PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia
NCT02598453 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 545
Last updated 2016-11-02
Summary
The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 individuals.
Conditions
- Postmenopausal Osteoporosis
Interventions
- DRUG
-
Ibandronate
Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-01-31
- Primary Completion
- 2006-09-30
- Completion
- 2006-09-30
Countries
- United States
Study Locations
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