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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:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00577850
First received: December 19, 2007
Last updated: April 15, 2013
Last verified: April 2013
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   40 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00577850     History of Changes
Other Study ID Numbers: 2002095
Study First Received: December 19, 2007
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Alendronate
Etidronic Acid
Risedronic acid
Bone Density Conservation Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014