OsteoporosisNCT01572766
Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors
A study testing FRAX Assessment Tool in people with Osteoporosis and Osteopenia, run by Duquesne University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- FRAX Assessment Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duquesne University Center for Pharmacy Care
Pittsburgh, Pennsylvania, 15282
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- FRAX Assessment Tool
- Keywords
- Osteoporosis, Pharmacist, Behavior Change, FRAX, Osteopenia
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRAX Assessment ToolOther
Also called WHO FRAX Risk Assessment Tool
FRAX Assessment Tool is designed to assess risk for fracture based on country of origin, race, and other factors.
| Study group | Role | What they receive |
|---|---|---|
| FRAX Assessment | Active comparator | FRAX Assessment Tool administered by a pharmacist. This group also receives a heel ultrasound and pharmacist counseling. Receives: Other: FRAX Assessment Tool |
| Control group | No intervention | Control group receives heel ultrasound and pharmacist counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 3 months or greater from screening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startFeb 2010
- Primary completionNov 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Collaborators
- Warner Chilcott
- Responsible party
- Principal investigator, Hildegarde J. Berdine, Duquesne University
- Investigators
- Hildegarde J Berdine, PharmD, Principal investigator, Duquesne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572766
- Sponsor's protocol ID
- Osteo Prevention
- Status last verified
- Apr 2012
- First submitted
- 4 Apr 2012
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21438699Elias 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.
PubMed 21720894Izuora 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.
PubMed 21412137
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the FRAX Assessment on Physician and Patient Treatment Behavior
- ClinicalTrials.gov ID
- NCT01572766
- Acronym / sponsor ID
- Osteo Prevention
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- Osteoporosis, Pharmacist, Behavior Change, FRAX, Osteopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Collaborators
- Warner Chilcott
- Study start
- Feb 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FRAX Assessment | Active comparator | Other: FRAX Assessment ToolFRAX Assessment Tool administered by a pharmacist. This group also receives a heel ultrasound and pharmacist counseling. |
| Control group | No intervention | –Control group receives heel ultrasound and pharmacist counseling |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRAX Assessment ToolAlso: WHO FRAX Risk Assessment ToolFRAX Assessment Tool is designed to assess risk for fracture based on country of origin, race, and other factors. | Other | FRAX Assessment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
- Background: PubMed 21438699Watts 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.
- Background: PubMed 21720894Elias 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 publication: PubMed 21412137Izuora 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.
- National Osteoporosis FoundationLink provided by the sponsor.
- World Health Organization Fracture Risk Assessment ToolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hildegarde J Berdine, PharmD principal investigator
Duquesne University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRAX Assessment Tool in people with Osteoporosis and Osteopenia, run by Duquesne University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior Change (time frame: After 3 months or greater from screening.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01572766, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2012.