ROSPA - Record on Satisfaction of Patients With Actonel 3... | NCT00544180

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

NCT00544180

Sponsor

Sanofi

Status

Terminated

Last Update Posted

Sep 25, 2009Estimated

Enrollment

7Actual

Phase

Phase 4

Conditions

Osteoporosis

Interventions

Risedronate

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The trial was terminated due to lack of compliance with GCP regulations.

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Sep 2006Actual

Completion Date

Not provided

First Submitted Date

Oct 15, 2007

First Submission Date that Met QC Criteria

Oct 15, 2007

First Posted Date

Oct 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2009

Last Update Posted Date

Sep 25, 2009Estimated

Name	Class
Procter and Gamble	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Name	Type	Description	Arm Group Labels	Other Names
Risedronate	Drug

Measure	Description	Time Frame
Patient satisfaction and compliance		During all the study

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jean-Marc Chantelot, MD	Sanofi	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068296	Risedronic Acid

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided