Improving Management of Patients at High Risk for Osteopo... | NCT00139438

Studies
Improving Management of Patients at High Risk for Osteoporotic Fractures (0000-038)

NCT00139438

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Apr 22, 2016Estimated

Enrollment

4,266

Phase

Not Applicable

Conditions

Osteoporosis

Interventions

Disease Management Assessment

Countries

Not provided

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

Apr 2016

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

Sep 2004

Primary Completion Date

Jun 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Aug 29, 2005

First Submission Date that Met QC Criteria

Aug 30, 2005

First Posted Date

Aug 31, 2005Estimated

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

Apr 21, 2016

Last Update Posted Date

Apr 22, 2016Estimated

Description Module

Brief Summary

The purpose of this study is to assess the impact of disease management interventions on percent receiving a bone densitometry test and percent appropriately prescribed a medication for osteoporosis.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4,266

Name	Type	Description	Arm Group Labels	Other Names
Disease Management Assessment	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
A composite measure of bone mineral density (BMD) testing and/or osteoporosis medications prescriptions.

Secondary Outcomes

Measure	Description	Time Frame
BMD testing, osteoporosis medication prescriptions, fracture

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Members of the Horizon Blue Cross Blue Shield of New Jersey who are at risk for osteoporosis based on age (women age 65 or older, men and women age 45 or older who have a history of fragility fracture or have a history of taking oral glucocorticoids over 3 months).

Exclusion Criteria:

Individuals who are not members of Horizon Blue Cross Blue Shield of New Jersey and who otherwise do not meet the inclusion criteria.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel H. Solomon, M.D., M.P.H.	Brigham and Woman's Hospital	Principal Investigator

Locations

Not provided

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

ID	Type	Description	Link
038
2005_049