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

Sponsor

Warner Chilcott (Industry)

Overall Status

Completed

CT.gov ID

NCT00577850

Collaborator

Sanofi (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteopenia Osteoporosis	Drug: risedronate Drug: alendronate	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

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

Study Start Date :

Nov 1, 2002

Actual Primary Completion Date :

Feb 1, 2004

Actual Study Completion Date :

Feb 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 0.23 mg 14C-labeled risedronate, followed 7 days later with oral 35 mg risedronate once a week for 52 weeks	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
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	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

Arm

Intervention/Treatment

Experimental: 1

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

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

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

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

Outcome Measures

Primary Outcome Measures

compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days. [28 days]

Secondary Outcome Measures

to compare urinary excretion and serum concentration-time profiles of 14C-labeled risedronate and alendronate over 52 weeks. [52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Facility	Gainesville	Florida	United States
2	Research Site	New Orleans	Louisiana	United States

Sponsors and Collaborators

Warner Chilcott
Sanofi

Investigators

Study Director: Amy Sun, MD, PhD, Procter and Gamble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Warner Chilcott

ClinicalTrials.gov Identifier:

NCT00577850

Other Study ID Numbers:

2002095

First Posted:

Dec 20, 2007

Last Update Posted:

Apr 17, 2013

Last Verified:

Apr 1, 2013

Additional relevant MeSH terms:

Osteoporosis

Bone Diseases, Metabolic

Alendronate

Risedronic Acid

Study Results

No Results Posted as of Apr 17, 2013