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

This study has been terminated.
(The trial was terminated due to lack of compliance with GCP regulations.)
Procter and Gamble
Information provided by:
Sanofi Identifier:
First received: October 15, 2007
Last updated: September 24, 2009
Last verified: September 2009
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.

Condition Intervention Phase
Drug: Risedronate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Record on Satisfaction of Patients With Actonel 35 mg Once a Week

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Patient satisfaction and compliance [ Time Frame: During all the study ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: May 2005
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00544180

Natanya, Israel
Sponsors and Collaborators
Procter and Gamble
Study Director: Jean-Marc Chantelot, MD Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00544180     History of Changes
Other Study ID Numbers: RISED_L_01686
Study First Received: October 15, 2007
Last Updated: September 24, 2009
Health Authority: Israel: Ministry of Health processed this record on November 25, 2015