NCT00145080

Brief Summary

The purpose of this study is to assess the impact of disease management interventions on bone mineral density screening rates and osteoporosis treatment rates in women age 50-64 years at high risk for osteoporosis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,685

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

1.5 years

First QC Date

September 1, 2005

Last Update Submit

October 30, 2015

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density screening rates

Secondary Outcomes (1)

  • Medications adoptions; Medications adherence

Interventions

Disease Management AssessmentBEHAVIORAL

Eligibility Criteria

Age50 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Members of the Harvard Pilgrim Health Plan

You may not qualify if:

  • Individuals who are not members of the Harvard Pilgrim Health Plan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Heyworth L, Kleinman K, Oddleifson S, Bernstein L, Frampton J, Lehrer M, Salvato K, Weiss TW, Simon SR, Connelly M. Comparison of interactive voice response, patient mailing, and mailed registry to encourage screening for osteoporosis: a randomized controlled trial. Osteoporos Int. 2014 May;25(5):1519-26. doi: 10.1007/s00198-014-2629-1. Epub 2014 Feb 25.

    PMID: 24566584DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

July 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

November 2, 2015

Record last verified: 2015-10