IMPACT Study (Improving Measurements of Persistence on "ACtonel" Treatment)
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.
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 21, 2005
CompletedFirst Posted
Study publicly available on registry
December 22, 2005
CompletedJanuary 11, 2011
January 1, 2011
2.5 years
December 21, 2005
January 10, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the impact of physician's reinforcement using bone marker data on the treatment adherence of women with PMO.
collected at week 10 and 22
Secondary Outcomes (4)
to establish the profile of the unrecognized osteoporotic woman (PVD-, RF-) using a risk factor questionnaire for osteoporosis
During the study conduct
to assess the decrease of type I collagen breakdown products(urinary NTX and serum CTX)
after 10 and 22 weeks of treatment
To assess the change in BMD of both total hip and lumbar spine;
at week 52 compared to baseline
osteoporosis-related genotyping.
During the study conduct
Interventions
Eligibility Criteria
You may qualify if:
- Ambulatory women,
- Caucasian, Oriental or Multiracial
- not previously diagnosed for osteoporosis.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Procter and Gamblecollaborator
Related Publications (1)
Delmas PD, Vrijens B, Eastell R, Roux C, Pols HA, Ringe JD, Grauer A, Cahall D, Watts NB; Improving Measurements of Persistence on Actonel Treatment (IMPACT) Investigators. Effect of monitoring bone turnover markers on persistence with risedronate treatment of postmenopausal osteoporosis. J Clin Endocrinol Metab. 2007 Apr;92(4):1296-304. doi: 10.1210/jc.2006-1526. Epub 2007 Jan 23.
PMID: 17244788RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lex van de Langerijt
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 21, 2005
First Posted
December 22, 2005
Study Start
August 1, 1999
Primary Completion
February 1, 2002
Last Updated
January 11, 2011
Record last verified: 2011-01