Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors
Primary Purpose
Osteoporosis, Osteopenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FRAX Assessment Tool
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Osteoporosis, Pharmacist, Behavior Change, FRAX, Osteopenia
Eligibility Criteria
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.
Exclusion Criteria:
- Unable to participate in the follow-up survey conducted over the telephone.
- Age less than 45 years or over 65 years.
- Any individual currently taking biphosphonates for osteoporosis treatment.
- After heel ultrasound is conducted, if T-score is greater than -1.0.
- Males
Sites / Locations
- Duquesne University Center for Pharmacy Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
FRAX Assessment
Control group
Arm Description
FRAX Assessment Tool administered by a pharmacist. This group also receives a heel ultrasound and pharmacist counseling.
Control group receives heel ultrasound and pharmacist counseling
Outcomes
Primary Outcome Measures
Behavior Change
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01572766
First Posted
April 4, 2012
Last Updated
April 5, 2012
Sponsor
Duquesne University
Collaborators
Warner Chilcott
1. Study Identification
Unique Protocol Identification Number
NCT01572766
Brief Title
Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors
Official Title
Impact of the FRAX Assessment on Physician and Patient Treatment Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duquesne University
Collaborators
Warner Chilcott
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia
Keywords
Osteoporosis, Pharmacist, Behavior Change, FRAX, Osteopenia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FRAX Assessment
Arm Type
Active Comparator
Arm Description
FRAX Assessment Tool administered by a pharmacist. This group also receives a heel ultrasound and pharmacist counseling.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group receives heel ultrasound and pharmacist counseling
Intervention Type
Other
Intervention Name(s)
FRAX Assessment Tool
Other Intervention Name(s)
WHO FRAX Risk Assessment Tool
Intervention Description
FRAX Assessment Tool is designed to assess risk for fracture based on country of origin, race, and other factors.
Primary Outcome Measure Information:
Title
Behavior Change
Description
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.
Time Frame
After 3 months or greater from screening.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Exclusion Criteria:
Unable to participate in the follow-up survey conducted over the telephone.
Age less than 45 years or over 65 years.
Any individual currently taking biphosphonates for osteoporosis treatment.
After heel ultrasound is conducted, if T-score is greater than -1.0.
Males
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hildegarde J Berdine, PharmD
Organizational Affiliation
Duquesne University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duquesne University Center for Pharmacy Care
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15282
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21438699
Citation
Watts NB. The Fracture Risk Assessment Tool (FRAX(R)): applications in clinical practice. J Womens Health (Larchmt). 2011 Apr;20(4):525-31. doi: 10.1089/jwh.2010.2294. Epub 2011 Mar 25.
Results Reference
background
PubMed Identifier
21720894
Citation
Elias MN, Burden AM, Cadarette SM. The impact of pharmacist interventions on osteoporosis management: a systematic review. Osteoporos Int. 2011 Oct;22(10):2587-96. doi: 10.1007/s00198-011-1661-7. Epub 2011 Jul 1.
Results Reference
background
PubMed Identifier
21412137
Citation
Izuora KE, Alazraki N, Byrd-Sellers J, Tangpricha V, Nanes MS. Fracture assessment tool risk scores in bone density reports do not change physician prescribing behavior for osteoporosis. Am J Med Sci. 2011 Jul;342(1):5-8. doi: 10.1097/MAJ.0b013e31820aba02.
Results Reference
result
Links:
URL
http://www.nof.org
Description
National Osteoporosis Foundation
URL
http://www.shef.ac.uk/FRAX
Description
World Health Organization Fracture Risk Assessment Tool
Learn more about this trial
Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors
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