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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
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Ulrich Bang, Hvidovre University Hospital

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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: 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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Changes in bone formation evaluated by X-ray. [ Time Frame: 5, 8, 11, 23, and 104 weeks. ]
  3. 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.

  4. Changes in regulatory T lymphocytes [ Time Frame: 0, 8, 24 weeks ]
    Regulatory CD3+CD4+CD25+Foxp3+ T lymphocytes.



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Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • proximal humeral fracture eligible for conservative treatment.
  • able to understand the protocol
  • signs an informed consent

Exclusion Criteria:

  • liver disease
  • 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.

Information from the National Library of Medicine

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


Contacts
Contact: Lars Hyldstrup, MDSc hyld@dadlnet.dk
Contact: Ulrich C Bang, M.D. ulrichbangbang@gmail.com

Locations
Denmark
Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Lars Hyld, DMSc       hyld@dadlnet.dk   
Contact: Ulrich C Bang, M.D.       ulrichbangbang@gmail.com   
Principal Investigator: Ulrich C Bang, M.D.         
Sub-Investigator: Aage Vestergaard, M.D.         
Sponsors and Collaborators
Hvidovre University Hospital
Takeda

Publications:
Responsible Party: Ulrich Bang, Principal investigator, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01687374     History of Changes
Other Study ID Numbers: HvH-2011-545-1
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: September 2012

Keywords provided by Ulrich Bang, Hvidovre University Hospital:
proximal humeral fracture

Additional relevant MeSH terms:
Fractures, Bone
Shoulder Fractures
Wounds and Injuries
Shoulder Injuries
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs