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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00577850
• Other study ID #: 2002095
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2007
• Last updated: April 15, 2013
• Start date: November 2002
• Est. completion date: February 2004

Study information

• Verified date: April 2013
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Research Facility	Gainesville	Florida
United States	Research Site	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Warner Chilcott	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.		28 days	Yes
Secondary	to compare urinary excretion and serum concentration-time profiles of 14C-labeled risedronate and alendronate over 52 weeks.		52 weeks	Yes