Effect of PTH(1-34) Treatment on Fracture Healing in Vivo
Information source: Glostrup University Hospital, Copenhagen
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Shoulder Fractures; Trochanteric Fractures
Intervention: rhPTH(1-34) (Drug)
Phase: Phase 2
Status: Withdrawn
Sponsored by: Glostrup University Hospital, Copenhagen Official(s) and/or principal investigator(s): Peter Schwarz, MD, DMSci, Principal Investigator, Affiliation: Glostrup University Hospital
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.
Clinical Details
Official title: Effect of PTH(1-34) Treatment on Fracture Healing in Vivo
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Radiological evaluation of healing
Secondary outcome: Biochemical bone markersSF-36 questionnaire
Eligibility
Minimum age: 50 Years.
Maximum age: 85 Years.
Gender(s): Female.
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
Locations and Contacts
Research Center for Ageing and Osteoporosis, Glostrup University Hospital, Copenhagen, Denmark
Additional Information
Starting date: October 2008
Last updated: March 17, 2015
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