Patients receiving haemodialysis are at very high risk of fragility fracture, yet there are no proven treatments for fracture prevention. We will advance a pilot study on the feasibility of a large, pragmatic, randomised controlled trial (RCT) of denosumab for fragility fracture prevention in haemodialysis.

PRevEnting FracturEs in REnal Disease-1 is a pragmatic, open-label, pilot study of an RCT of a denosumab care pathway embedded in routine care haemodialysis centres.

We will recruit at least 60 participants at high risk of fracture from at least 6 haemodialysis centres in Ontario, Canada. They must be aged 40 years or older, have access to provincial drug coverage, have appropriate baseline calcium and parathyroid hormone levels and be deemed suitable for denosumab by their kidney care provider. Participants will be randomised 1:1 to denosumab (with supports to mitigate hypocalcaemia) versus usual care using block randomisation by a central statistician (computer-generated sequence). Primary outcomes include recruitment feasibility and adherence. Secondary outcomes include safety (hypocalcaemia) and participant satisfaction with our protocol and processes. Study investigators and data analysts will be blind to treatment allocation.

We will present results descriptively. The trial was approved by Clinical Trials Ontario and local research ethics boards across study sites.

Primary and secondary outcomes will be published on trial completion.

This pilot will inform the feasibility of conducting a large-scale, efficiently run, pragmatic RCT to test whether a denosumab care pathway safely reduces the risk of fragility fracture in patients receiving haemodialysis. Results have the potential to transform fracture care in real-world patients with kidney and metabolic bone disease.

NCT05096195.

Knee osteoarthritis (OA) is a serious public health problem since it is linked to loss of muscular function and independence, especially in older adults. In this study, the researchers have proposed a randomised controlled trial with a three-arm study strategy to explore the effectiveness of an oral nutritional supplementation containing hydroxymethylbutyrate and undenatured type-II collagen combined with exercise training (ET) on the OA-related symptoms and biomarkers among adults with knee OA.

Adults with knee OA aged between 50 years and 75 years will be invited to participate in the study and thereafter will be randomly assigned to either one of three groups: oral nutrition supplementation+ET, ET or usual care. The primary outcomes include changes in OA-related symptoms and biomarkers. The secondary outcomes include changes in body composition, blood profiles, physical fitness, quality of life, dietary intake, disability, psychology status and morphological changes of the knee.

Ethics approval was granted by the Medical Research Ethics Committee of the National University of Malaysia (reference number JEP-2024–264). Findings of this study will be disseminated via peer-reviewed presentations at scientific conferences as well as open access publications.

ISRCTN14284561.