Clinical Trial: Parathyroid Hormone for the Treatment of Humerus Fractures

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase IV Study of the Effect of Parathyroid Hormone on Fractures of the Humerus

Brief Summary:

Hypothesis:

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 Summary:
Sponsor: Hvidovre University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Hvidovre University Hospital

Dates:
Date Received: March 12, 2012
Date Started: March 2012
Date Completion: December 2013
Last Updated: September 13, 2012
Last Verified: September 2012