PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia
| Status: | Completed |
|---|---|
| Conditions: | Osteoporosis, Osteoporosis, Postmenopausal Syndrome, Gastrointestinal |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Rheumatology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/3/2016 |
| Start Date: | January 2005 |
| End Date: | September 2006 |
An Open-Label, Multi-Center Study to Determine Level of Adherence to Monthly Oral or Every Three Month Intravenous Ibandronate Treatment in Post-Menopausal Women With Osteoporosis or Osteopenia, Who Are GI Intolerant of Daily or Weekly Alendronate or Risendronate
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.
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.
Inclusion Criteria:
- Women with postmenopausal osteoporosis or osteopenia
- Discontinuation of daily and /or weekly alendronate or risedronate therapy because of
GI intolerance (eg, heartburn, acid reflux, stomach upset)
Exclusion Criteria:
- Inability to stand or sit upright for 60 minutes
- Inability to swallow a tablet whole - Hypersensitivity to any component of Boniva
- Malignant disease diagnosed within previous 10 years (except resected basal cell
cancer); contraindications for calcium or vitamin D therapy
- Patients who do not fulfill a minimum 3 months wash-out therapy from any previous
bisphosphonate therapy
We found this trial at
56
sites
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