Condition category
Musculoskeletal Diseases
Date applied
04/11/2005
Date assigned
26/01/2006
Last edited
05/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.epicore.ualberta.ca/

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. Patient’s 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

http://www.pharmacy.ualberta.ca/

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

Publication citations

Additional files

Editorial Notes