Back to resultsIMPACT Study (Improving Measurements of Persistence on "ACtonel" Treatment)
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
risedronate
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
To assess the impact of physician's reinforcement using bone marker data on the treatment adherence of women with PMO.
Secondary Outcome Measures
to establish the profile of the unrecognized osteoporotic woman (PVD-, RF-) using a risk factor questionnaire for osteoporosis
to assess the decrease of type I collagen breakdown products(urinary NTX and serum CTX)
To assess the change in BMD of both total hip and lumbar spine;
osteoporosis-related genotyping.
Full Information
NCT ID
NCT00268632
First Posted
December 21, 2005
Last Updated
January 10, 2011
Sponsor
Sanofi
Collaborators
Procter and Gamble
1. Study Identification
Unique Protocol Identification Number
NCT00268632
Brief Title
IMPACT Study (Improving Measurements of Persistence on "ACtonel" 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 Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
Collaborators
Procter and Gamble
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
risedronate
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
to establish the profile of the unrecognized osteoporotic woman (PVD-, RF-) using a risk factor questionnaire for osteoporosis
Time Frame
During the study conduct
Title
to assess the decrease of type I collagen breakdown products(urinary NTX and serum CTX)
Time Frame
after 10 and 22 weeks of treatment
Title
To assess the change in BMD of both total hip and lumbar spine;
Time Frame
at week 52 compared to baseline
Title
osteoporosis-related genotyping.
Time Frame
During the study conduct
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lex van de Langerijt
Organizational Affiliation
Sanofi
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17244788
Citation
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. Erratum In: J Clin Endocrinol Metab. 2007 Jun;92(6):2285.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17244788&query_hl=2&itool=pubmed_docsum
Description
Related Info
Learn more about this trial
IMPACT Study (Improving Measurements of Persistence on "ACtonel" Treatment)
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