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OpenTrials
Completed

NCT Number: NCT00577850

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

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

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Key information

Conditions

Osteopenia Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Research Facility, Gainesville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

risedronate

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

Alendronate

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

Primary outcomes

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

    Time frame: 28 days

Secondary outcomes

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

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Collaborators

  • Sanofi

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Dec 20, 2007
Registry last updated
Apr 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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