NCT00577850

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Osteopenia
• Osteoporosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2002-11-01
• Primary completion: 2004-02-01
• Completion: 2004-02-01
• First posted: 2007-12-20
• Last updated: 2013-04-17

Locations

2 sites across 1 country: United States