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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00268632

Enrollment

Unknown

Registered

2005-12-22

Start date

1999-08-31

Completion date

Unknown

Last updated

2011-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

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.

Interventions

DRUGrisedronate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

65 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026