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

March 17, 2015 updated by: Glostrup University Hospital, Copenhagen
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Research Center for Ageing and Osteoporosis, Glostrup University Hospital

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

48 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Femur PTH(1-34)
24 participants with trochanteric fractures will be assigned to Forsteo (PTH(1-34)) treatment
Drug: rhPTH(1-34)
Injection of 20 micrograms per day in eight weeks
Other Names:
  • Forteo
  • Teriparatide
  • Forsteo
No Intervention: Femur Control
24 participants with trochanteric fractures will be assigned to "no treatment"
Experimental: Humerus PTH(1-34)
24 participants with collum chirurgicum fracture will be assigned to Forsteo (PTH(1-34)) treatment
Drug: rhPTH(1-34)
Injection of 20 micrograms per day in eight weeks
Other Names:
  • Forteo
  • Teriparatide
  • Forsteo
No Intervention: Humerus Control
24 participants with collum chirurgicum fracture will be assigned to "no treatment".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiological evaluation of healing
Time Frame: 0, 4, 8, 12, (16) weeks after fracture
0, 4, 8, 12, (16) weeks after fracture

Secondary Outcome Measures

Outcome Measure
Time Frame
Biochemical bone markers
Time Frame: 0, 1, 2, 3, 4, 8, 12, (16) weeks after fracture
0, 1, 2, 3, 4, 8, 12, (16) weeks after fracture
SF-36 questionnaire
Time Frame: 0, 4, 8, 12, (16) weeks after fracture
0, 4, 8, 12, (16) weeks after fracture

Collaborators and Investigators

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

Sponsor

Glostrup University Hospital, Copenhagen

Collaborators

The Danish Medical Research Council

Investigators

  • Principal Investigator: Peter Schwarz, MD, DMSci, Glostrup University Hospital

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

October 1, 2008

Primary Completion (Anticipated)

September 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

August 25, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (Estimate)

August 26, 2008

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAO_06_011
  • EudraCT 2008-000094-37

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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