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Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate

Information source: Warner Chilcott
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: risedronate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Warner Chilcott

Official(s) and/or principal investigator(s):
Ana M Balske, MD, Study Director, Affiliation: Procter and Gamble

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.

Clinical Details

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

Study design: N/A

Primary outcome: Differences in iliac crest bone histomorphometry and bone quality in patients receiving risedronate

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Maria Greenwald, MD, Palm Desert, California 92260, United States

Paul Miller, MD, Lakewood, Colorado 80227, United States

Grattan Woodson, MD, Decatur, Georgia 30033, United States

Christopher Recknor, MD, Gainesville, Georgia 30501, United States

Robert Recker, MD, Omaha, Nebraska 68131, United States

Nelson Watts, MD, Cincinnati, Ohio 45219, United States

Ronald D Emkey, MD, Wyomissing, Pennsylvania 19610, United States

Louis-Georges Ste-Marie, MD, Montreal, Quebec H2X 1P1, Canada

Additional Information

Starting date: April 2003
Last updated: June 3, 2013

Page last updated: August 20, 2015

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