Effects of Teriparatide on Bone in Osteoporosis Patients
Effect of 24 Months of Teriparatide Therapy on Bone Microarchitecture and Bone Volume in Men and Women With Osteoporosis
This study tests how a treatment called teriparatide affects bone strength and structure in men and women with osteoporosis over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT01155232 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of teriparatide, a bone formation therapy, on bone structure and mineral density in men and women diagnosed with osteoporosis. The study aims to assess changes in cortical and trabecular bone characteristics at the radius and tibia over a 24-month period using high-resolution peripheral quantitative computed tomography (HR-pQCT). By analyzing these changes, the research seeks to provide insights into how teriparatide therapy influences bone geometry and strength, beyond what is measured by traditional bone mineral density scans.
Who should consider this trial
Good fit: Ideal candidates for this study include individuals with a history of fragility fractures, high fracture risk, very low bone mineral density, or those who have failed or are intolerant to bisphosphonates.
Not a fit: Patients with a history of skeletal irradiation, increased risk for osteosarcoma, or significant renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how teriparatide improves bone health, potentially leading to better treatment strategies for osteoporosis.
How similar studies have performed: Previous studies have shown positive outcomes with teriparatide in increasing bone mineral density, but this specific focus on bone geometry using HR-pQCT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Toronto, Ontario
- University Health Network, TGH — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Angela m Cheung, MD, PhD — University Health Network, Toronto
- Study coordinator: Jessica Chang, RN
- Email: jessica.chang@uhn.on.ca
- Phone: 416-340-4800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.