Studying bone health, weight, diabetes and muscle in adults with osteoporosis

Trial details

Who runs it

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Trial code

NCT07014306

Record updated

10 June 2025

Original description

Osteoporosis is a chronic condition characterised by reduced bone mass and microarchitectural deterioration of bone tissue leading to fracture. One in two adult women and one in five men will sustain a fragility fracture in their lifetime. The fractures caused by osteoporosis are a leading cause of morbidity and mortality. Optimising bone health and prevention of fracture is the best management strategy and requires detection and correction of any risk factors associated with fracture.Read full original descriptionShow less

Real-World Long-Term Musculoskeletal and Extra-Skeletal Outcomes of Obesity, Diabetes, Ageing, Frailty, and Sarcopenia: The Oswestry Metabolic BONE Cohort

Osteoporosis is a chronic condition characterised by reduced bone mass and microarchitectural deterioration of bone tissue leading to fracture. One in two adult women and one in five men will sustain a fragility fracture in their lifetime. The fractures caused by osteoporosis are a leading cause of morbidity and mortality. Optimising bone health and prevention of fracture is the best management strategy and requires detection and correction of any risk factors associated with fracture.

Multiple studies have established clinical risk factors associated with fracture, including low bone mineral density (BMD), lifestyle factors such as smoking and excessive alcohol intake, a parental history of hip fracture, and glucocorticoid use, among others. The incorporation of these clinical risk factors with BMD using the well validated Fracture Risk Assessment Tool (FRAX) over the last two decades has significantly improved fracture risk prediction. Nonetheless, BMD and FRAX have limitations, and many patients continue to experience fractures despite having normal or elevated BMD and no identifiable FRAX elements. Additionally, FRAX does not utilise any biomarkers, many of which may have a significant role in fracture risk.

Beyond the traditional well-established clinical risk factors incorporated into FRAX, new comorbidities have emerged in recent years as important determinants of bone strength and susceptibility to fracture. Obesity, type II diabetes, sarcopenia (age related progressive loss of muscle tissue), and frailty are global pandemics and have been increasingly linked with fracture risk. On the case of obesity, for example, there has been an increasing debate whether obese patients are at higher or lower risk for fracture. Whilst Body Mass Index (BMI) remains the most widely used measure of obesity, BMI is not a direct measurement of central obesity which is better assessed by waist circumference, percentage body fat measured by whole body areal bone mineral density (BMD), or visceral fat area measured by computed tomography (CT). In 2023, the National Institute for Health and Care Excellence (NICE) recommended the measurement of waist to height ratio (WHtR) as a practical estimate of central adiposity with a ratio of ≥ 0.6 as a cut-off for high central adiposity. Waist circumference was introduced in the metabolic bone unit at the Robert Jones and Agnes Hunt Orthopaedic Hospital (RJAH) as a routine clinical measurement in 2023 following NICE recommendation. In addition to obesity, clinical frailty measured by the Rockwood Clinical Frailty Scale, sarcopenia which is a state of reduced muscle power and declined muscle function, and type 2 diabetes are all variables that can be easily collected in routine clinical practice and are likely to play significant roles in numerous health outcomes including ageing, fracture, and mortality. Along with routine measurements, taken as standard of care, we also plan to utilise some of the latest scientific techniques and research into metabolomics and microbiome studies in subgroups of our patients. Further research is urgently needed in these areas to further the osteoporosis field and benefit patients at risk of fracture.

The metabolic bone service at RJAH is one of the largest metabolic services in the UK in terms of patient numbers and our service continues to experience a significant growth in demand. We have a considerable amount of data collected from patients attending the metabolic clinic and bone density unit over many years. We have a track record of successfully using patient data, anonymously, to enhance our knowledge of bone health and the risk factors of fracture to optimise treatment for our patients through well designed research studies. We have previously assessed the use of bone markers for monitoring treatment, found relationships between levels of hormone therapy and bone density, levels of hormones on bone markers and serious side effects of bisphosphonate treatment.

Inclusion: A fragility fracture sustained during two years prior to the baseline DXA including spine, hip, wrist, humerus, pelvis, elbow, rib, sternum, clavicle, scapula, distal femur, tibia, fibula, and foot; A DXA measurement at the lumbar spine and hip between 2025-2035; Non-osteoporotic BMD (T-score >-2.5) and; Anti-osteoporosis therapy not recommended following the DXA scan.

Exclusion: Traumatic fracture; Patients who lack capacity.

ClinicalTrials.gov NCT07014306