Osteopenia, Osteoporosis
Conditions
Brief summary
The primary objective of this study is to compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.
Interventions
DRUGrisedronate
0.23 mg 14C-labeled risedronate, followed 7 days later with oral 35 mg risedronate once a week for 52 weeks followed by another 14C-labeled risedronate followed weekly by 35 mg risedronate for 3 weeks
DRUGalendronate
0.45 mg 14C-labeled alendronate, followed 7 days later with oral 705 mg alendronate once a week for 52 weeks followed by another 14C-labeled alendronate followed weekly by 70 mg alendronate for 3 weeks
Sponsors
Sanofi
Warner Chilcott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* have medical history documentation verifying postmenopausal status of at least 2 years (natural or surgical). If not documented, confirmation will be required using estradiol \< 20 pg/mL and follicle stimulating hormone (FSH) \> 40 IU/mL; * have osteopenia or osteoporosis (\< 1.002 g/cm2 Lunar or \< 0.882 g/cm2 Hologic) as determined by DXA of the lumbar spine (AP or PA view, L1-L4). This corresponds to a T-score of approximately \< -1.5.
Exclusion criteria
* any clinically significant out-of-range laboratory values and vital signs, * a clinically significant cardiovascular, hepatic, renal, or parathyroid disease, in the opinion of the Investigator * a known hypersensitivity to bisphosphonates
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days. | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| to compare urinary excretion and serum concentration-time profiles of 14C-labeled risedronate and alendronate over 52 weeks. | 52 weeks |
Countries
United States
Outcome results
None listed