Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Louis-Georges Ste-Marie, MD, Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

risedronate

Drug

risedronate tablet, 5 mg daily or 35 mg once weekly for 5 years

Primary outcomes

Differences in iliac crest bone histomorphometry and bone quality in patients receiving risedronate

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Collaborators

Sanofi

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2006
Study completion: 2006
First posted: Feb 5, 2009
Registry last updated: Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed