NoSH Study
Research type
Research Study
Full title
The Nottingham Spinal Health (NoSH) Study
IRAS ID
203286
Contact name
Terence Ong
Contact email
Sponsor organisation
Research and Innovation
Clinicaltrials.gov Identifier
16/EE/0249, REC reference number - East of England - Cambridge Central
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Low-trauma vertebral fractures are fragility fractures affecting the bones (vertebra) of the spinal column. It is most commonly caused by osteoporosis, a chronic condition characterised by progressive loss of bone density and strength making it at risk of breaking (fracture). 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. Hence, those that do need admission into hospital are more likely to have sustained a serious fracture and be in significant pain and disability. This specific group of patients have not been robustly studied and our 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. A better understanding of this group of patients will help the hospital team deliver better care to them; and identify knowledge gaps that will benefit from further research. We aim to recruit patients admitted to a large university hospital with a vertebral fragility fracture over a twelve month period. We will exclude those with a history of cancer; those presenting as part of a major trauma; and those with another fracture elsewhere. Data will be collected using a combination of patient interview and medical case notes at the point of hospital admission; prior to discharge; and at six months. Data collected will include information on patient demographics, characteristics (body function, limitation of activities, memory, mobility, mood), fracture details, hospital treatment, complication while in hospital, quality of life, and healthcare resource utilisation after discharge from hospital.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
16/EE/0249
Date of REC Opinion
22 Jul 2016
REC opinion
Further Information Favourable Opinion