Working… Menu

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

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. Identifier: NCT00268632
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : January 11, 2011
Procter and Gamble
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoporosis Drug: risedronate Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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.
Study Start Date : August 1999
Actual Primary Completion Date : February 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Primary Outcome Measures :
  1. 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 :
  1. to establish the profile of the unrecognized osteoporotic woman (PVD-, RF-) using a risk factor questionnaire for osteoporosis [ Time Frame: During the study conduct ]
  2. to assess the decrease of type I collagen breakdown products(urinary NTX and serum CTX) [ Time Frame: after 10 and 22 weeks of treatment ]
  3. To assess the change in BMD of both total hip and lumbar spine; [ Time Frame: at week 52 compared to baseline ]
  4. osteoporosis-related genotyping. [ Time Frame: During the study conduct ]

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.

Layout table for eligibility information
Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00268632

Sponsors and Collaborators
Procter and Gamble
Layout table for investigator information
Study Director: Lex van de Langerijt Sanofi

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00268632     History of Changes
Other Study ID Numbers: HMR4003B_4001
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Risedronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents