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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00577850
First Posted: December 20, 2007
Last Update Posted: April 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
  Purpose
The primary objective of this study is to compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.

Condition Intervention Phase
Osteopenia Osteoporosis Drug: risedronate Drug: alendronate Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days. [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • to compare urinary excretion and serum concentration-time profiles of 14C-labeled risedronate and alendronate over 52 weeks. [ Time Frame: 52 weeks ]

Enrollment: 32
Study Start Date: November 2002
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577850


Locations
United States, Florida
Research Facility
Gainesville, Florida, United States
United States, Louisiana
Research Site
New Orleans, Louisiana, United States
Sponsors and Collaborators
Warner Chilcott
Sanofi
Investigators
Study Director: Amy Sun, MD, PhD Procter and Gamble
  More Information

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00577850     History of Changes
Other Study ID Numbers: 2002095
First Submitted: December 19, 2007
First Posted: December 20, 2007
Last Update Posted: April 17, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alendronate
Risedronate Sodium
Etidronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action