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

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ClinicalTrials.gov Identifier: NCT00741182
Recruitment Status : Withdrawn
First Posted : August 26, 2008
Last Update Posted : March 18, 2015
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Shoulder Fractures Trochanteric Fractures Drug: rhPTH(1-34) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of PTH(1-34) Treatment on Fracture Healing in Vivo
Study Start Date : October 2008
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arms and Interventions

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:
  • 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".


Outcome Measures

Primary Outcome Measures :
  1. Radiological evaluation of healing [ Time Frame: 0, 4, 8, 12, (16) weeks after fracture ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741182


Locations
Denmark
Research Center for Ageing and Osteoporosis, Glostrup University Hospital
Copenhagen, Denmark
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
The Danish Medical Research Council
Investigators
Principal Investigator: Peter Schwarz, MD, DMSci Glostrup University Hospital
More Information

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
First Posted: August 26, 2008    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: August 2009

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

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