Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose

Completed · Phase 1

Conditions studied: Osteopenia, Osteoporosis

In brief

The primary objective of this study is to compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.

Key facts

Study ID

NCT00577850

Run by

Warner Chilcott

People needed

32

Starts

2002-11-01

Expected to finish

2004-02-01

Last updated by the study team

2013-04-17

Who can join

Age: 40 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Facility — Gainesville, Florida, United States
• Research Site — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.