Phase 4
N=140
A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.
Postmenopausal Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00545051 ↗Enrolled (actual)
140
Serious AEs
11.4%
Results posted
May 2016
Primary outcome: Primary: Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 — 3.2; -0.1 percent change in BMD — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Drug); ibandronate (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- Hoffmann-La Roche
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 |
3.2; -0.1 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6 |
2.6; 0.3 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12 |
0.7; 0.0; 1.2; -0.7 | 0.122 |
| SECONDARY Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12 |
-44.7; -3.8; -53.3; -3.5; -42.0; 11.6 | <0.001 sig |
| SECONDARY Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months |
0.0; 0.0 | — |
Summary
This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- post-menopausal women, 50-85 years of age;
- any inflammatory rheumatoid disease including polymyalgia rheumatica;
- receiving treatment with 5-15 mg/day of prednisolone.
Exclusion Criteria
- previous treatment with an iv bisphosphonate at any time;
- previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within last year, or >3 months of treatment within last 2 years;
- treatment with parathyroid hormone in last 2 years;
- inability to stand or sit in an upright position for at least 60 minutes;
- inability to swallow a tablet whole;
- history of major gastrointestinal disease.
Data sourced from ClinicalTrials.gov (NCT00545051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.