Effect of PTH(1-34) Treatment on Fracture Healing in Vivo

Phase 2

Withdrawn

• Conditions: Trochanteric Fractures; Shoulder Fractures
• Interventions: Drug: rhPTH(1-34)

• Registration Number: NCT00741182
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief Summary

The purpose of the study is to investigate, whether PTH(1-34) is able to promote fracture healing in postmenopausal women with fractures of the hip or shoulder.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-25
• Study First Posted: 2008-08-26
• Study Start: 2008-10
• Status Verified: 2009-08
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Acute new osteoporotic trochanteric or collum chirurgicum fracture
• Postmenopause

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
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femur PTH(1-34)	rhPTH(1-34)	24 participants with trochanteric fractures will be assigned to Forsteo (PTH(1-34)) treatment
Humerus PTH(1-34)	rhPTH(1-34)	24 participants with collum chirurgicum fracture will be assigned to Forsteo (PTH(1-34)) treatment

Primary Outcome Measures

Name	Time	Method
Radiological evaluation of healing	0, 4, 8, 12, (16) weeks after fracture

Secondary Outcome Measures

Name	Time	Method
Biochemical bone markers	0, 1, 2, 3, 4, 8, 12, (16) weeks after fracture
SF-36 questionnaire	0, 4, 8, 12, (16) weeks after fracture

Trial Locations

Locations (1)

Research Center for Ageing and Osteoporosis, Glostrup University Hospital; 🇩🇰 Copenhagen, Denmark