Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00577720
First received: December 19, 2007
Last updated: December 6, 2011
Last verified: November 2011
History of Changes

December 19, 2007
December 6, 2011
July 2006
January 2007   (final data collection date for primary outcome measure)
Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
Efficacy, based on the bone turnover marker of a delayed-release risedronate tablet, administered immediately after a typical breakfast, to that of an immediate-release tablet, administered according to labeling instructions in postmenopausal women. [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00577720 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate
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

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Postmenopausal Women
  • Drug: risedronate
    35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks
  • Drug: risedronate
    35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
  • Drug: risedronate
    50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
  • Drug: risedronate
    50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks
  • Active Comparator: 35 mg IRBB
    35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
    Intervention: Drug: risedronate
  • Experimental: 35 mg DRFB
    35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
    Intervention: Drug: risedronate
  • Experimental: 50 mg DRFB
    50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
    Intervention: Drug: risedronate
  • Experimental: 50 mg DRBB
    50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
    Intervention: Drug: risedronate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
January 2007
January 2007   (final data collection date for primary outcome measure)

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
Female
45 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00577720
2005107
No
Warner Chilcott
Warner Chilcott
Not Provided
Study Director: Lu A Sun, MD, PhD Procter and Gamble
Warner Chilcott
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP