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Trial information
A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
Status: Completed
Protocol number: MA19547
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: Randomized, open-label, multi-center study to investigate patient preference on dosing in women with postmenopausal osteoporosis treated with once monthly ibandronate and once weekly risedronate. A six month, two-sequence and two-period crossover study.
Brief summary: This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 356.
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 monthly dosing with Bonviva over weekly dosing with risedronate Time frame: 6 months
Key secondary outcomes: 1. Convenience of monthly Bonviva over weekly risedronate Time frame: 6 months
2. Change in serum CTX Time frame: 12 weeks/3 months
3. Upper gastrointestinal symptoms Time frame: 12 weeks/3 months
4. AEs and laboratory parameters Time frame: Throughout study
Inclusion criteria: - ambulatory women with post-menopausal osteoporosis;
- patients who are bisphosphonate-naive, or who have previously received oral daily or i.v. bisphosphonate therapy (fulfilling certain criteria detailed in the protocol).
Exclusion criteria: - malignant disease diagnosed within previous 10 years (except for successfully resected basal cell cancer;) breast cancer within previous 20 years;
- inability to stand or sit upright for at least 60 minutes;
- disease/disorder/treatment with drugs known to influence bone metabolism.
Gender: Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2006
Trial registration date: 09/18/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:United States - Birmingham, AL
- Mesa, AZ
- Scottsdale, AZ
- Jonesboro, AR
- Anaheim, CA
- San Diego , CA
- Waterbury, CT
- Boynton Beach, FL
- Jupiter, FL
- Leesburg, FL
- Merritt Island, FL
- Ocala, FL
- Pembroke Pines, FL
- Spring Hill, FL
- St Petersburg, FL
- Tampa, FL
- West Palm Beach, FL
- Douglasville, GA
- Gainesville, GA
- Marietta, GA
- Madisonville, KY
- Bethesda, MD
- Missoula, MT
- Omaha, NE
- Morehead City, NC
- New Bern, NC
- Jamestown, ND
- Cincinnati, OH
- Mogadore, OH
- Duncansville, PA
- Feasterville, PA
- Philadelphia, PA
- Selmer, TN
- Bedford, TX
- Bryan, TX
- Houston, TX
- Richmond, VA
- Seattle, WA
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