We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00268632
First Posted: December 22, 2005
Last Update Posted: January 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Procter and Gamble
Information provided by:
Sanofi
  Purpose
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.

Condition Intervention Phase
Osteoporosis Drug: risedronate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • to establish the profile of the unrecognized osteoporotic woman (PVD-, RF-) using a risk factor questionnaire for osteoporosis [ Time Frame: 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 ]
  • To assess the change in BMD of both total hip and lumbar spine; [ Time Frame: at week 52 compared to baseline ]
  • osteoporosis-related genotyping. [ Time Frame: During the study conduct ]

Study Start Date: August 1999
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268632


Sponsors and Collaborators
Sanofi
Procter and Gamble
Investigators
Study Director: Lex van de Langerijt Sanofi
  More Information

Additional Information:
Publications:
Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00268632     History of Changes
Other Study ID Numbers: HMR4003B_4001
First Submitted: December 21, 2005
First Posted: December 22, 2005
Last Update Posted: January 11, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Risedronate Sodium
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs