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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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00544180
First Posted: October 16, 2007
Last Update Posted: September 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Procter and Gamble
Information provided by:
Sanofi
  Purpose
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)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544180


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00544180     History of Changes
Other Study ID Numbers: RISED_L_01686
First Submitted: October 15, 2007
First Posted: October 16, 2007
Last Update Posted: September 25, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Osteoporosis
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