NCT00837746

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2003

Typical duration for all trials

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

3.5 years

First QC Date

February 3, 2009

Last Update Submit

June 3, 2013

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

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

    5 years

Study Arms (1)

1

Women taking risedronate for 5 years

Drug: risedronate

Interventions

risedronateDRUG

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

1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Completed month 36 of Study RVN-008993.
  • Underwent an iliac crest bone biopsy at month 36.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Maria Greenwald, MD

Palm Desert, California, 92260, United States

Location

Paul Miller, MD

Lakewood, Colorado, 80227, United States

Location

Grattan Woodson, MD

Decatur, Georgia, 30033, United States

Location

Christopher Recknor, MD

Gainesville, Georgia, 30501, United States

Location

Robert Recker, MD

Omaha, Nebraska, 68131, United States

Location

Nelson Watts, MD

Cincinnati, Ohio, 45219, United States

Location

Ronald D Emkey, MD

Wyomissing, Pennsylvania, 19610, United States

Location

Louis-Georges Ste-Marie, MD

Montreal, Quebec, H2X 1P1, Canada

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ana M Balske, MD

    Procter and Gamble

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 5, 2009

Study Start

April 1, 2003

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

CA(1)US(7)