Trial information
MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
Status: Completed
Protocol number: BM16549
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study comparing the effect of monthly versus daily treatment with oral Bonviva on lumbar bone mineral density in women with osteoporosis
Brief summary: This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.
Target sample size is 1592.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; 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 bone mineral density (BMD)
Time frame: 12 months
Key secondary outcomes: 1. Relative change in mean lumbar spine BMD Time frame: 24 months
2. Relative and absolute change in total hip, trochanter, femoral neck BMD Time frame: 12 and 24 months
3. Percentage of responders Time frame: 12 and 24 months
4. Change from baseline in fasting serum CTX Time frame: 3, 6, 12 and 24 months
5. AEs, laboratory parameters Time frame: Throughout study
Inclusion criteria:
- women 55-80 years of age;
- post-menopausal for >= 5 years;
- ambulatory.
Exclusion criteria:
- malignant disease diagnosed within the 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 an intravenous bisphosphonate at any time;
- previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, or >3 months of treatment within the last 2 years.
Gender: Females
Age limits: Min: 55 Years Max: 80 Years
Accepts healthy volunteers: No
Trial registration date: 06/24/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
Belgium
Brazil
- Campinas
- Curitiba
- Porto Alegre
- Sao Paulo
Canada
- Calgary, AB
- Vancouver, BC
- Toronto, ON
- Quebec City, QC
Czech Republic
Denmark
France
Germany
Hungary
- Balatonfuered
- Budapest
- Kiskunhalas
- Zalaegerszeg
Italy
- Siena
- Valeggio Sul Mincio
Mexico
Norway
Poland
Romania
South Africa
Spain
Switzerland
United Kingdom
- Cardiff
- Liverpool
- London
- Southampton
United States
- Irvine, CA
- Loma Linda, CA
- Los Angeles, CA
- Oakland, CA
- Rancho Mirage, CA
- Lakewood, CO
- Gainesville, FL
- Bethesda, MD
- Wheaton, MD
- St Louis, MO
- Billings, MT
- Omaha, NE
- Livingston, NJ
- Albuquerque, NM
- Portland, OR
- Wyomissing, PA
- San Antonio, TX
- Richmond, VA
- Seattle, WA
- Madison, WI
