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

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. Identifier: NCT00544180
Recruitment Status : Terminated (The trial was terminated due to lack of compliance with GCP regulations.)
First Posted : October 16, 2007
Last Update Posted : September 25, 2009
Procter and Gamble
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoporosis Drug: Risedronate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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
Study Start Date : May 2005
Actual Primary Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Primary Outcome Measures :
  1. Patient satisfaction and compliance [ Time Frame: During all the study ]

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.

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
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.

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 identifier (NCT number): NCT00544180

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

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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00544180     History of Changes
Other Study ID Numbers: RISED_L_01686
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: September 25, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Risedronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents