SOLID-Effect of Risedronate Sodium at Distal Radius in Co... | NCT00460733

Studies
SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.

NCT00460733

Sponsor

Sanofi

Status

Completed

Last Update Posted

Oct 4, 2011Estimated

Enrollment

141Actual

Phase

Phase 4

Conditions

Colles' Fracture

Interventions

Risedronate sodium
Calcium & Vitamine D3

Countries

Brazil

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

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Apr 13, 2007

First Submission Date that Met QC Criteria

Apr 13, 2007

First Posted Date

Apr 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

Oct 3, 2011

Last Update Posted Date

Oct 4, 2011Estimated

Name	Class
Procter and Gamble	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of risedronate sodium (Actonel®) after a wrist fracture in postmenopausal women.

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

141Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Risedronate sodium
2	Active Comparator		Drug: Calcium & Vitamine D3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Risedronate sodium	Drug	Actonel® 35 mg (risedronate sodium) and 1000 mg of calcium and 400 UI of Vitamine D3	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body mineral density of the 33% radius region and of the UD radius region		after 90 days of treatment

Secondary Outcomes

Measure	Description	Time Frame
Body mineral density of the 33% radius region and of the UD radius region		after 180 days of treatment
Size of callus obtained through Rx of the fracture site.		from the beginning up to the end of the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with description of 2 or more years of Menopause;
T-score <= -2.0 sd;
Confirmed colles'fracture;
Independent for the march (preserved ambulatorial ability);

Exclusion Criteria:

Co-morbidities;
Regular use of corticosteroids or other anti-resorptive drug in the last year;
Use of drugs that can affect the calcium metabolism;
Hypersensitivity to risedronate;
Previous wrist or forearm fracture;
Hypocalcemia;
Renal insufficiency;
Rheumatic disease;

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

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaderson Lima	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		São Paulo			Brazil

Condition Browse Module

MeSH Terms

ID	Term
D003100	Colles' Fracture

Ancestor Terms

ID	Term
D000072039	Fracture Dislocation
D004204	Joint Dislocations
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068296	Risedronic Acid
D002118	Calcium

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided