Status:
UNKNOWN
Teriparatide (PTH) and Bone Strength in Postmenopausal Women
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Osteoporosis
Eligibility:
FEMALE
Brief Summary
This study will investigate the effects on bone quality of a medication (Teriparatide) used to treat people with severe osteoporosis. Teriparatide is the only bone formation therapy that has been appr...
Detailed Description
This study will investigate the effects on bone quality of a medication used to treat severe osteoporosis. Teriparatide (PTH) is the only bone formation therapy that has been approved for the treatmen...
Eligibility Criteria
Inclusion
- History of fragility fracture OR
- High risk for fractures OR
- Very low BMD (T-score ≤ -2.5) OR
- Failed or intolerant to bisphosphonates
- Baseline serum levels of calcium, urate, ALP, PTH, creatinine and 25-hydroxyvitamin D \[25(OH)D\] must be within acceptable normal limits
Exclusion
- History of skeletal irradiation
- Those at increased risk for osteosarcoma
- Diagnosis of Paget's disease
- History of primary hyperparathyroidism
- Significant renal impairment
- Vitamin D deficiency
- On steroids or have other causes of secondary osteoporosis
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01155245
Start Date
June 1 2008
End Date
January 1 2025
Last Update
May 17 2024
Active Locations (1)
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1
University Health Network, TGH
Toronto, Ontario, Canada, M5G 2C4