Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 4:55 PM
Study NCT ID:
NCT00131469
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2005-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010013', 'term': 'Osteogenesis Imperfecta'}], 'ancestors': [{'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019379', 'term': 'Teriparatide'}], 'ancestors': [{'id': 'D010281', 'term': 'Parathyroid Hormone'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'orwoll@ohsu.edu', 'phone': '15034940225', 'title': 'Eric Orwoll', 'organization': 'OHSU'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '18 months', 'eventGroups': [{'id': 'EG000', 'title': 'Teriparatide (FORTEO)', 'description': 'Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months\n\nTeriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Daily SQ placebo for 18 months\n\nPlacebos', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Spine Bone Mineral Density (BMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide (FORTEO)', 'description': 'Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months\n\nTeriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily SQ placebo for 18 months\n\nPlacebos'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 18 months', 'description': 'bone density by dual energy xray absorptiometry', 'unitOfMeasure': 'percentage of change in g/cm2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Hip BMD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide (FORTEO)', 'description': 'Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months\n\nTeriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily SQ placebo for 18 months\n\nPlacebos'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '2', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 18 months', 'description': 'bone density by dual energy xray absorptiometry', 'unitOfMeasure': 'percentage of change in g/cm2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Teriparatide (FORTEO)', 'description': 'Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months\n\nTeriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Daily SQ placebo for 18 months\n\nPlacebos'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'scan not analyzable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'One participant was formally enrolled but then dropped out before the first study treatment was administered.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Teriparatide (FORTEO)', 'description': 'Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months\n\nTeriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Daily SQ placebo for 18 months\n\nPlacebos'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.8', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '41.2', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '41', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2005-08-16', 'resultsFirstSubmitDate': '2019-03-14', 'studyFirstSubmitQcDate': '2005-08-16', 'lastUpdatePostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-04', 'studyFirstPostDateStruct': {'date': '2005-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spine Bone Mineral Density (BMD)', 'timeFrame': 'baseline and 18 months', 'description': 'bone density by dual energy xray absorptiometry'}], 'secondaryOutcomes': [{'measure': 'Total Hip BMD', 'timeFrame': 'baseline and 18 months', 'description': 'bone density by dual energy xray absorptiometry'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteogenesis Imperfecta', 'Brittle Bone Disease', 'Fragility Fractures'], 'conditions': ['Osteogenesis Imperfecta']}, 'referencesModule': {'references': [{'pmid': '24463451', 'type': 'DERIVED', 'citation': 'Orwoll ES, Shapiro J, Veith S, Wang Y, Lapidus J, Vanek C, Reeder JL, Keaveny TM, Lee DC, Mullins MA, Nagamani SC, Lee B. Evaluation of teriparatide treatment in adults with osteogenesis imperfecta. J Clin Invest. 2014 Feb;124(2):491-8. doi: 10.1172/JCI71101. Epub 2014 Jan 27.'}], 'seeAlsoLinks': [{'url': 'http://oif.org', 'label': 'Osteogenesis Imperfecta Foundation'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in adults affected with Osteogenesis Imperfecta (OI).', 'detailedDescription': 'The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in adults affected with Osteogenesis Imperfecta (OI). Osteogenesis imperfecta is an inherited disorder of type I collagen, a major component of bones, and is characterized by multiple fractures and deformities. OI affects approximately 1-2 of every 10,000 individuals. Virtually all of the studies of potential treatments for OI have evaluated the effects of medications only on children with OI. There is no cure for osteogenesis imperfecta and there is no established medical therapy for adults with the disorder. There are very limited data concerning the usefulness of parathyroid hormone therapy in OI. An effective anabolic therapy for the treatment of adult patients with OI could be a valuable asset to the affected patients. In this study, the working hypothesis is that individuals affected with OI who are treated with Forteo will experience increased spine and hip bone mineral density and an increase in bone strength. Although Forteo is not expected to change the defect in the collagen produced, but is postulated to increase the quantity of bone formed and improve bone strength.\n\nThis will be a placebo controlled, double blinded trial; half the patients will receive Forteo 20 ug/day SQ. Adult patients (age at least 18 yrs) with OI will be enrolled for a treatment duration of 18 months. Blood, urine, and bone density/strength tests will be done during the study to assess efficacy and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous established diagnosis of Osteogenesis Imperfecta AND\n* \\> 2 previous adult fractures, AND/OR\n* BMD at lumbar spine, femoral neck or total hip T score \\< -2.0\n\nExclusion Criteria:\n\n* Open epiphyses.\n* History of external beam radiation to the skeleton.\n* Pagets disease.\n* Bone metastases or skeletal malignancies.\n* Total lifetime exposure to any antiresorptive medication \\< 90 days (Primary Inclusion).\n* Treatment with any antiresorptive medication 12 months proceeding enrollment - (Secondary Inclusion).\n* Women with OI who are pregnant or unwilling to use 1 form of contraception.\n* Vitamin D insufficiency (25-hydroxyvitamin D \\<15ng/ml)'}, 'identificationModule': {'nctId': 'NCT00131469', 'acronym': 'OI', 'briefTitle': 'Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'A Study to Assess the Effectiveness of Teriparatide (FORTEO) for Increasing Bone Mass and Improving Bone Strength in Adults Affected With Osteogenesis Imperfecta (OI)', 'orgStudyIdInfo': {'id': 'IBMD-OI'}, 'secondaryIdInfos': [{'id': 'UL1RR024140', 'link': 'https://reporter.nih.gov/quickSearch/UL1RR024140', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Teriparatide (FORTEO)', 'description': 'Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months', 'interventionNames': ['Drug: Teriparatide (FORTEO)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Daily SQ placebo for 18 months', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Teriparatide (FORTEO)', 'type': 'DRUG', 'otherNames': ['FORTEO'], 'description': 'Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily', 'armGroupLabels': ['Teriparatide (FORTEO)']}, {'name': 'Placebos', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Kennedy Krieger Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '97239-3098', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine, Department of Molecular and Human Gentics', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Eric S Orwoll, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}, {'name': 'Jay Shapiro, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hugo W. Moser Research Institute at Kennedy Krieger, Inc.'}, {'name': 'Brendan Lee, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Balor College of Medicine'}, {'name': 'Sandra Veith, CRA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, {'name': 'Osteogenesis Imperfecta Foundation', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Of Medicine', 'investigatorFullName': 'Eric Orwoll, MD', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}