Trial information
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.
Status: No longer recruiting
Protocol number: ML19357
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study of the effect of oral monthly Bonviva on in vivo bone micro-architecture parameters in post-menopausal women with osteopenia
Brief summary: This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals. Target sample size is
150.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Post-Menopausal Osteopenia
Intervention type: Drug
Intervention name: ibandronate [Bonviva/Boniva]
Primary outcome: 1. Trabecular BV/TV at distal radius of non-dominant arm Time frame: 12 arms
Key secondary outcomes: 1. Trabecular BV/TV at distal radius of non-dominant arm Time frame: 6 months and 2 years
2. Bone density, trabecular BV/TV at distal tibia Time frame: 6 months, 1 and 2 years
3. Serum CTX Time frame: Intervals throughout study
4. Lumbar hip and wrist BMD Time frame: 1 and 2 years
5. AEs and laboratory parameters Time frame: Throughout study
Inclusion criteria:
- post-menopausal women, aged 55-75 years;
- diagnosed osteopenia.
Exclusion criteria:
- history of osteoporotic vertebral fracture;
- contraindication to ibandronate.
Gender: Females
Age limits: Min: 55 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: January, 2007
Trial registration date: 07/19/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
France
- Lyon
- Paris
- Saint-Etienne
- Toulouse
