lowerLimit': '-0.29', 'upperLimit': '-0.01'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 60 minutes', 'description': 'Change in ionized calcium will be measured from baseline to the end of 60 minutes of exercise', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Calcium Infusion First, Saline Infusion Second', 'description': 'Continuous calcium infusion during exercise\n\nCalcium Chloride/Calcium Gluconate: Calcium (as either calcium chloride or calcium gluconate in half normal saline) will be delivered via IV during exercise to keep serum ionized calcium levels above baseline. The clamp is modeled after the hyperglycemic glucose clamp.\n\nThe second infusion will be half-normal saline following the same infusion schedule and dosing as the calcium infusion.'}], 'periods': [{'title': 'Calcium First', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Saline Second', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Calcium Infusion', 'description': 'Continuous calcium infusion during exercise'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.5', 'spread': '5.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-13', 'size': 550751, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-05T12:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2015-10-16', 'resultsFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2015-10-16', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-11', 'studyFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Parathyroid Hormone (PTH)', 'timeFrame': 'baseline, 60 minutes', 'description': 'Change in PTH will be measured from baseline to end of exercise'}], 'secondaryOutcomes': [{'measure': 'Change in C-telopeptide (CTX)', 'timeFrame': 'baseline, 60 minutes', 'description': 'Change in CTX will be measured from baseline to the end of 60 minutes of exercise'}, {'measure': 'Change in Ionized Calcium', 'timeFrame': 'baseline, 60 minutes', 'description': 'Change in ionized calcium will be measured from baseline to the end of 60 minutes of exercise'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'Declines in serum calcium during exercise may cause increases in markers of bone resorption. This study will determine if preventing the decline serum ionized calcium experienced at the onset of exercise through the use of a "calcium clamp" also prevents increases in blood biomarkers associated with bone resorption.', 'detailedDescription': 'Participants will undergo two identical walking exercise sessions on a treadmill. One session will occur until continuous calcium infusion and the other will be under continuous saline infusion. C-telopeptide, parathyroid hormone, total calcium, and serum ionized calcium will be monitored to distinguish differences in bone activity under the two conditions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults aged 60-80 y\n* Currently taking a bisphosphonate medication\n\nExclusion Criteria:\n\n* Use of medications (other than bisphosphonates) in the past 6 months known to affect bone metabolism (e.g., thiazide diuretics, oral glucocorticoids)\n* Bone Mineral Density (BMD) t score \\< -3.0 at the total hip or lumbar spine\n* Known disease or condition associated with intestinal malabsorption\n* Moderate or severe renal impairment defined as an estimated glomerular filtration rate of \\<60 mL/min/1.73m2 based on the Modified Diet in Renal Disease (MDRD) equation\n* Chronic hepatobiliary disease, defined as liver function tests (AST, ALT) \\>1.5 times the upper limit of normal; if such values are obtained on initial screening and thought to be transient in nature, repeated testing will be allowed\n* Thyroid dysfunction, defined as an ultrasensitive TSH \\<0.5 or \\>5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement\n* Serum calcium \\<8.5 or \\>10.3 mg/dL Serum 25(OH)D \\<20 ng/mL; volunteers with abnormal serum 25(OH)D values may be re-considered for participation in the study if serum 25(OH)D is \\>20 ng/mL after vitamin D supplementation\n* Uncontrolled hypertension defined as resting systolic BP \\>150 mmHg or diastolic BP\\>90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the PCP with initiation or adjustment of anti-hypertensive medications\n* History of type 1 or type 2 diabetes\n* Cardiovascular disease; subjective or objective indicators of ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test (GXT) without follow-up evaluation will be cause for exclusion; follow-up evaluation must include diagnostic testing (e.g., stress echocardiogram or thallium stress test) with interpretation by a cardiologist\n* Diagnosis or history of asthma'}, 'identificationModule': {'nctId': 'NCT02580604', 'briefTitle': 'PTH And Calcium Responses to Exercise in Older Adults Experiment 2 (PACE Sr. 2)', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'PTH And Calcium Responses to Exercise in Older Adults Experiment 2 (PACE Sr. 2)', 'orgStudyIdInfo': {'id': '15-0878'}, 'secondaryIdInfos': [{'id': 'UM1TR004399', 'link': 'https://reporter.nih.gov/quickSearch/UM1TR004399', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calcium Infusion followed by Saline Infusion', 'description': 'All participants will have a continuous calcium infusion during exercise at their first collection visit. The second collection visit will always be a volume-matched half-normal saline infusion.', 'interventionNames': ['Drug: Calcium Chloride/Calcium Gluconate', 'Drug: Half-Normal Saline']}], 'interventions': [{'name': 'Calcium Chloride/Calcium Gluconate', 'type': 'DRUG', 'description': 'Calcium (as either calcium chloride or calcium gluconate in half normal saline) will be delivered via IV during exercise to keep serum ionized calcium levels above baseline. The clamp is modeled after the hyperglycemic glucose clamp.', 'armGroupLabels': ['Calcium Infusion followed by Saline Infusion']}, {'name': 'Half-Normal Saline', 'type': 'DRUG', 'description': 'This is the placebo comparative infusion. Half-normal saline will be infused at the second collection visit following the identical infusion schedule determined during the calcium infusion visit.', 'armGroupLabels': ['Calcium Infusion followed by Saline Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Sarah J Wherry, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}