Effect of PTH(1-34)-treatment on fracture healing in vivo

• Conditions: pertrocanteric femur fractures or collum humerus fractures in osteoporotic postmenopausal women; MedDRA version: 9.1Level: LLTClassification code 10017082Term: Fracture due to osteoporosis

• Registration Number: EUCTR2008-000094-37-DK
• Lead Sponsor: Glostrup University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Acute new osteoporotic hip fracture or collum chirurgicum fracture
Age 50-85 years
Female
Postmenopause

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Calcium metabolic disease other than osteoporosis
Diseases known to affect calcium homeostasis
Dementia
Hypersensitivity to drug or other components of medication
Pre-existing hypercalcemia
Decreased kidney function
Increased alkaline phosphatase
Prior external radiation therapy or brachytherapy of the skeleton
Skeletal malignancies or bone metastases
Alcohol and/or drug abuse
Systemic treatment with corticosteroids within the last four weeks
Non-cooperating patients
Patients who do not speak and understand the Danish language

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Evaluation of callus formation (callus area) of the fractured bone assessed by x-ray, during and after PTH(1-34)-treatment.;Main Objective: Primary objective of the study is to demonstrate the stimulatory effect of PTH(1-34) on bone healing measured by callus formation (callus area) as determined by x-ray analysis .<br><br>;Secondary Objective: The secondary objectives are to determine the effect of PTH(1-34), during fracture healing, on biochemical markers of bone formation (Alkaline phosphatase, s-osteocalcin, s-P1CP) and resorption (s-NTX), bone mineral density (BMD) and bone mineral content (BMC). Furthermore life quality of the patients will be evaluated using SF-36 questionnaire.