Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate
This study has been completed.
Sponsor:
Warner Chilcott
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00837746
First received: February 3, 2009
Last updated: April 15, 2013
Last verified: April 2013
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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:
MedlinePlus related topics:
Osteoporosis
Drug Information available for:
Risedronate sodium
U.S. FDA Resources
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: | April 15, 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 May 21, 2013