ROSPA - Record on Satisfaction of Patients With Actonel 35 mg Once a Week

To determine the satisfaction of subject with Actonel 35 mg Once a Week in the treatment of post-menopausal osteoporosis. Open, non-controlled, multi-center study...

Date First Received: October 15, 2007

Last Updated: May 27, 2008

Verified by: Sanofi-Aventis, May 2008

Clinical Trial Phase: Phase 4 | Start Date: May 2005

Overall Status: Terminated

Estimated Enrollment: 7

Brief Summary

Official Title: “Record on Satisfaction of Patients With Actonel 35 mg Once a Week”

Condition Keyword(s):

Intervention(s):

To determine the satisfaction of subject with Actonel 35 mg Once a Week in the treatment of post-menopausal osteoporosis. Open, non-controlled, multi-center study.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Study Primary Completion Date: September 2006

Intervention(s) in this Clinical Trial

  • Drug: Risedronate

Outcome Measures for this Clinical Trial

Primary Measures

  • Patient satisfaction and compliance
    • Time Frame: During all the study
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion criteria :

  • Postmenopausal ambulatory women
  • Established osteoporosis

Exclusion criteria:

  • History of cancer: basal cell or squamous cell carcinoma-documented 6-month remission,
  • Diagnosis of hypocalcemia, hyperparathyroidism, hyperthyroidism
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Jean-Marc Chantelot, MD Study Director Sanofi-Aventis  

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00544180

Study ID Number: RISED_L_01686

ClinicalTrials.gov Identifier: NCT00544180

Health Authority: Israel: Ministry of Health

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