search
Back to results

Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate

Primary Purpose

Osteoporosis

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
risedronate
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Osteoporosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Maria Greenwald, MD
  • Paul Miller, MD
  • Grattan Woodson, MD
  • Christopher Recknor, MD
  • Robert Recker, MD
  • Nelson Watts, MD
  • Ronald D Emkey, MD
  • Louis-Georges Ste-Marie, MD

Arms of the Study

Arm 1

Arm Type

Arm Label

1

Arm Description

Women taking risedronate for 5 years

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 3, 2009
Last Updated
June 3, 2013
Sponsor
Warner Chilcott
Collaborators
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT00837746
Brief Title
Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate
Official Title
Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Risedronate Daily or Weekly
Study Type
Observational

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Description
Women taking risedronate for 5 years
Intervention Type
Drug
Intervention Name(s)
risedronate
Intervention Description
risedronate tablet, 5 mg daily or 35 mg once weekly for 5 years
Primary Outcome Measure Information:
Title
Differences in iliac crest bone histomorphometry and bone quality in patients receiving risedronate
Time Frame
5 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana M Balske, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Maria Greenwald, MD
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Paul Miller, MD
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80227
Country
United States
Facility Name
Grattan Woodson, MD
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Christopher Recknor, MD
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Robert Recker, MD
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Nelson Watts, MD
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ronald D Emkey, MD
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Louis-Georges Ste-Marie, MD
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1P1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate

We'll reach out to this number within 24 hrs