NCT01572766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

9 months

First QC Date

April 4, 2012

Last Update Submit

April 5, 2012

Conditions

OsteoporosisOsteopenia

Keywords

OsteoporosisPharmacistBehavior ChangeFRAXOsteopenia

Outcome Measures

Primary Outcomes (1)

  • 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.

    After 3 months or greater from screening.

Study Arms (2)

FRAX Assessment

ACTIVE COMPARATOR

FRAX Assessment Tool administered by a pharmacist. This group also receives a heel ultrasound and pharmacist counseling.

Other: FRAX Assessment Tool

Control group

NO INTERVENTION

Control group receives heel ultrasound and pharmacist counseling

Interventions

FRAX Assessment ToolOTHER

FRAX Assessment Tool is designed to assess risk for fracture based on country of origin, race, and other factors.

Also known as: WHO FRAX Risk Assessment Tool
FRAX Assessment

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duquesne University Center for Pharmacy Care

Pittsburgh, Pennsylvania, 15282, United States

Location

Related Publications (3)

  • 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.

    PMID: 21438699BACKGROUND

  • 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.

    PMID: 21720894BACKGROUND

  • 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.

    PMID: 21412137RESULT

Related Links

MeSH Terms

Conditions

OsteoporosisBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Hildegarde J Berdine, PharmD

    Duquesne University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pharmacy Practice

Study Record Dates

First Submitted

April 4, 2012

First Posted

April 6, 2012

Study Start

February 1, 2010

Primary Completion

November 1, 2010

Study Completion

February 1, 2011

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations

US(1)