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

Osteoporosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268632
• Other study ID #: HMR4003B_4001
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2005
• Last updated: January 10, 2011
• Start date: August 1999

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• risedronate

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Procter and Gamble

References & 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 treatme — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	to establish the profile of the unrecognized osteoporotic woman (PVD-, RF-) using a risk factor questionnaire for osteoporosis		During the study conduct	No
Secondary	to assess the decrease of type I collagen breakdown products(urinary NTX and serum CTX)		after 10 and 22 weeks of treatment	No
Secondary	To assess the change in BMD of both total hip and lumbar spine;		at week 52 compared to baseline	No
Secondary	osteoporosis-related genotyping.		During the study conduct	No

External Links

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