Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose
Overview
The primary objective of this study is to compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.
Full Title of Study: “Study to Determine the Pharmacokinetics of a Single 14C-labeled Intravenous Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose to Postmenopausal Women With Osteopenia or Osteoporosis”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Study Primary Completion Date: February 2004
Interventions
- Drug: risedronate
- 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
- Drug: alendronate
- 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
Arms, Groups and Cohorts
- Experimental: 1
- 0.23 mg 14C-labeled risedronate, followed 7 days later with oral 35 mg risedronate once a week for 52 weeks
- Active Comparator: 2
- 0.45 mg 14C-labeled alendronate, followed 7 days later with oral 70 mg of alendronate once a week for 52 weeks
Clinical Trial Outcome Measures
Primary Measures
- compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.
- Time Frame: 28 days
Secondary Measures
- to compare urinary excretion and serum concentration-time profiles of 14C-labeled risedronate and alendronate over 52 weeks.
- Time Frame: 52 weeks
Participating in This Clinical Trial
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
Gender Eligibility: Female
Minimum Age: 40 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Warner Chilcott
- Collaborator
- Sanofi
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Amy Sun, MD, PhD, Study Director, Procter and Gamble
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