Pharmacokinetics of a Single 14C-Labeled Dose of Risedronate or Alendronate Followed by Once-a-Week Unlabeled Oral Dose
Information source: Procter and Gamble
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteopenia; Osteoporosis
Intervention: risedronate (Drug); alendronate (Drug)
Phase: Phase 1
Sponsored by: Procter and Gamble
Official(s) and/or principal investigator(s):
Amy Sun, MD, PhD, Study Director, Affiliation: Procter and Gamble
The primary objective of this study is to compare the urinary excretion of 14C-labeled
risedronate and alendronate over 28 days.
Official title: 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 design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Primary outcome: compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.
Secondary outcome: to compare urinary excretion and serum concentration-time profiles of 14C-labeled risedronate and alendronate over 52 weeks.
Minimum age: 40 Years.
Maximum age: 75 Years.
- 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.
- 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
Locations and Contacts
Research Facility, Gainesville, Florida, United States
Research Site, New Orleans, Louisiana, United States
Starting date: November 2002
Ending date: February 2004
Last updated: February 11, 2008