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

December 6, 2011 updated by: Warner Chilcott

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Costa Mesa, California, United States, 92626
        • Research Facility
    • Florida
      • Gainsville, Florida, United States, 32608
        • Research Facility
      • Miami, Florida, United States, 33126
        • Research Facility
    • Hawaii
      • Honolulu, Hawaii, United States, 86813
        • Research Facility
    • Texas
      • Dallas, Texas, United States, 75247
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Experimental: 35 mg DRFB
35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
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
Experimental: 50 mg DRFB
50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
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
Experimental: 50 mg DRBB
50 mg delayed 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population
Time Frame: Baseline and Week 13
Baseline and Week 13

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and Week 13
Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population
Time Frame: Baseline and Week 13
Baseline and Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Warner Chilcott

Investigators

  • Study Director: Lu A Sun, MD, PhD, Procter and Gamble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 19, 2007

First Posted (Estimate)

December 20, 2007

Study Record Updates

Last Update Posted (Estimate)

January 13, 2012

Last Update Submitted That Met QC Criteria

December 6, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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