Osteoporosis Disease Management Demonstration Project (00... | NCT00145067

Studies
Osteoporosis Disease Management Demonstration Project (0000-040)

NCT00145067

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Nov 3, 2015Estimated

Enrollment

230Actual

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

Nov 2015

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

Nov 2003

Primary Completion Date

Jun 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Sep 1, 2005

First Submission Date that Met QC Criteria

Sep 2, 2005

First Posted Date

Sep 5, 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

Nov 2, 2015

Last Update Posted Date

Nov 3, 2015Estimated

Description Module

Brief Summary

The purpose of the study is to evaluate the impact disease management interventions in treatment compliance among post-fracture and osteoporosis patients.

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

230Actual

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

Measure	Description	Time Frame
Treatment persistence

Measure	Description	Time Frame
Patient satisfaction and knowledge

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Members of of the Kaiser Permanente Health Plan who have fractured a bone.

Exclusion Criteria:

Individuals who are not members of the Kaiser Permanente Health Plan.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19659407	Derived	Waalen J, Bruning AL, Peters MJ, Blau EM. A telephone-based intervention for increasing the use of osteoporosis medication: a randomized controlled trial. Am J Manag Care. 2009 Aug 1;15(8):e60-70.

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

ID	Type	Description	Link
040
2005_051