drugset / Trial / NCT00303485
A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is approximately 7 months, and the target sample size is \<100 individuals.
Timeline
- Start
- 2006-02
- Primary completion
- 2007-06
- Completion
- 2007-06
Outcome
Met primary endpoint
registry Ibandronate vs Placebo; p < 0.0001; Difference in median -64.20 (95% CI -80.28 to -46.21) NCT00303485 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibandronate | Other / unclassified | 150 mg | Oral |
| Background | Calcium | Small molecule | 500 mg | — |
| Background | Vitamin D | Other / unclassified | 200 iu | — |