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Parathyroid Hormone for the Treatment of Humerus Fractures

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Hvidovre University Hospital
Sponsor:
Collaborator:
Takeda
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Takeda
  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 August 21, 2014