Trial information
A Study Comparing Monthly Bonviva (Ibandronate) and Weekly Alendronate in Women With Post-Menopausal Osteoporosis.
Status: Completed
Protocol number: ML18029
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study to compare the effects, in terms of bone mineral density, serum CTX and safety, of monthly Bonviva and weekly alendronate in women with post-menopausal osteoporosis
Brief summary: This study will compare the efficacy and safety of once monthly oral Bonviva (150mg) and once weekly oral alendronate (70mg) in women with postmenopausal osteoporosis. Patients will be randomized to one of the 2 active treatment groups, and all patients will also receive daily supplementation with vitamin D and calcium. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is
320.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Post-Menopausal Osteoporosis
Intervention type: Drug
Intervention name: ibandronate[Bonviva/Boniva]
Primary outcome: 1. Relative change from baseline in mean lumbar spine BMD at 12 months.
Key secondary outcomes: 1. Efficacy: Relative change from baseline in total hip BMD at 12 months. Relative and absolute change in serum CTX at 3, 6 and 12 months. Safety: AEs (including fractures), laboratory tests.
Inclusion criteria:
- women aged 47-80, at least 2 years after natural menopause;
- lumbar spine or total hip BMD <= -2.5 SD T-score;
- ambulatory at beginning of trial.
Exclusion criteria:
- malignant disease diagnosed within previous 10 years (except basal cell cancer that has been successfully removed);
- breast cancer within the previous 20 years;
- allergy to bisphosphonates;
- previous treatment with a bisphosphonate or other drugs affecting bone metabolism within the last 6 months;
- inability to stand or sit upright for 60 minutes.
Gender: Females
Age limits: Min: 47 Years Max: 80 Years
Accepts healthy volunteers: No
Trial registration date: 05/04/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
China
- Beijing
- Changsha
- Guangzhou
- Hong Kong
- Nanjing
- Shanghai
