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Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate

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ClinicalTrials.gov Identifier: NCT00837746
Recruitment Status : Completed
First Posted : February 5, 2009
Last Update Posted : June 5, 2013
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott

Brief Summary:
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.

Condition or disease Intervention/treatment
Osteoporosis Drug: risedronate

Study Type : Observational
Actual Enrollment : 29 participants
Official Title: Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Risedronate Daily or Weekly
Study Start Date : April 2003
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Differences in iliac crest bone histomorphometry and bone quality in patients receiving risedronate [ Time Frame: 5 years ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837746


Locations
United States, California
Maria Greenwald, MD
Palm Desert, California, United States, 92260
United States, Colorado
Paul Miller, MD
Lakewood, Colorado, United States, 80227
United States, Georgia
Grattan Woodson, MD
Decatur, Georgia, United States, 30033
Christopher Recknor, MD
Gainesville, Georgia, United States, 30501
United States, Nebraska
Robert Recker, MD
Omaha, Nebraska, United States, 68131
United States, Ohio
Nelson Watts, MD
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Ronald D Emkey, MD
Wyomissing, Pennsylvania, United States, 19610
Canada, Quebec
Louis-Georges Ste-Marie, MD
Montreal, Quebec, Canada, H2X 1P1
Sponsors and Collaborators
Warner Chilcott
Sanofi
Investigators
Study Director: Ana M Balske, MD Procter and Gamble

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00837746     History of Changes
Other Study ID Numbers: 2004140
First Posted: February 5, 2009    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Risedronate Sodium
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs