Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors

Sponsor

Duquesne University (Other)

Overall Status

Completed

CT.gov ID

NCT01572766

Collaborator

Warner Chilcott (Industry)

Enrollment

Location

Arms

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Osteopenia	Other: FRAX Assessment Tool	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Impact of the FRAX Assessment on Physician and Patient Treatment Behavior

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Behavior Change [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria: Inclusion Criteria:

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.
Ability to be screened at the Center for Pharmacy Care or at other community screenings on the Achilles® heel ultrasound bone densitometer.
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.