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Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors

This study has been completed.
Sponsor:
Collaborator:
Warner Chilcott
Information provided by (Responsible Party):
Hildegarde J. Berdine, Duquesne University
ClinicalTrials.gov Identifier:
NCT01572766
First received: April 4, 2012
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Osteoporosis
Osteopenia
 Other: FRAX Assessment Tool

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Impact of the FRAX Assessment on Physician and Patient Treatment Behavior

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duquesne University:

Primary Outcome Measures:
  • Behavior Change [ Time Frame: After 3 months or greater from screening. ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
Study Start Date: February 2010
Study Completion Date: February 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572766

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

Additional Information:
National Osteoporosis Foundation  This link exits the ClinicalTrials.gov site
World Health Organization Fracture Risk Assessment Tool  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Hildegarde J. Berdine, Associate Professor of Pharmacy Practice, Duquesne University
ClinicalTrials.gov Identifier: NCT01572766     History of Changes
Other Study ID Numbers: Osteo Prevention
Study First Received: April 4, 2012
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Duquesne University:
Osteoporosis
Pharmacist
Behavior Change
FRAX
Osteopenia

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

ClinicalTrials.gov processed this record on May 23, 2013