Phase 4
N=356
A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
Post Menopausal Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00377234 ↗Enrolled (actual)
356
Serious AEs
1.2%
Results posted
Jul 2015
Primary outcome: Primary: Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing — 81.7; 78.2; 79.9 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Risedronate (Drug); ibandronate [Bonviva/Boniva] (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Female
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing |
81.7; 78.2; 79.9 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate |
85.5; 87.0; 86.3 | — |
| SECONDARY Intensity of Upper Gastrointestinal (GI) Symptoms |
46.1; 56.5; 41.3; 49.1; 32.3; 36.0 | — |
| SECONDARY Mean Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP) |
— | — |
| SECONDARY Median Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP) |
— | — |
Summary
This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- ambulatory women with post-menopausal osteoporosis;
- patients who are bisphosphonate-naive, or who have previously received oral daily or i.v. bisphosphonate therapy (fulfilling certain criteria detailed in the protocol).
Exclusion Criteria
- malignant disease diagnosed within previous 10 years (except for successfully resected basal cell cancer;) breast cancer within previous 20 years;
- inability to stand or sit upright for at least 60 minutes;
- disease/disorder/treatment with drugs known to influence bone metabolism.
Data sourced from ClinicalTrials.gov (NCT00377234). 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.