Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors

April 5, 2012 updated by: Hildegarde J. Berdine, Duquesne University

Impact of the FRAX Assessment on Physician and Patient Treatment Behavior

The study seeks to determine the impact of assessing risk for osteoporosis in women on patient and physician behaviors through a pharmacist directed osteoporosis screening program. Women will be offered a heel ultrasound to screen for their bone density and may or may not be asked questions about their risk for bone fracture. Pharmacists will counsel and educate all women on ways to prevent the onset of osteoporosis. Women will be telephoned three months after the screening and asked a series of 10 questions to follow up on decisions made by their physicians or changes made to their health behaviors related to bone health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A maximum of 90 participants will be recruited and randomized to the FRAX® assessment intervention group or the control group to a total of 45 participants in each group. The number of participants was chosen based on the simple randomized design of the study and use of basic statistics (versus regression analysis). Subjects will be recruited from the employee population of Duquesne University, clients visiting the Spirit of Health mobile health unit, and the downtown Pittsburgh community and surrounding neighborhoods of Duquesne University. Participants will be recruited through posted flyers at these various screening venues. Data collected will be the T-score at baseline screening in both groups. The percent risk for fracture as determined by the FRAX® tool will be determined for the intervention group. After 3 months have elapsed, a questionnaire will be administered via telephone to both the intervention and control groups, a series of 12 yes/no questions. Fisher's exact test will be used to analyze the data. Data collected will be nominal data with n in each group at 45 for a total of 90 participants. Descriptive statistics will also be employed.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15282
        • Duquesne University Center for Pharmacy Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria: Inclusion Criteria:

  1. Postmenopausal female participants over the age of 45 years up to and including 65 years of age. The participant will be required to have a medical doctor and covered by an insurance plan in case a DXA-scan is ordered by the physician.
  2. Ability to be screened at the Center for Pharmacy Care or at other community screenings on the Achilles® heel ultrasound bone densitometer.
  3. After heel ultrasound is conducted, include those individuals as participants in the study who present with a T-score equal to or less than -1.0.

Exclusion Criteria:

  1. Unable to participate in the follow-up survey conducted over the telephone.
  2. Age less than 45 years or over 65 years.
  3. Any individual currently taking biphosphonates for osteoporosis treatment.
  4. After heel ultrasound is conducted, if T-score is greater than -1.0.
  5. Males

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FRAX Assessment
FRAX Assessment Tool administered by a pharmacist. This group also receives a heel ultrasound and pharmacist counseling.
Other: FRAX Assessment Tool
FRAX Assessment Tool is designed to assess risk for fracture based on country of origin, race, and other factors.
Other Names:
  • WHO FRAX Risk Assessment Tool
No Intervention: Control group
Control group receives heel ultrasound and pharmacist counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavior Change
Time Frame: After 3 months or greater from screening.
Patient Health behavior changes included beginning exercise, initiating calcium and vitamin D supplements, talking with physician about osteoporosis prevention, screening by DXA scan, changing dietary intake of calcium; physician behavior changes included ordering a DXA scan, ordering vitamin D blood levels, initiating drug treatment.
After 3 months or greater from screening.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duquesne University

Collaborators

Warner Chilcott

Investigators

  • Principal Investigator: Hildegarde J Berdine, PharmD, Duquesne University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

April 4, 2012

First Submitted That Met QC Criteria

April 5, 2012

First Posted (Estimate)

April 6, 2012

Study Record Updates

Last Update Posted (Estimate)

April 6, 2012

Last Update Submitted That Met QC Criteria

April 5, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Osteo Prevention

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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