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

Shoulder Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00741182
• Other study ID #: FAO_06_011
• Secondary ID: EudraCT 2008-000
• Status: Withdrawn
• Phase: Phase 2
• First received: August 25, 2008
• Last updated: March 17, 2015
• Start date: October 2008
• Est. completion date: September 2010

Study information

• Verified date: August 2009
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Shoulder Fractures
• Trochanteric Fractures

Intervention

Drug:
• rhPTH(1-34)
Injection of 20 micrograms per day in eight weeks

Locations

Country	Name	City	State
Denmark	Research Center for Ageing and Osteoporosis, Glostrup University Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological evaluation of healing		0, 4, 8, 12, (16) weeks after fracture	No
Secondary	Biochemical bone markers		0, 1, 2, 3, 4, 8, 12, (16) weeks after fracture	No
Secondary	SF-36 questionnaire		0, 4, 8, 12, (16) weeks after fracture	No