Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women
NCT00697463 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2018-07-26
Summary
Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures. Teriparatide \[PTH(1-34)\], which is FDA approved for treatment of osteoporosis in men and postmenopausal women, works by stimulating bone formation. The investigators hypothesize that teriparatide will significantly increase bone density (BMD) and improve bone structure in premenopausal women with IOP.
Conditions
- Menopause
- Fracture
- Osteoporosis
Interventions
- DRUG
-
Teriparatide (PTH 1-34)
20 micrograms subcutaneous injection daily
Sponsors & Collaborators
- collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
Elizabeth Shane, MD · Columbia University
-
Adi Cohen, MD · Columbia University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 48 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-08-20
- Primary Completion
- 2012-01-03
- Completion
- 2012-01-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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