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

This study has been terminated.

Sponsors and Collaborators:	Sanofi-Aventis Procter and Gamble
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00544180

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 IV

MedlinePlus related topics: Osteoporosis

Drug Information available for: Risedronate sodium Risedronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Record on Satisfaction of Patients With Actonel 35 mg Once a Week

Further study details as provided by Sanofi-Aventis:

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)

Eligibility

Ages Eligible for Study:	55 Years to 80 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544180

Locations

Israel
Sanofi-Aventis
Natanya, Israel

Sponsors and Collaborators

Sanofi-Aventis

Procter and Gamble

Investigators

Study Director:

Jean-Marc Chantelot, MD

Sanofi-Aventis

More Information

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	RISED_L_01686
Study First Received:	October 15, 2007
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00544180
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Calcium, Dietary
Musculoskeletal Diseases
Osteoporosis

Bone Diseases, Metabolic
Bone Diseases
Risedronic acid

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Calcium Channel Blockers
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009