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

NCT ID: NCT00577850

Last Updated: 2013-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2004-02-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

1

0.23 mg 14C-labeled risedronate, followed 7 days later with oral 35 mg risedronate once a week for 52 weeks

Group Type: EXPERIMENTAL

risedronate

Intervention Type: DRUG

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

2

0.45 mg 14C-labeled alendronate, followed 7 days later with oral 70 mg of alendronate once a week for 52 weeks

Group Type: ACTIVE_COMPARATOR

alendronate

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Warner Chilcott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Sun, MD, PhD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

Research Facility

Gainesville, Florida, United States

Research Site

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

2002095

Identifier Type: -

Identifier Source: org_study_id