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Trial information
A Study of Boniva (Ibandronate) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Post-Menopausal Osteoporosis
Status: Completed
Protocol number: ML18057
Sponsor: Roche Laboratories Inc.
Company division: Pharmaceutical
Official Scientific Title: A prospective open-label study to evaluate the change in bone turnover markers, and the effect of an early response on predictivity of response, after once-monthly oral Boniva therapy in treatment-naive postmenopausal osteoporosis patients
Brief summary: This study will evaluate whether an early positive response to once-monthly oral Bonviva in treatment-naive patients with post-menopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is 389.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Post-Menopausal Osteoporosis
Intervention type: Drug
Intervention name: ibandronate[Bonviva/Boniva]
Primary outcome: 1. Percent change from baseline at 6 months by measurement of serum CTX and other bone turnover markers
Key secondary outcomes: 1. Absolute change from baseline to 6 months in bone turnover markers; confidence intervals of relative mean BMD changes; adverse events, including fractures; safety laboratory blood tests; patient confidence level
Inclusion criteria: - women newly diagnosed with postmenopausal osteoporosis;
- no prior bisphosphonate therapy.
Exclusion criteria: - inability to stand or sit upright for >=60 minutes;
- inability to swallow a tablet whole;
- hypersensitivity to any component of Boniva;
- hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months;
- other osteoporosis drug within last 3 months;
- malignant disease diagnosed within previous 10 years (except resected basal cell cancer).
Gender: Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/30/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:United States - Montgomery, AL
- Chandler, AZ
- Peoria, AZ
- Hot Springs, AR
- Pine Bluff, AR
- Anaheim, CA
- Beverly Hills, CA
- Carmichael, CA
- Wilmington, DE
- Deland, FL
- Miami, FL
- Palm Harbor, FL
- Palm Springs, FL
- West Palm Beach, FL
- Atlanta, GA
- Rome, GA
- Morton Grove, IL
- Indianapolis , IN
- Baltimore, MD
- Hagerstown, MD
- Olive Branch, MS
- Jefferson City, MO
- Omaha, NE
- Bronx, NY
- Morehead City, NC
- Raleigh, NC
- Oklahoma City, OK
- Medford, OR
- Doylestown, PA
- Philadelphia, PA
- Ponce, PR
- San Juan, PR
- Santurce, PR
- Murfreesboro, TN
- Amarillo, TX
- Fort Worth, TX
- San Antonio, TX
- Richmond, VA
- Tacoma, WA
- Madison, WI
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