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”

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

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study

Study Primary Completion Date: February 2004

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 0.23 mg 14C-labeled risedronate, followed 7 days later with oral 35 mg risedronate once a week for 52 weeks
• Active Comparator: 2
  • 0.45 mg 14C-labeled alendronate, followed 7 days later with oral 70 mg of alendronate once a week for 52 weeks

Primary Measures

• compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.
  • Time Frame: 28 days
    Safety Issue?: Yes

Secondary Measures

• to compare urinary excretion and serum concentration-time profiles of 14C-labeled risedronate and alendronate over 52 weeks.
  • Time Frame: 52 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Procter and Gamble

Overall Clinical Trial Officials and Contacts

Amy Sun, MD, PhD Study Director Procter and Gamble  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00577850

Study ID Number: 2002095

ClinicalTrials.gov Identifier: NCT00577850

Health Authority: United States: Food and Drug Administration