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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00544180
• Other study ID #: RISED_L_01686
• Status: Terminated
• Phase: Phase 4
• First received: October 15, 2007
• Last updated: September 24, 2009
• Start date: May 2005

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Risedronate

Locations

Country	Name	City	State
Israel	Sanofi-Aventis	Natanya

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Procter and Gamble

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction and compliance		During all the study	No