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

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00268632
First received: December 21, 2005
Last updated: January 10, 2011
Last verified: January 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • to assess the decrease of type I collagen breakdown products(urinary NTX and serum CTX) [ Time Frame: after 10 and 22 weeks of treatment ] [ Designated as safety issue: No ]
  • To assess the change in BMD of both total hip and lumbar spine; [ Time Frame: at week 52 compared to baseline ] [ Designated as safety issue: No ]
  • osteoporosis-related genotyping. [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   65 Years to 80 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 21, 2005
Last Updated: January 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014