IMPACT Study (Improving Measurements of Persistence on "ACtonel" Treatment)

January 10, 2011 updated by: Sanofi

A Multicenter Prospective Study to Assess the Impact of Physician's Reinforcement on the Subject's Compliance and Persistence on Treatment Using Feedback on Bone Markers in Previously Undiagnosed Postmenopausal Osteoporotic Women Treated With Risedronate.

The primary objective of this study is to assess the impact of physician's reinforcement using bone marker data on the subject's compliance (at least 50% drug taken) and persistence on treatment after one year in postmenopausal osteoporotic women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Ambulatory women,
  • Caucasian, Oriental or Multiracial
  • not previously diagnosed for osteoporosis.

Exclusion Criteria:

  • Females of black descent and for the US african american are excluded because of the very low incidence of postmenopausal osteoporosis
  • and having used oral or parenteral glucocorticoids (>= 5 mg prednisone or equivalent per day) within 3 months of starting study drug or for more than one month within six months prior to study entry.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the impact of physician's reinforcement using bone marker data on the treatment adherence of women with PMO.
Time Frame: collected at week 10 and 22
collected at week 10 and 22

Secondary Outcome Measures

Outcome Measure
Time Frame
to establish the profile of the unrecognized osteoporotic woman (PVD-, RF-) using a risk factor questionnaire for osteoporosis
Time Frame: During the study conduct
During the study conduct
to assess the decrease of type I collagen breakdown products(urinary NTX and serum CTX)
Time Frame: after 10 and 22 weeks of treatment
after 10 and 22 weeks of treatment
To assess the change in BMD of both total hip and lumbar spine;
Time Frame: at week 52 compared to baseline
at week 52 compared to baseline
osteoporosis-related genotyping.
Time Frame: During the study conduct
During the study conduct

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Procter and Gamble

Investigators

  • Study Director: Lex van de Langerijt, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1999

Primary Completion (Actual)

February 1, 2002

Study Registration Dates

First Submitted

December 21, 2005

First Submitted That Met QC Criteria

December 21, 2005

First Posted (Estimate)

December 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMR4003B_4001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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