Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoporosis Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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FRAX Assessment

FRAX Assessment Tool administered by a pharmacist. This group also receives a heel ultrasound and pharmacist counseling.

Group Type ACTIVE_COMPARATOR

FRAX Assessment Tool

Intervention Type OTHER

FRAX Assessment Tool is designed to assess risk for fracture based on country of origin, race, and other factors.

Control group

Control group receives heel ultrasound and pharmacist counseling

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FRAX Assessment Tool

FRAX Assessment Tool is designed to assess risk for fracture based on country of origin, race, and other factors.

Intervention Type OTHER

Other Intervention Names

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WHO FRAX Risk Assessment Tool

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes