A Randomized Trial of a Community Pharmacist-Initiated Screening and Intervention Program for Osteoporosis – The OsteoPharm Study

Study Objective:
The objective of this study is to determine the effect of a community pharmacist-initiated multifaceted intervention on the diagnosis and treatment of osteoporosis in patients at high risk of fracture. The primary outcome of this study is a composite endpoint reflecting improvement in the overall quality of osteoporosis care (performance of a formal bone mineral density test or new prescription for any osteoporosis treatment within 4 months of study entry). Secondary outcomes will assess the use of calcium and vitamin D supplements, patient osteoporosis knowledge and changes in health status and osteoporosis specific quality of life.

Principal Investigator:
Nese Yuksel, B.Sc.Pharm., PharmD

Co-investigators:
Ross Tsuyuki, PharmD, MSc, Sumit Majumdar, MD, MPH, Cathy Biggs, B.Sc.Pharm.

Start date of study:
September 27, 2005

End date of study:
December 2007

Population studied:
Male or female who are (a) over the age of 50 (b) considered at high risk for osteoporosis and fracture (according to the 2002 Osteoporosis Society of Canada (OSC) guideline recommendations) and (c) live in the Capital Health Region, are eligible for study participation.

Research site:
Patient assessment and recruitment occurs at 12 community pharmacies (Save-On Foods) in the Capital Health Region (Edmonton and surrounding areas). Data collection, quality assurance and statistical analysis performed by EPICORE Centre/COMPRIS, Division of Cardiology, University of Alberta, Edmonton, Alberta.

Study design:
A randomized, controlled multi-site trial with blinded ascertainment of outcomes will be used. A sample size of 250 patients will be recruited (this sample size provides 90 % power to detect a 20 % increase in the primary composite event rate and is inflated slightly to account for dropouts and loss to follow-up). Analysis will use the intention to treat principle and primary and secondary endpoints will be evaluated with Chi square tests, t-tests, and the Wilcoxon rank-sum test.

Methods:
Participating community pharmacists will screen patients who present to their community pharmacy for entry into the study. The pharmacist will ask potential participants a series of questions developed from the 2002 OSC guideline recommendations. Those patients satisfying the inclusion criteria will be asked to give written consent to participate in the study. Qualifying patients will then be randomized through a secure Internet randomization service (using a sequence stratified by site with a block size of 4) to either the usual care or osteoporosis intervention group. Patients from both groups will be asked to complete quality of life assessment tools, and a detailed assessment of risk factors for osteoporosis will be conducted by the pharmacist. The intervention group will participate in an individual 45 minute educational and clinical session. The pharmacist will educate the patient about osteoporosis (definition, risk factors, diagnosis, calcium and vitamin D requirements, lifestyle factors to prevent further bone loss), and perform and interpret (with the patient) a heel ultrasound using the CUBA Clinical Bone Density Sonometer. The results of the heel ultrasound will be faxed to the patient’s primary care physician along with a clinical interpretation by the pharmacist. Patients in the intervention group will also be referred to their primary care physician for further potential management. Patients in the intervention group will be contacted by phone at 2 and 8 weeks, and asked to return to the pharmacy at 16 weeks. Patients randomized to usual care will be given an OSC osteoporosis education pamphlet at time of enrolment and will be asked to return for follow up at week 16. These patients will also receive a follow up phone call to remind them of the week 16 visit. The return visit at week 16 will assess primary and secondary outcomes. After this final visit, usual care patients will be offered the intervention group components (heel ultrasound and osteoporosis education). All analyses will use the intention to treat principle. Chi square tests, t-tests, and the Wilcoxon rank-sum test will be used to evaluate primary and secondary endpoints.

Patient education:
Patient Pamphlet (here)

Publications: