Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Nese Yuksel
ORCID ID
Contact details
Faculty of Pharmacy and Pharmaceutical Sciences
University of Alberta
3126 Dentistry/Pharmacy Center
Edmonton
T6R 2N6
Canada
+1 780 492 4442
nyuksel@pharmacy.ualberta.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
186
Study information
Scientific title
Acronym
OsteoPharm
Study hypothesis
A community pharmacist-initiated multifaceted intervention will help increase the diagnosis and treatment of osteoporosis in patients at a high risk for fracture.
Ethics approval
Ethics approval received from the University of Alberta, Health Research Ethics Board-A on the 14th June 2005.
Study design
Randomised, controlled multi-site trial with blinded ascertainment of outcomes
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Osteoporosis
Intervention
Intervention group:
Multifaceted interventions that consist of the following:
1. Screening by community pharmacists
2. Educational session on osteoporosis
3. Quantitative ultrasound (QUS) measurements
4. Referral to the primary care physician
Control group:
Usual care, defined as provision of generic pamphlet on osteoporosis.
Please note that as of 15/01/2008 the anticipated end date of this trial was extended to 30/09/2007. The previous end date of this trial was 01/10/2006.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Composite endpoint of the performance of a bone mineral density test or a new prescription for an osteoporosis medication within four months of study entry.
Secondary outcome measures
1. Each component of the primary outcome
2. Use of calcium and vitamin D supplements
3. Patients osteoporosis related knowledge using the Facts on Osteoporosis Quiz, (FoOQ)
4. Changes in generic health status (RAND-12)
5. Osteoporosis specific quality of life
Overall trial start date
16/11/2005
Overall trial end date
30/09/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Males or females who are:
1. Over the age of 50
2. Considered to be at a high risk for osteoporosis and fractures as defined by the Osteoporosis Society of Canada Clinical Practice guidelines and as defined specifically for the purposes of this study, i.e., are over the age of 65 years or between 50 - 64 years of age with any one of the following:
2.1. Family history of osteoporosis
2.2. Previous fragility fracture
2.3. Systemic steroids
2.4. Early menopause (for women)
3. Live in the Capital Health Region (Edmonton Region)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant exclusion criteria
1. Are unable or unwilling to provide informed consent
2. Are on current prescription treatment for osteoporosis
3. Have had a dual energy x-ray absortiometry (DEXA) scan performed in the past two years
4. Are non-English speaking
Recruitment start date
16/11/2005
Recruitment end date
30/09/2007
Locations
Countries of recruitment
Canada
Trial participating centre
Faculty of Pharmacy and Pharmaceutical Sciences
Edmonton
T6R 2N6
Canada
Sponsor information
Organisation
University of Alberta (Canada)
Sponsor details
Faculty of Pharmacy and Pharmaceutical Sciences
3126 Dentistry/Pharmacy Center
Edmonton
T6R 2N6
Canada
+1 780 492 3362
info@pharmacy.ualberta.ca
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Institute of Health Economics (IHE) (Canada) (account number: 186)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2006 protocol in http://www.epicore.ualberta.ca/Documents/ResearchinProgress[1].pdf