Back to resultsROSPA - Record on Satisfaction of Patients With Actonel 35 mg Once a Week
Primary Purpose
Osteoporosis
Status
Terminated
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Risedronate
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
Patient satisfaction and compliance
Secondary Outcome Measures
Full Information
NCT ID
NCT00544180
First Posted
October 15, 2007
Last Updated
September 24, 2009
Sponsor
Sanofi
Collaborators
Procter and Gamble
1. Study Identification
Unique Protocol Identification Number
NCT00544180
Brief Title
ROSPA - Record on Satisfaction of Patients With Actonel 35 mg Once a Week
Official Title
Record on Satisfaction of Patients With Actonel 35 mg Once a Week
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Terminated
Why Stopped
The trial was terminated due to lack of compliance with GCP regulations.
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
Collaborators
Procter and Gamble
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Risedronate
Primary Outcome Measure Information:
Title
Patient satisfaction and compliance
Time Frame
During all the study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc Chantelot, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Natanya
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
ROSPA - Record on Satisfaction of Patients With Actonel 35 mg Once a Week
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