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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
  Purpose

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.


Condition Intervention Phase
Postmenopausal Women
 Drug: risedronate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 181
Study Start Date: July 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 35 mg IRBB
35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
 Drug: risedronate
35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks
Experimental: 35 mg DRFB
35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
 Drug: risedronate
35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
Experimental: 50 mg DRFB
50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
 Drug: risedronate
50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
Experimental: 50 mg DRBB
50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
 Drug: risedronate
50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577720

Locations
United States, California
Research Facility
Costa Mesa, California, United States, 92626
United States, Florida
Research Facility
Gainsville, Florida, United States, 32608
Research Facility
Miami, Florida, United States, 33126
United States, Hawaii
Research Facility
Honolulu, Hawaii, United States, 86813
United States, Texas
Research Site
Dallas, Texas, United States, 75247
Research Facility
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Lu A Sun, MD, PhD Procter and Gamble
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00577720     History of Changes
Other Study ID Numbers: 2005107
Study First Received: December 19, 2007
Results First Received: August 12, 2011
Last Updated: December 6, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013