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OpenTrials
Completed

NCT Number: NCT00577720

Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate

To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.

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Key information

Conditions

Postmenopausal Women

Age range

45 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Facility, Costa Mesa, California, United States

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About this study

To compare the efficacy, based on the bone turnover marker (BTM) serum Type I collagen C-telopeptide (CTx), of a 50 mg delayed-release risedronate tablet, administered immediately after a typical breakfast, to that of a 35 mg immediate-release tablet, administered according to labeling instructions (ie, at least 30 minutes prior to breakfast) in postmenopausal women after 13 weeks of treatment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • In generally good health, as determined by medical history, physical examination, and laboratory test results
  • Postmenopausal greater than 2 years, naturally or surgically based on medical history.

Exclusion criteria

  • Used any of the following medications within 3 months prior to dosing or used any of the following medications for more than 1 month at any time within 6 months prior to dosing:
  • oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day)
  • anabolic steroids
  • estrogens (oral, skin patch, or gel), except for low dose vaginal products or insertable estrogen ring, selective estrogen-receptor modulators, or estrogen-related drugs
  • progestins
  • calcitonin
  • vitamin D supplements
  • calcitriol, calcidiol, or alfacalcidol at any dose
  • any bisphosphonate
  • fluoride
  • strontium
  • parathyroid hormone, including teriparatide

Treatment and study plan

risedronate

Drug

35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks

Primary outcomes

  1. Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population

    Time frame: Baseline and Week 13

Secondary outcomes

  1. Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population

    Time frame: Baseline and Week 13

  2. Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population

    Time frame: Baseline and Week 13

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study title

Study to Assess the Efficacy, Safety and Pharmacokinetics of Risedronate Upon Oral Administration of a 35 mg Delayed-Release, a 50 mg Delayed-Release or a 35 mg Immediate-Release Administered Weekly for 13 Weeks to Postmenopausal Women

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 20, 2007
Registry last updated
Jan 13, 2012

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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