Trial information
DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
Status: Completed
Protocol number: BM16550
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study comparing the effect of different treatment regimens of intravenous Bonviva on lumbar bone mineral density in women with osteoporosis
Brief summary: This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. 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 1194.
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 fastin 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: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Darlinghurst
- Melbourne
- Nedlands
- St. Leonards
- Sydney
Belgium
Canada
- Toronto, ON
- Laval, QC
- Montreal, QC
- Saskatoon, SK
Czech Republic
Denmark
- Aalborg
- Århus
- Ballerup
- København
- Vejle
France
Germany
Hungary
Italy
- Arenzano
- Siena
- Valeggio Sul Mincio
Mexico
Norway
Poland
South Africa
- Cape Town
- Pretoria
- Sommerset West
Spain
- Barcelona
- Madrid
- Santander
United Kingdom
United States
- Little Rock, AR
- Gainesville, GA
- Bethesda, MD
- St Louis, MO
- Billings, MT
- Omaha, NE
- Albuquerque, NM
- New York, NY
- Bismarck, ND
- Fargo, ND
- Wyomissing, PA
- Rapid City, SD
- San Antonio, TX
- Virginia Beach, VA
- Madison, WI
