Parathyroid Hormone for the Treatment of Humerus Fractures

September 13, 2012 updated by: Ulrich Bang, Hvidovre University Hospital

Phase IV Study of the Effect of Parathyroid Hormone on Fractures of the Humerus

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Recruiting
        • Hvidovre Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ulrich C Bang, M.D.
        • Sub-Investigator:
          • Aage Vestergaard, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5, 8, 11, 23, and 104 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5, 8, 11, 23, and 104 weeks.
Changes in bone formation evaluated by X-ray.
Time Frame: 5, 8, 11, 23, and 104 weeks.
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.
0, 5, 25 weeks
Changes in regulatory T lymphocytes
Time Frame: 0, 8, 24 weeks
Regulatory CD3+CD4+CD25+Foxp3+ T lymphocytes.
0, 8, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Collaborators

Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

September 13, 2012

First Posted (Estimate)

September 18, 2012

Study Record Updates

Last Update Posted (Estimate)

September 18, 2012

Last Update Submitted That Met QC Criteria

September 13, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HvH-2011-545-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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