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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

Status: Completed

Sponsored by: Procter and Gamble

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: 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.

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
Ending date: February 2004
Last updated: February 11, 2008

Page last updated: June 20, 2008

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