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Therapeutic Areas: Obstetrics/Gynecology | Musculoskeletal
Disease Category: Post-Menopausal Osteoporosis
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 Design / Study Details:
- Purpose: Treatment
- Allocation: Non-Randomized
- Masking: Open Label
- Control: Uncontrolled
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
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: Years
Accepts Healthy Volunteers: No
Trial Registration Date: 08/30/2005
Date Last Updated: 12/08/2008
Link To Trial Results
Research Site:
Located In:
Peoria AZ 85381
Phone: 973-235-5000 or 800-526-6367
View Google Map
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