Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate

June 3, 2013 updated by: Warner Chilcott

Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Risedronate Daily or Weekly

This study analysed and reported on the study data from three similar, risedronate studies, 1996052, 2003073, and 2003096. The objective of the study was to determine the differences in the iliac crest bone histomorphometry and bone quality in postmenopausal women who had received long term therapy with risedronate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

29

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 1P1
        • Louis-Georges Ste-Marie, MD
  • United States
    • California
      • Palm Desert, California, United States, 92260
        • Maria Greenwald, MD
    • Colorado
      • Lakewood, Colorado, United States, 80227
        • Paul Miller, MD
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Grattan Woodson, MD
      • Gainesville, Georgia, United States, 30501
        • Christopher Recknor, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Robert Recker, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Nelson Watts, MD
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Ronald D Emkey, MD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Completed month 36 of Study RVN-008993.
  • Underwent an iliac crest bone biopsy at month 36.

Exclusion Criteria:

  • Was less than 60% compliant with regard to taking study drug from the start of the study drug to month 24 of study RVN-008993.

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?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Women taking risedronate for 5 years
Drug: risedronate
risedronate tablet, 5 mg daily or 35 mg once weekly for 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in iliac crest bone histomorphometry and bone quality in patients receiving risedronate
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Warner Chilcott

Collaborators

Sanofi

Investigators

  • Study Director: Ana M Balske, MD, 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

April 1, 2003

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

February 4, 2009

First Posted (Estimate)

February 5, 2009

Study Record Updates

Last Update Posted (Estimate)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 3, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004140

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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