Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 6:32 PM
Study NCT ID:
NCT01105832
Status:
COMPLETED
Last Update Posted:
2014-12-10
First Post:
2010-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Teriparatide (rhPTH 1-34) Promote Fracture Healing in Proximal Humeral Fractures?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-11-24', 'releaseDate': '2015-10-22'}, {'resetDate': '2016-02-16', 'releaseDate': '2016-01-20'}, {'resetDate': '2016-03-11', 'releaseDate': '2016-02-17'}, {'resetDate': '2016-06-23', 'releaseDate': '2016-05-16'}, {'resetDate': '2018-07-12', 'releaseDate': '2017-09-19'}, {'resetDate': '2021-05-18', 'releaseDate': '2021-04-28'}], 'estimatedResultsFirstSubmitDate': '2015-10-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006810', 'term': 'Humeral Fractures'}, {'id': 'D012784', 'term': 'Shoulder Fractures'}], 'ancestors': [{'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-09', 'studyFirstSubmitDate': '2010-04-13', 'studyFirstSubmitQcDate': '2010-04-16', 'lastUpdatePostDateStruct': {'date': '2014-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment', 'timeFrame': '7 weeks'}], 'secondaryOutcomes': [{'measure': 'Function', 'timeFrame': '7 weeks and 3 months', 'description': 'The function in the upper extremity will be measured using DASH. The experimental group will be compared with the control group'}, {'measure': 'Pain', 'timeFrame': '7 weeks and 3 months', 'description': 'Pain at rest and during activity will be measured using a visual analogue scale (VAS). The experimental group will be compared with the control group'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Teriparatide', 'fracture healing', 'proximal humeral fractures'], 'conditions': ['Humeral Fracture']}, 'referencesModule': {'references': [{'pmid': '19594305', 'type': 'RESULT', 'citation': 'Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731.'}, {'pmid': '20367417', 'type': 'RESULT', 'citation': 'Aspenberg P, Johansson T. Teriparatide improves early callus formation in distal radial fractures. Acta Orthop. 2010 Apr;81(2):234-6. doi: 10.3109/17453671003761946.'}, {'pmid': '26179771', 'type': 'DERIVED', 'citation': 'Johansson T. PTH 1-34 (teriparatide) may not improve healing in proximal humerus fractures. A randomized, controlled study of 40 patients. Acta Orthop. 2016 Feb;87(1):79-82. doi: 10.3109/17453674.2015.1073050. Epub 2015 Jul 15.'}]}, 'descriptionModule': {'briefSummary': '40 postmenopausal women, with a non-operated proximal humeral fracture, will be randomized to standard treatment (physiotherapy) or standard treatment + Forsteo (rhPTH 1-34) during 4 weeks. Follow-up will be at 7 weeks and 3 months including x-ray and DASH score (The Disabilities of the Arm, Shoulder and Hand) measuring physical function, and pain on a visual analoge scale (VAS).\n\nTwo doctors, blinded to the treatment, will judge the callus formation and healing on the x-rays and guess the treatment. The DASH score and the pain score will be compared between the treatment groups.\n\nThe investigators hypotheses are that callus formation and healing will be more pronounced and that patients have less pain and better function in the rhPTH 1-34 group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* proximal humeral fracture\n* postmenopausal woman 50 years or older\n* non-surgical treatment\n\nExclusion Criteria:\n\n* dementia or psychiatric disorder\n* known malignancy \\< 5 years prior to fracture\n* calcium above reference value\n* signs of liver disease\n* creatinine over ref. value\n* inflammatory joint disease\n* alcohol or drug abuse\n* oral corticosteroid medication\n* long-term NSAID-treatment (=\\> 3 months prior to fracture)'}, 'identificationModule': {'nctId': 'NCT01105832', 'briefTitle': 'Does Teriparatide (rhPTH 1-34) Promote Fracture Healing in Proximal Humeral Fractures?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'officialTitle': 'Påskyndar PTH läkningen av Konservativt Behandlade Humerusfrakturer?', 'orgStudyIdInfo': {'id': '2009-017320-29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proximal humeral fracture - intervention', 'description': '20 patients will be randomized to 20 micrograms daily of Teriparatide (Forsteo)', 'interventionNames': ['Drug: Teriparatide']}, {'type': 'NO_INTERVENTION', 'label': 'Proximal humeral fracture', 'description': '20 patients will receive standard treatment (physiotherapy)'}], 'interventions': [{'name': 'Teriparatide', 'type': 'DRUG', 'description': 'Teriparatide (Forsteo) 20 micrograms daily during four weeks', 'armGroupLabels': ['Proximal humeral fracture - intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Motala', 'country': 'Sweden', 'facility': 'Lasarettet i Motala', 'geoPoint': {'lat': 58.53706, 'lon': 15.03649}}, {'city': 'Norrköping', 'country': 'Sweden', 'facility': 'Department of Orthopaedics', 'geoPoint': {'lat': 58.59419, 'lon': 16.1826}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Torsten Johansson', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-10-22', 'type': 'RELEASE'}, {'date': '2015-11-24', 'type': 'RESET'}, {'date': '2016-01-20', 'type': 'RELEASE'}, {'date': '2016-02-16', 'type': 'RESET'}, {'date': '2016-02-17', 'type': 'RELEASE'}, {'date': '2016-03-11', 'type': 'RESET'}, {'date': '2016-05-16', 'type': 'RELEASE'}, {'date': '2016-06-23', 'type': 'RESET'}, {'date': '2017-09-19', 'type': 'RELEASE'}, {'date': '2018-07-12', 'type': 'RESET'}, {'date': '2021-04-28', 'type': 'RELEASE'}, {'date': '2021-05-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Torsten Johansson, MD, PhD, University Hospital, Linkoeping'}}}}