A randomised trial of a community pharmacist-initiated screening and intervention program for osteoporosis: the OsteoPharm Study

ISRCTN	ISRCTN54746861
DOI	https://doi.org/10.1186/ISRCTN54746861
Protocol serial number	186
Sponsor	University of Alberta (Canada)
Funder	Institute of Health Economics (IHE) (Canada) (account number: 186)

Submission date: 04/11/2005
Registration date: 26/01/2006
Last edited: 05/11/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nese Yuksel
Scientific

Faculty of Pharmacy and Pharmaceutical Sciences
University of Alberta
3126 Dentistry/Pharmacy Center
Edmonton
T6R 2N6
Canada

Phone	+1 780 492 4442
Email	nyuksel@pharmacy.ualberta.ca

Study information

Primary study design	Interventional
Study design	Randomised, controlled multi-site trial with blinded ascertainment of outcomes
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	OsteoPharm
Study objectives	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(s)	Ethics approval received from the University of Alberta, Health Research Ethics Board-A on the 14th June 2005.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	30/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	250
Key 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)
Key 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
Date of first enrolment	16/11/2005
Date of final enrolment	30/09/2007

Locations

Countries of recruitment

Canada

Study participating centre

Faculty of Pharmacy and Pharmaceutical Sciences

Edmonton
T6R 2N6
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/03/2006		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes