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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Danish Medical Research Council
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00741182
First received: August 25, 2008
Last updated: August 4, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Shoulder Fractures
Trochanteric Fractures
 Drug: rhPTH(1-34)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of PTH(1-34) Treatment on Fracture Healing in Vivo

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Radiological evaluation of healing [ Time Frame: 0, 4, 8, 12, (16) weeks after fracture ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical bone markers [ Time Frame: 0, 1, 2, 3, 4, 8, 12, (16) weeks after fracture ] [ Designated as safety issue: No ]
  • SF-36 questionnaire [ Time Frame: 0, 4, 8, 12, (16) weeks after fracture ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: October 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Forsteo
  • Forteo
  • Teriparatide
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:
  • Forsteo
  • Forteo
  • Teriparatide
No Intervention: Humerus Control
24 participants with collum chirurgicum fracture will be assigned to "no treatment".

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741182

Locations
Denmark
Research Center for Ageing and Osteoporosis, Glostrup University Hospital Recruiting
Copenhagen, Denmark
Contact: Maria Ellegaard, M.sc.     +45 43234695     marlar04@glo.regionh.dk    
Principal Investigator: Peter Schwarz, MD, DMSci            
Sub-Investigator: Tommy K Larsen, MD            
Sub-Investigator: Maria Ellegaard, M.sc.            
Sub-Investigator: Niklas R Jørgensen, MD,PhD,DMSci            
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
The Danish Medical Research Council
Investigators
Principal Investigator: Peter Schwarz, MD, DMSci Glostrup University Hospital
  More Information

No publications provided

Responsible Party: Peter Schwarz, Professor, MD, DMSci, Glostrup University Hospital
ClinicalTrials.gov Identifier: NCT00741182     History of Changes
Other Study ID Numbers: FAO_06_011, EudraCT 2008-000094-37
Study First Received: August 25, 2008
Last Updated: August 4, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

Keywords provided by Glostrup University Hospital, Copenhagen:
Fracture
Osteoporosis
Forsteo
Teriparatide
Fracture healing

Additional relevant MeSH terms:
Fractures, Bone
Shoulder Fractures
Hip Fractures
Wounds and Injuries
Arm Injuries
Femoral Fractures
 Hip Injuries
Leg Injuries
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013