Parathyroid Hormone for the Treatment of Humerus Fractures
NCT ID: NCT01687374
Last Updated: 2012-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
72 participants
INTERVENTIONAL
2012-03-31
2013-12-31
Brief Summary
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The investigators want to study whether parathyroid hormone improves healing of humerus after a fracture. The investigators will assess healing of the humerus with Constant score.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Saline injection daily for 8 weeks.
Parathyroid hormone
1-84 parathyroid hormone
100 micrograms of 1-84 parathyroid hormone daily for 8 weeks, subcutaneous injection.
Interventions
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1-84 parathyroid hormone
100 micrograms of 1-84 parathyroid hormone daily for 8 weeks, subcutaneous injection.
Placebo
Saline injection daily for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* able to understand the protocol
* signs an informed consent
Exclusion Criteria
* kidney disease
* severe osteoporosis
* malignant disease
* bone metabolic disease
* oral treatment with bisphosphonates during the last 3 months.
* treatment with Denosumab during the last 6 months.
* intravenous treatment with bisphosphonates during the last 12 months.
65 Years
85 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Hvidovre University Hospital
OTHER
Responsible Party
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Ulrich Bang
Principal investigator
Locations
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Hvidovre Hospital
Hvidovre, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Lars Hyld, DMSc
Role: primary
Ulrich C Bang, M.D.
Role: backup
References
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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.
Peichl P, Holzer LA, Maier R, Holzer G. Parathyroid hormone 1-84 accelerates fracture-healing in pubic bones of elderly osteoporotic women. J Bone Joint Surg Am. 2011 Sep 7;93(17):1583-7. doi: 10.2106/JBJS.J.01379.
Other Identifiers
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HvH-2011-545-1
Identifier Type: -
Identifier Source: org_study_id