Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate
Completed · Phase 2
Conditions studied: Postmenopausal Women
In brief
To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.
Key facts
- Study ID
- NCT00577720
- Run by
- Warner Chilcott
- People needed
- 181
- Starts
- 2006-07-01
- Expected to finish
- 2007-01-01
- Last updated by the study team
- 2012-01-13
Who can join
Age: 45 and older, up to 80. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- In generally good health, as determined by medical history, physical examination, and laboratory test results
- Postmenopausal greater than 2 years, naturally or surgically based on medical history.
You may not qualify if…
- Used any of the following medications within 3 months prior to dosing or used any of the following medications for more than 1 month at any time within 6 months prior to dosing:
- oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day)
- anabolic steroids
- estrogens (oral, skin patch, or gel), except for low dose vaginal products or insertable estrogen ring, selective estrogen-receptor modulators, or estrogen-related drugs
- progestins
- calcitonin
- vitamin D supplements
- calcitriol, calcidiol, or alfacalcidol at any dose
- any bisphosphonate
- fluoride
- strontium
- parathyroid hormone, including teriparatide
Where it is running
- Research Facility — Costa Mesa, California, United States
- Research Facility — Gainsville, Florida, United States
- Research Facility — Miami, Florida, United States
- Research Facility — Honolulu, Hawaii, United States
- Research Site — Dallas, Texas, United States
- Research Facility — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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