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Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT00577850•Warner Chilcott

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

40 - 75 years

Sex

FEMALE

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

Locations (2)

Research Facility

Gainesville, Florida, United States

Research Site

New Orleans, Louisiana, United States

Key Dates

Start Date

November 1, 2002

Primary Completion Date

February 1, 2004

Completion Date

February 1, 2004

Last Updated

April 17, 2013

Enrollment

ACTUAL participants

Conditions

OsteopeniaOsteoporosis

Interventions

risedronate

DRUG

alendronate

DRUG

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

NCT06731608

OsteoporosisLower Limb Fracture

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RECRUITINGPHASE4

Step-down Therapy After Long-term Osteoporosis Treatment

NCT07281586

Osteoporosis

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RECRUITING

Smart Wearable Device (gaitQ): Walk Better Project

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Step-down Therapy After Long-term Osteoporosis Treatment

Smart Wearable Device (gaitQ): Walk Better Project

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