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12 Month Open-Label Extension Study of the Effect of Alendronate on Bone in People With Chronic SCI Previously Treated With Teriparatide
The purpose of this study is to determine if a year of alendronate treatment will maintain or increase bone mass density (BMD) compared to baseline BMD values in people with chronic spinal cord injury (SCI). This study will also investigate 1) if alendronate therapy will increase bone strength in people with chronic SCI, 2) the number of participants with adverse events from alendronate, and 3) the effects of alendronate on serum markers of bone metabolism.
Details
| Lead sponsor | Northwestern University |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 17 |
| Start date | 2014-04 |
| Completion | 2016-08-05 |
Conditions
- Spinal Cord Injury
- Bone Loss
- Osteoporosis
Interventions
- Alendronate
- Calcium
- Vitamin D
Primary outcomes
- BMD of Total Hip by DXA — 12 months
The mean percent change in bone mineral density (BMD) of the hip after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams.
Countries
United States