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

April 4, 2012
April 5, 2012
February 2010
November 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01572766 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Osteoporosis
  • Osteopenia
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
  • Active Comparator: FRAX Assessment
    FRAX Assessment Tool administered by a pharmacist. This group also receives a heel ultrasound and pharmacist counseling.
    Intervention: Other: FRAX Assessment Tool
  • No Intervention: Control group
    Control group receives heel ultrasound and pharmacist counseling

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
February 2011
November 2010   (final data collection date for primary outcome measure)

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
Female
45 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01572766
Osteo Prevention
No
Hildegarde J. Berdine, Duquesne University
Duquesne University
Warner Chilcott
Principal Investigator: Hildegarde J Berdine, PharmD Duquesne University
Duquesne University
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP