Parathyroid Hormone for the Treatment of Humerus Fractures
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687374
|Contact: Lars Hyldstrup, MDScfirstname.lastname@example.org|
|Contact: Ulrich C Bang, M.D.||email@example.com|
|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.|