Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01572766
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : April 6, 2012
Warner Chilcott
Information provided by (Responsible Party):
Hildegarde J. Berdine, Duquesne University

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 Not Applicable

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  (Clinical Trial)
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 : February 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : February 2011

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 Name: WHO FRAX Risk Assessment Tool

No Intervention: Control group
Control group receives heel ultrasound and pharmacist counseling

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01572766

United States, Pennsylvania
Duquesne University Center for Pharmacy Care
Pittsburgh, Pennsylvania, United States, 15282
Sponsors and Collaborators
Duquesne University
Warner Chilcott
Principal Investigator: Hildegarde J Berdine, PharmD Duquesne University

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Hildegarde J. Berdine, Associate Professor of Pharmacy Practice, Duquesne University Identifier: NCT01572766     History of Changes
Other Study ID Numbers: Osteo Prevention
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: April 2012

Keywords provided by Hildegarde J. Berdine, Duquesne University:
Behavior Change

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases