A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
| Status: | Completed |
|---|---|
| Conditions: | Osteoporosis, Osteoporosis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2004 |
| End Date: | May 2006 |
A Prospective Open-Label, Multicenter Study to Evaluate the Change in Bone Turnover Markers After Once Monthly Oral Ibandronate Therapy in Treatment Naive Postmenopausal Osteoporosis Patients
This study will evaluate whether an early positive response to once-monthly oral ibandronate
in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy
later in treatment. The anticipated time on study treatment is 6 months, and the target
sample size is 360 individuals.
in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy
later in treatment. The anticipated time on study treatment is 6 months, and the target
sample size is 360 individuals.
Inclusion Criteria:
- Women newly diagnosed with postmenopausal osteoporosis
- Naive to prior bisphosphonate therapy
Exclusion Criteria:
- Inability to stand or sit upright for at least 60 minutes
- Inability to swallow a tablet whole
- Hypersensitivity to any component of ibandronate
- 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
We found this trial at
50
sites
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