Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors
| Tracking Information | |||||
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| First Received Date ICMJE | April 4, 2012 | ||||
| Last Updated Date | April 5, 2012 | ||||
| Start Date ICMJE | February 2010 | ||||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01572766 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors | ||||
| Official Title ICMJE | Impact of the FRAX Assessment on Physician and Patient Treatment Behavior | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 90 | ||||
| Completion Date | February 2011 | ||||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 45 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01572766 | ||||
| Other Study ID Numbers ICMJE | Osteo Prevention | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Hildegarde J. Berdine, Duquesne University | ||||
| Study Sponsor ICMJE | Duquesne University | ||||
| Collaborators ICMJE | Warner Chilcott | ||||
| Investigators ICMJE |
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| Information Provided By | Duquesne University | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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