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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
Osteoporosis Drug: Risedronate Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 ]

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   (Adult, Senior)
Sexes 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.

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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

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

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronate Sodium
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on August 18, 2017