Trial information
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia
Status: Completed
Protocol number: BA18492
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: Double-blind,placebo-controlled,randomized, multicenter study to assess the efficiency and safety of oral ibandronate 150 mg once monthly in postmenopausal women with osteopenia
Brief 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.
Target sample size is
160.
Study phase: IV
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. Relative change in mean lumbar spine bone mineral density (BMD) Time frame: 12 months
Key secondary outcomes: 1. Absolute change in mean lumbar spine BMD Time frame: 12 months
2. Relative and absolute change in mean proximal femur BMD Time frame: 12 months
3. Percentage of responders Time frame: 12 months
4. Relative and absolute change in serum CTX Time frame: 12 months
5. AEs and laboratory parameters Time frame: Throughout study
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.
Gender: Females
Age limits: Min: 45 Years Max: 60 Years
Accepts healthy volunteers: No
Trial registration date: 10/21/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Lakewood, CO
- Bethesda, MD
- Detroit, MI
- St Louis, MO
- Omaha, NE
- Albuquerque, NM
- Cincinnati, OH
- Portland, OR
- Norfolk , VA
- Richmond, VA
