ISRCTN - ISRCTN14436287: The Nottingham spinal health study

Plain English Summary

Background and study aims
Fragility fractures are a type of fracture which occurs as a result of normal activity, such as a fall from standing height or less. Low-trauma vertebral fractures are fragility fractures affecting the small bones that make up the spine (vertebra). It is most commonly caused by osteoporosis, a long-term condition where bones become brittle and break easily. Vertebral fragility fractures can lead to pain, limitation in daily activities, and is associated with further fragility fractures and worse healthcare outcomes. The majority of vertebral fragility fractures are treated in the community, and so those that do need admission to hospital are more likely to have sustained a serious fracture and be in significant pain and disability. This specific group of patients has not been robustly studied and this study aims to describe the characteristics of patients admitted to hospital with a vertebral fragility fracture, their care in hospital and health outcomes associated with it at six months.

Who can participate?
Adults aged 50 years and over who have been admitted to hospital because of a vertebral fragility fracture or suspected vertebral fragility fracture.

What does the study involve?
Participants who have been admitted to hospital because of a vertebral fragility fracture or suspected vertebral fragility fracture are approached by the study team to complete a number of questionnaires. In addition, their medical records are reviewed for background information about their health. Six months later, participants are contacted and repeat the initial questionnaires to look at the long-term outcomes of their fracture.

What are the possible benefits and risks of participating?
There are no direct benefits or risks to those taking part.

Where is the study run from?
Queens Medical Centre, Nottingham (UK)

When is the study starting and how long is it expected to run for?
August 2016 to March 2018

Who is funding the study?
Dunhill Medical Trust (UK)

Who is the main contact?
Dr Terence Ong
terenceong@doctors.org.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Terence Ong

ORCID ID

http://orcid.org/0000-0001-7473-446X

Contact details

Department for Healthcare of Older People
Queens Medical Centre
Nottingham University Hospitals NHS Trust
Derby Road
Nottingham
NG7 2UH
United Kingdom
+44 1159 249924 ext 62793/62511
terenceong@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16HC004

Study information

Scientific title

Nottingham Spinal Health (NoSH) Study: A cohort study of vertebral fragility fractures admitted to hospital

Acronym

NoSH

Study hypothesis

The aim of this study is to describe characteristics of adult patients admitted to hospital with vertebral fragility fractures and their associated outcomes. Findings from this study will inform the potential development of a specialist service for vertebral fracture management in hospital.

Ethics approval

Ethics approval provided by the East of England - Cambridge Central Research Ethics Committee, 22/07/2016, ref: 16/EE/0249

Study design

Single centre prospective observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

See additional files

Condition

1. Osteoporosis
2. Vertebral fractures

Intervention

Patients with a diagnosed or suspected diagnosis of an acute vertebral fragility fracture will be invited to participate in the study. Data collection will be conducted on admission, at discharge from hospital and at 6 months follow up post-discharge. Range of data collected are detailed in the accompanying section of this application. Data will be gathered from patient questionnaire and their medical case notes. This observational study will not interfere with the care delivered as part of their hospital admission.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Pain is measured using an 11 point numeric rating scale at baseline (on admission to hospital), on discharge from hospital and at 6 months
2. Mood is measured using the Geriatric Depression Scale at baseline (on admission to hospital) and at 6 months
3. Cognition is measured using the Montreal Cognitive Assessment at baseline (on admission to hospital) and at 6 months
4. Disability is measured using the Elderly Mobility Scale, Barthel Index, Nottingham Extended Activities of Daily Living and Roland Morris Disability Questionnaire at baseline (on admission to hospital) and at 6 months

Secondary outcome measures

1. Hospital inpatient mortality and overall mortality are measured by analysing healthcare records at 6 months
2. Hospital related outcomes measured by analysing hospital paper and electronic healthcare records on patients discharge - length of stay, discharge destination/changes in residency, hospital related complication (hospital acquired infection, pressure sore, venous thromboembolic event, delirium and neurological impairment)
3. Quality of life post-hospitalisation for vertebral fractures is measured using the EQ-5D measured at 6 months
4. Healthcare resource utilisation after hospital discharge is measured through self or proxy reporting at 6 months

Overall trial start date

10/08/2016

Overall trial end date

15/03/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adults aged 50 years and over
2. Admitted to hospital with either a low trauma or atraumatic vertebral fragility fracture or suspected vertebral fragility fracture pending radiology investigation. A low trauma fracture is a fracture sustained after a fall from a standing height or less. A diagnosis of vertebral fracture is made radiologically (i.e. x-ray imaging, computerised tomography (CT), magnetic resonance imaging (MRI) of the spine) or bone (scintigraphy) scan.
3. While in hospital was diagnosed with a vertebral fragility fracture unrelated to their index admission

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Patients without a vertebral fracture
2. Patients admitted electively to hospital for management of their vertebral fracture
3. Patients transferred from another hospital
4. Vertebral fracture sustained as a result of a high impact injury, e.g. road traffic accident, fall down a flight of stairs, etc.
5. Patients presenting with a concomitant fracture elsewhere
6. Patients admitted to hospital under a major trauma pathway
7. Patients with known or suspected malignancy
8. Patients with known primary bone disorder (e.g Paget’s disease) other than osteoporosis
9. Patients terminally ill or moribund

Recruitment start date

28/09/2016

Recruitment end date

18/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queens Medical Centre
Nottingham University Hospitals NHS Trust Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust

Sponsor type

Hospital/treatment centre

Website

http://nuhrise.org/

Funders

Funder type