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Parathyroid Hormone for the Treatment of Humerus Fractures

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Hvidovre University Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Ulrich Bang, Hvidovre University Hospital Identifier:
First received: March 12, 2012
Last updated: September 13, 2012
Last verified: September 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 Intervention Phase
Shoulder Fractures
Drug: 1-84 parathyroid hormone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 72
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

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.
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Please refer to this study by its identifier: NCT01687374

Contact: Lars Hyldstrup, MDSc
Contact: Ulrich C Bang, M.D.

Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Lars Hyld, DMSc   
Contact: Ulrich C Bang, M.D.   
Principal Investigator: Ulrich C Bang, M.D.         
Sub-Investigator: Aage Vestergaard, M.D.         
Sponsors and Collaborators
Hvidovre University Hospital
  More Information

Responsible Party: Ulrich Bang, Principal investigator, Hvidovre University Hospital Identifier: NCT01687374     History of Changes
Other Study ID Numbers: HvH-2011-545-1
Study First Received: March 12, 2012
Last Updated: September 13, 2012

Keywords provided by Hvidovre University Hospital:
proximal humeral fracture

Additional relevant MeSH terms:
Fractures, Bone
Shoulder Fractures
Wounds and Injuries
Arm Injuries
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 23, 2017