Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00837746
First received: February 3, 2009
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Osteoporosis
Drug: risedronate
Phase 4

Study Type: Observational
Official Title: Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Risedronate Daily or Weekly

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Differences in iliac crest bone histomorphometry and bone quality in patients receiving risedronate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: April 2003
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Women taking risedronate for 5 years
Drug: risedronate
risedronate tablet, 5 mg daily or 35 mg once weekly for 5 years

  Eligibility

Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00837746     History of Changes
Other Study ID Numbers: 2004140
Study First Received: February 3, 2009
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Etidronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014