Parathyroid Hormone for the Treatment of Humerus Fractures
|ClinicalTrials.gov Identifier: NCT01687374|
Recruitment Status : Unknown
Verified September 2012 by Ulrich Bang, Hvidovre University Hospital.
Recruitment status was: Recruiting
First Posted : September 18, 2012
Last Update Posted : September 18, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Fractures||Drug: 1-84 parathyroid hormone Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase IV Study of the Effect of Parathyroid Hormone on Fractures of the Humerus|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2013|
|Placebo Comparator: Placebo||
Saline injection daily for 8 weeks.
|Experimental: Parathyroid hormone||
Drug: 1-84 parathyroid hormone
100 micrograms of 1-84 parathyroid hormone daily for 8 weeks, subcutaneous injection.
- Changes in constant score [ Time Frame: 5, 8, 11, 23, and 104 weeks. ]Constant score summarizes the function of the arm using a questionnaire (activities of daily living - ADL) and functional testing of the arm.
- Changes in Oxford Shoulder Score [ Time Frame: 5, 8, 11, 23, and 104 weeks. ]Oxford shoulder score is a questionnaire that assesses the function of the arm through the evaluation of the participant.
- Changes in bone formation evaluated by X-ray. [ Time Frame: 5, 8, 11, 23, and 104 weeks. ]
- Changes in biochemical bone markers [ Time Frame: 0, 5, 25 weeks ]sodium, potassium, creatinine, liver enzymes, vitamin D, parathyroid hormone, alkaline phosphatase, hemoglobin, magnesium, calcium, zinc.
- Changes in regulatory T lymphocytes [ Time Frame: 0, 8, 24 weeks ]Regulatory CD3+CD4+CD25+Foxp3+ T lymphocytes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687374
|Hvidovre, Denmark, 2650|
|Contact: Lars Hyld, DMSc firstname.lastname@example.org|
|Contact: Ulrich C Bang, M.D. email@example.com|
|Principal Investigator: Ulrich C Bang, M.D.|
|Sub-Investigator: Aage Vestergaard, M.D.|