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 |
| Secondary identifying numbers | 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
Scientific
Faculty of Pharmacy and Pharmaceutical Sciences
University of Alberta
3126 Dentistry/Pharmacy Center
Edmonton
T6R 2N6
Canada
| Phone | +1 780 492 4442 |
|---|---|
| nyuksel@pharmacy.ualberta.ca |
Study information
| Study design | Randomised, controlled multi-site trial with blinded ascertainment of outcomes |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| 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 | 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 study start date | 16/11/2005 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
T6R 2N6
Canada
Sponsor information
University of Alberta (Canada)
University/education
University/education
Faculty of Pharmacy and Pharmaceutical Sciences
3126 Dentistry/Pharmacy Center
Edmonton
T6R 2N6
Canada
| Phone | +1 780 492 3362 |
|---|---|
| info@pharmacy.ualberta.ca | |
| Website | http://www.pharmacy.ualberta.ca/ |
"ROR" |
https://ror.org/0160cpw27 |
Funders
Funder type
Charity
Institute of Health Economics (IHE) (Canada) (account number: 186)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
