Recombinant human growth hormone (rHGH) for muscle enhancement in knee osteoarthritis: protocol for a pilot, randomised placebo-controlled trial

Shah A, Ravi B, Tomescu S, Catapano M, Burkhart TA, Whyne C, Kiss A, Marks P, Wasserstein DN · BMJ Open

A protocol with no results. The primary outcomes are feasibility (compliance and enrolment) and safety at six weeks; secondary outcomes are knee extension and flexion strength, thigh circumference, MRI quadriceps volume and patient-reported scores at 12 weeks, and radiographic arthritis progression at 24 months. The dose and duration are taken from the 2020 anterior cruciate ligament trial.

Population

Adults aged 18 to 60 with clinical and radiographic isolated degenerative knee osteoarthritis, patellofemoral or tibiofemoral, who are not surgical candidates; 17 planned per arm at one Toronto centre, 2025 to 2028

Intervention

Recombinant human growth hormone 0.5 mg per square metre of body surface once daily by subcutaneous injection for six weeks, alongside a 12-week lower-limb strengthening programme

Comparator

Saline injection once daily for six weeks with the same strengthening programme

Limitations

No data yet; a feasibility pilot of 17 a group that its own authors say is underpowered for a strength difference. Funded by the Tanenbaum Institute for Science in Sport and the Holland Sports Medicine Chair at Sunnybrook. The drug is recombinant growth hormone, not a secretagogue.