Phase 4
N=160
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia
Post-Menopausal Osteopenia
Bottom Line
View on ClinicalTrials.gov: NCT00129623 ↗Enrolled (actual)
160
Serious AEs
2.5%
Results posted
Jan 2016
Primary outcome: Primary: Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12 — -0.3941; 3.7285 Percentage — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Drug); ibandronate [Bonviva/Boniva] (Drug)
- Age
- Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12 |
-0.3941; 3.7285 | <0.0001 sig |
| SECONDARY Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12 |
-0.0039; 0.0322 | — |
| SECONDARY Relative Change From Baseline in Mean Proximal Femur BMD at Month 12 |
-0.9265; 1.4855; -0.9120; 2.8688; -0.7537; 1.0930 | — |
| SECONDARY Absolute Change From Baseline in BMD of the Proximal Femur at Month 12 |
-0.0083; 0.0133; -0.0061; 0.0182; -0.0061; 0.0078 | — |
| SECONDARY Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX) |
-4.2230; -55.7688; -6.5934; -61.6459; -6.7416; -56.5432 | — |
| SECONDARY Absolute Change From Baseline in sCTX |
-0.0350; -0.2570; -0.0350; -0.2675; -0.0320; -0.2560 | — |
| SECONDARY Percentage of Responders |
38.6; 88.2; 15.5; 60.3; 8.5; 54.4 | — |
| SECONDARY Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) |
64; 60; 1; 3 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities |
1; 0; 2; 0; 1; 0 | — |
Summary
This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- women 45-60 years of age;
- post-menopausal;
- ambulatory.
Exclusion Criteria
- vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
- low-trauma osteoporotic fracture in any other bone;
- breast cancer diagnosed within last 20 years;
- other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;
- treatment with any bisphosphonate within last 2 years;
- treatment with other drugs affecting bone metabolism within last 6 months.
Data sourced from ClinicalTrials.gov (NCT00129623). 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.