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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Procter and Gamble
• Treatments: Risedronate Sodium; Risedronic Acid

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.