Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT00145704
Status:
TERMINATED
Last Update Posted:
2013-04-08
First Post:
2005-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D004393', 'term': 'Dwarfism, Pituitary'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068296', 'term': 'Risedronic Acid'}, {'id': 'D002118', 'term': 'Calcium'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'damront@upstate.edu', 'phone': '315-464-8602', 'title': 'Timothy A. Damron', 'organization': 'Upstate Orthopedics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination due to low enrollment, and lost to follow up of three subjects. Data was limited and therefore not reviewed/analyzed'}}, 'adverseEventsModule': {'timeFrame': 'May, 2002 to October 2008', 'eventGroups': [{'id': 'EG000', 'title': 'Bisphosphonate and Growth Hormone Use', 'description': 'bisphosphonate use and growth hormone use', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Growth Hormone Only', 'description': 'Growth hormone use only, no bisphosphonate used', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Body Bone Mineral Density During an 18 Month Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bisphosphonate and Growth Hormone Use', 'description': 'bisphosphonate use and growth hormone use'}, {'id': 'OG001', 'title': 'Growth Hormone Only', 'description': 'Growth hormone use only, no bisphosphonate used'}], 'timeFrame': '18 months', 'description': 'For those patients already on growth hormone replacement therapy, growth hormone will be administered as per standard of care, with standard dose ranges adjusted based upon IGF-1 monitoring. Those patients not currently receiving growth hormone replacement therapy will not be placed on therapy as a part of this study. Patients on and off growth hormone replacement therapy will be randomized in a block design to the two treatment arms to assure equal numbers in each treatment arm. The bisphosphonate to be utilized will be provided to the Arm II patients at no charge. All Arm II patients will receive the same bisphosphonate regimen, Risedronate 35 mg per oral once weekly for 18 months. All patients on arms I and II will also receive Vitamin D (400 IU p.o. daily) and calcium carbonate (500 mg p.o. twice daily) free of charge for eighteen months.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data analyis halted, due to low enrollment,no outcomes to report'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bisphosphonate and Growth Hormone', 'description': 'bisphosphonate use and growth hormone use'}, {'id': 'FG001', 'title': 'Growth Hormone Only', 'description': 'Growth hormone only, no bisphosphonate will be used'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Adult pts from Upstate Med Univ who have known growth hormone deficiency as a complication of treatment for pediatric malignancy will be selected after chart review from their Kids Not on Treatment(KNOT)Clinic records prior to their routine follow up appt.Pts will receive info about this study on their routine f/w up appts at the KNOT Clinic.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bisphosphonate and Growth Hormone Use', 'description': 'bisphosphonate use and growth hormone use'}, {'id': 'BG001', 'title': 'Growth Hormone Only', 'description': 'Growth hormone use only, no bisphosphonate used'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '40'}, {'value': '25', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '40'}, {'value': '25', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'due to low enrollment, participants are no longer being examined or treated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-01', 'studyFirstSubmitDate': '2005-09-01', 'resultsFirstSubmitDate': '2010-10-26', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2013-04-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-01', 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Body Bone Mineral Density During an 18 Month Period', 'timeFrame': '18 months', 'description': 'For those patients already on growth hormone replacement therapy, growth hormone will be administered as per standard of care, with standard dose ranges adjusted based upon IGF-1 monitoring. Those patients not currently receiving growth hormone replacement therapy will not be placed on therapy as a part of this study. Patients on and off growth hormone replacement therapy will be randomized in a block design to the two treatment arms to assure equal numbers in each treatment arm. The bisphosphonate to be utilized will be provided to the Arm II patients at no charge. All Arm II patients will receive the same bisphosphonate regimen, Risedronate 35 mg per oral once weekly for 18 months. All patients on arms I and II will also receive Vitamin D (400 IU p.o. daily) and calcium carbonate (500 mg p.o. twice daily) free of charge for eighteen months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteopenia', 'growth hormone deficiency', 'pediatric malignancy'], 'conditions': ['Osteopenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to evaluate the hypothesis that bisphosphonate treatment given to growth hormone deficient patients (regardless of current growth hormone replacement therapy status and without changing that status) significantly increases total body bone mineral density during an eighteen month period of treatment combined with calcium and Vitamin D when compared to calcium and Vitamin D treatment alone.', 'detailedDescription': 'Adult patients with Dexa scan (bone scan) z-scores \\< -1.0 (meaning low bone density) in at least one site will be selected for randomization. All patients who qualify for randomization will undergo baseline bloodwork for serum bone specific alkaline phosphatase (BSAP) and n-terminal telopeptides of collagen (NTX) levels. Recent bloodwork obtained as part of their ongoing long-term Pediatric Oncology and/or Endocrine clinic follow-up evaluation will be reviewed to exclude any baseline correctable confounding causes of osteopenia (low bone density). All women of childbearing potential will have a pregnancy test.\n\nFor those patients already on growth hormone replacement therapy, growth hormone will be administered as per standard of care, with standard dose ranges adjusted based upon IGF-1(Insulin like growth factor) monitoring. Those patients not currently receiving growth hormone replacement therapy will not be placed on therapy as a part of this study. Patients on and off growth hormone replacement therapy will be randomized in a block design to the two treatment arms to assure equal numbers in each treatment arm. The bisphosphonate to be utilized will be provided to the Arm II patients at no charge. All Arm II patients will receive the same bisphosphonate regimen, Risedronate 35 mg per oral once weekly for 18 months. All patients on arms I and II will also receive Vitamin D (400 IU p.o. daily) and calcium carbonate (500 mg p.o. twice daily) free of charge for eighteen months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Growth hormone deficiency as a complication of treatment for pediatric malignancy\n* Dexa (bone densitometry)with z-scores of \\< -1.0 in at least one site\n\nExclusion Criteria:\n\n* Dexa (bone densitometry)with z-scores \\< -1.0 in at least one site\n* Subjects \\<18 years old\n* Pregnant or lactating patients\n* Any contraindication for or unwillingness to consider bisphosphonate treatment\n* Inability or unwillingness to undergo bone density evaluation\n* Other correctable causes of decreased bone mineral density'}, 'identificationModule': {'nctId': 'NCT00145704', 'briefTitle': 'Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York - Upstate Medical University'}, 'officialTitle': 'Treatment of Childhood Cancer Therapy-induced Osteopenia in Growth Hormone Deficient Adult Survivors: Does Bisphosphonate Treatment Improve Bone Mineral Density?', 'orgStudyIdInfo': {'id': 'SUNY UMU IRB # 4689'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Growth Hormone only', 'description': 'No bisphosphonate therapy given, participants will take Vitamin D 400 IU daily for 18 months, as well as calcium carbonate 500 mg twice a day for 18 months.', 'interventionNames': ['Dietary Supplement: Vitamin D supplement', 'Dietary Supplement: Calcium']}, {'type': 'EXPERIMENTAL', 'label': 'Growth Hormone & Bisphosphonate Therapy', 'description': 'Bisphosphonate Therapy-Risedronate 35 mg once a week for 18 months, Vitamin D 400 IU daily for 18 months and calcium carbonate 500 mg twice daily for 18 months', 'interventionNames': ['Drug: bisphosphonate therapy (risedronate)', 'Dietary Supplement: Vitamin D supplement', 'Dietary Supplement: Calcium']}], 'interventions': [{'name': 'bisphosphonate therapy (risedronate)', 'type': 'DRUG', 'description': 'Bisphosphonate therapy given to patients with growth hormone deficiency', 'armGroupLabels': ['Growth Hormone & Bisphosphonate Therapy']}, {'name': 'Vitamin D supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Over the counter Vitamin D 400 IU.'], 'description': 'Vitamin D given to patients with growth hormone deficiency', 'armGroupLabels': ['Growth Hormone & Bisphosphonate Therapy', 'Growth Hormone only']}, {'name': 'Calcium', 'type': 'DIETARY_SUPPLEMENT', 'description': 'calcium supplement given to patients with growth hormone deficiency', 'armGroupLabels': ['Growth Hormone & Bisphosphonate Therapy', 'Growth Hormone only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}], 'overallOfficials': [{'name': 'Timothy A Damron, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of New York - Upstate Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York - Upstate Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Timothy Damron, M.D.', 'investigatorAffiliation': 'State University of New York - Upstate Medical University'}}}}