Status:
RECRUITING
Effects of Teriparatide (PTH) on Bone in Men and Women With Osteoporosis
Lead Sponsor:
University Health Network, Toronto
Conditions:
Osteoporosis
Eligibility:
All Genders
Brief Summary
Teriparatide (PTH) is the only bone formation therapy that has been approved for the treatment of postmenopausal osteoporosis in Canada. Osteoporosis is currently diagnosed using a bone mineral densit...
Detailed Description
Teriparatide (PTH) is the only bone formation therapy that has been approved for the treatment of postmenopausal osteoporosis in Canada. Randomized controlled trials have shown that teriparatide incre...
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
- Ability to obtain teriparatide (not supplied by study sponsor)
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 :
November 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01155232
Start Date
November 1 2004
End Date
January 1 2026
Last Update
June 1 2023
Active Locations (1)
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1
University Health Network, TGH
Toronto, Ontario, Canada, M5G 2C4