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
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