Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate

• Sponsor: Warner Chilcott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00837746
• Collaborator: Sanofi (Industry)
• Enrollment: 29
• Locations: 8
• Duration (Months): 42
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: risedronate

Study Design

• Study Type: Observational
• Actual Enrollment: 29 participants
• Official Title: Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Risedronate Daily or Weekly
• Study Start Date: Apr 1, 2003
• Actual Primary Completion Date: Oct 1, 2006
• Actual Study Completion Date: Oct 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
1 Women taking risedronate for 5 years	Drug: risedronate; risedronate tablet, 5 mg daily or 35 mg once weekly for 5 years

Outcome Measures

Primary Outcome Measures

1. Differences in iliac crest bone histomorphometry and bone quality in patients receiving risedronate [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Maria Greenwald, MD	Palm Desert	California	United States	92260
2	Paul Miller, MD	Lakewood	Colorado	United States	80227
3	Grattan Woodson, MD	Decatur	Georgia	United States	30033
4	Christopher Recknor, MD	Gainesville	Georgia	United States	30501
5	Robert Recker, MD	Omaha	Nebraska	United States	68131
6	Nelson Watts, MD	Cincinnati	Ohio	United States	45219
7	Ronald D Emkey, MD	Wyomissing	Pennsylvania	United States	19610
8	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Warner Chilcott
• ClinicalTrials.gov Identifier: NCT00837746
• Other Study ID Numbers: 2004140
• First Posted: Feb 5, 2009
• Last Update Posted: Jun 5, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Osteoporosis; Risedronic Acid

Study Results

No Results Posted as of Jun 5, 2013