Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837746
• Other study ID #: 2004140
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2009
• Last updated: June 3, 2013
• Start date: April 2003
• Est. completion date: October 2006

Study information

• Verified date: June 2013
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
Canada	Louis-Georges Ste-Marie, MD	Montreal	Quebec
United States	Nelson Watts, MD	Cincinnati	Ohio
United States	Grattan Woodson, MD	Decatur	Georgia
United States	Christopher Recknor, MD	Gainesville	Georgia
United States	Paul Miller, MD	Lakewood	Colorado
United States	Robert Recker, MD	Omaha	Nebraska
United States	Maria Greenwald, MD	Palm Desert	California
United States	Ronald D Emkey, MD	Wyomissing	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Warner Chilcott	Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in iliac crest bone histomorphometry and bone quality in patients receiving risedronate		5 years	No