Plain English Summary
Background and study aims
Osteoporosis (weak or brittle bones) is common and often missed. Group clinics can be an option to try and diagnose this condition. Group clinics are effective and efficient in patients with arthritis (a type of swelling in the joints); however it is unsure if group clinics work for osteoporosis. The aim of this study is to see if a group clinic led by a pharmacist were as effective as usual care for people with osteoporosis.
Who can participate?
Adults over 50 with high fracture risk.
What does the study involve?
Participants are randomly allocated using a random number table to either the intervention or the control group. Those in the intervention group attend a single Pharmacist-led group clinic. Those in the control group receive the usual care, which is a single consultation delivered by Pharmacist. Participants are followed up for 12 months for medication use.
What are the possible benefits and risks of participating?
There are no benefits with participating. There are no direct risks, however participants may not like being seen in a group setting.
Where is the study run from?
This study is being run by Northumbria Healthcare (UK) and takes place practices in Northumberland CCG (UK).
When is the study starting and how long is it expected to run for?
August 2010 to August 2018
Who is funding the study?
1. National Osteoporosis Society (UK)
2. National Institute for Health Research (UK)
Who is the main contact?
1. Dr Fraser Birrell (Scientific)
Fraser.birrell@newcastle.ac.uk
2. Mrs Norma Cardill (Public)
norma.cardill@northumbria-healthcare.nhs.uk
Trial website
Contact information
Type
Public
Primary contact
Mrs Norma Cardill
ORCID ID
Contact details
Northumbria Healthcare NHS Foundation Trust
Rake Lane
North Shields
NE29 8NH
United Kingdom
+44 1670 529903
norma.cardill@northumbria-healthcare.nhs.uk
Type
Scientific
Additional contact
Dr Fraser Birrell
ORCID ID
Contact details
Northumbria Healthcare NHS Foundation Trust
Rake Lane
North Shields
NE29 8NH
United Kingdom
+44 1670 529903
Fraser.Birrell@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12765
Study information
Scientific title
Northumbria Osteoporosis Project: A randomised controlled trial of managing patients needing bone protection treatment through group clinics vs usual one to one care
Acronym
Study hypothesis
There will be no significant difference between medicines adherence as measured by Mean Possession Ratio (MPR) when compared with usual care (1:1 clinic), in patients being prescribed bisphosphonates for fracture prevention.
Ethics approval
NRES Committee North East - Newcastle & North Tyneside 1, 21/12/2010, 10/H0906/88
Study design
Randomised; Both; Design type: Not Specified, Not Specified, Qualitative
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Specialty: Musculoskeletal disorders, Primary sub-specialty: Metabolic Bone Disease
Intervention
Participants with high risk of fracture were identified by their practice. They were sent a letter to invite them to take part in the study. Those accepting were randomised to group clinic or usual care and seen once. In either setting they had education about osteoporosis and prescribed standard treatment.
Participants are randomly allocated using a random number table to either the intervention or the control group. Those in the intervention group attend a single Pharmacist-led group clinic. Those in the control group receive the usual care, which is a single consultation delivered by Pharmacist. Participants are followed up for 12 months for medication use.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Mean possession ratio (MPR) of bisphosphonates is measured using practice prescription records at 12 months
Secondary outcome measures
1. Persistence with treatment is the time (in months) before the drug is no longer requested measured using practice prescription records by month up to 12 months
2. Patient satisfaction with group clinics, enabling factors and active ingredients were explored with qualitative interviews of osteoporosis group clinic participants and comparison with an established, but co-designed and therefore evolving inflammatory arthritis group clinic model
3. Cost analysis of the intervention was restricted to staff costs of, as assumptions of other costs being equivalent were met
Overall trial start date
24/08/2010
Overall trial end date
31/08/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients identified as high risk of an osteoporotic fracture, needing treatment
2. Patients aged 50 years and over
3. Patients giving informed consent to the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 214; UK Sample Size: 214
Participant exclusion criteria
1. Patients not eligible for first line treatment as defined by North of Tyne Osteoporosis Guidance (encompassing FRAX calculation and NOGG guideline)
2. Patients not wishing to participate in the study
3. Patients unable to consent to participate in the study
4. Patient contraindications to bisphosphonates (upper gastrointestinal problems, severe impairment GFR<35ml/min, previous intolerance)
5. Terminally ill patients
6. Housebound patients
Recruitment start date
01/06/2012
Recruitment end date
31/07/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Northumbria Healthcare NHS Foundation Trust
North Shields
NE29 8NH
United Kingdom
Trial participating centre
Bedlingtonshire Medical Group
Bedlington
NE22 6JX
United Kingdom
Trial participating centre
Laburnum Surgery
Ashington
NE63 0XX
United Kingdom
Trial participating centre
Lintonville Medical Group
Lintonville Terrace
Ashington
NE63 9UT
United Kingdom
Funders
Funder type
Government
Funder name
National Osteoporosis Society
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from wasim.baqir@nhs.net
Intention to publish date
31/08/2019
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary