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Trial information
A Study of Bonviva (Ibandronate) in Patients With Post-Menopausal Osteoporosis
Status: Completed
Protocol number: MA17843
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label, muti-center study to investigate patient preference on dosing in women with postmenopausal osteoporosis treated with once-monthly ibandronate and once-weekly alendronate. A six month, two-sequence, and two-period crossover study.
Brief summary: This study will evaluate patient-reported preference for either Bonviva or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 3-6 months, and the target sample size is 100-500 individuals.
Target sample size is
338.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Crossover; Safety/Efficacy study
Condition: Post-Menopausal Osteoporosis
Intervention type: Drug
Intervention name: ibandronate[Bonviva/Boniva]
Primary outcome: 1. Proportion (%) of patients preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate
Key secondary outcomes: 1. Proportion (%) of patients perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate. Explore characteristics of preferred medication.
Safety: Adverse events and laboratory tests
Inclusion criteria: - ambulatory women;
- diagnosis of post-menopausal osteoporosis;
- women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry.
Exclusion criteria: - inability to stand or sit in the upright position for >=60 minutes;
- allergy to bisphosphonates;
- previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry.
Gender: Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/24/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:United States - Huntsville, AL
- Phoenix, AZ
- Tempe, AZ
- Laguna Woods, CA
- Mission Viejo, CA
- Oceanside, CA
- San Diego , CA
- Santa Clarita, CA
- Upland, CA
- Vista, CA
- Denver, CO
- Cromwell, CT
- Waterbury, CT
- Aventura, FL
- Miami, FL
- Pembroke Pines, FL
- Tampa, FL
- West Palm Beach, FL
- Augusta, GA
- Decatur, GA
- Indianapolis , IN
- South Bend, IN
- Des Moines, IA
- Wichita, KS
- Bangor, ME
- Baltimore, MD
- Florissant, MO
- St Louis, MO
- Reno , NV
- Princeton , NJ
- Toms River, NJ
- Raleigh, NC
- Eugene, OR
- Duncansville, PA
- Erie, PA
- Philadelphia, PA
- Wyomissing, PA
- Mount Pleasant, SC
- Nashville, TN
- Houston, TX
- Newport News, VA
- Richmond, VA
- Seattle, WA
- Madison, WI
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