Text Size

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:
Collaborator:
Procter and Gamble
Information provided by:
Sanofi-Aventis
ClinicalTrials.gov Identifier:
NCT00544180
First received: October 15, 2007
Last updated: September 24, 2009
Last verified: September 2009
History of Changes
  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
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:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov 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

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 17, 2012