Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose
Information source: Warner Chilcott
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteopenia; Osteoporosis
Intervention: risedronate (Drug); alendronate (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Warner Chilcott Official(s) and/or principal investigator(s):
Amy Sun, MD, PhD, Study Director, Affiliation: Procter and Gamble
Summary
The primary objective of this study is to compare the urinary excretion of 14C-labeled
risedronate and alendronate over 28 days.
Clinical Details
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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
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.
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Research Facility, Gainesville, Florida, United States
Research Site, New Orleans, Louisiana, United States
Additional Information
Starting date: November 2002
Last updated: April 15, 2013
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