Parathyroid Hormone for the Treatment of Humerus Fractures

Phase 4

• Conditions: Shoulder Fractures
• Interventions: Drug: Placebo; Drug: 1-84 parathyroid hormone

• Registration Number: NCT01687374
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-12
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-13
• Last Update Submitted: 2012-09-13
• Study First Posted: 2012-09-18
• Last Update Posted: 2012-09-18
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Parathyroid hormone	1-84 parathyroid hormone	-

Primary Outcome Measures

Name	Time	Method
Changes in constant score	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

Name	Time	Method
Changes in Oxford Shoulder Score	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.	5, 8, 11, 23, and 104 weeks.
Changes in biochemical bone markers	0, 5, 25 weeks	sodium, potassium, creatinine, liver enzymes, vitamin D, parathyroid hormone, alkaline phosphatase, hemoglobin, magnesium, calcium, zinc.
Changes in regulatory T lymphocytes	0, 8, 24 weeks	Regulatory CD3+CD4+CD25+Foxp3+ T lymphocytes.

Trial Locations

Locations (1)

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark