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Parathyroid Hormone for the Treatment of Humerus Fractures

This study is currently recruiting participants.
Verified September 2012 by Hvidovre University Hospital
Sponsor:
Collaborator:
Nycomed: A Takeda Company
Information provided by (Responsible Party):
Ulrich Bang, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01687374
First received: March 12, 2012
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Shoulder Fractures
 Drug: 1-84 parathyroid hormone
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • Changes in biochemical bone markers [ Time Frame: 0, 5, 25 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Nycomed: A Takeda Company
  More Information

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
Study First Received: March 12, 2012
Last Updated: September 13, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by Hvidovre University Hospital:
proximal humeral fracture

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

ClinicalTrials.gov processed this record on May 16, 2013