drugset / Trial / NCT04303026

The Effect of Zoledronic Acid on Patients With Osteoarthritis of the Hip

NCT04303026

RandomizedParallel-groupTriple-blindTreatment

Summary

Hip Osteoarthritis (OA) is one of the most common diseases affecting the ageing population. No specific and safe treatment slowing the development of hip OA as reflected in reduced joint space narrowing has been developed so far. Implantation of hip prosthesis has been a great success, but is expensive and puts a great financial pressure on hospitals and national healthcare programs. It also poses risks of serious complications. Current non-surgical treatment options focus on pain management and physiotherapy. Bisphosphonates have been shown to exert multiple beneficial effects in OA. Animal studies have demonstrated that bisphosphonates protect against subchondral bone degradation and preserve articular cartilage in mice and rats with OA. In this study 70 participants will be treated with either Zoledronic Acid (a potent Bisphosphonate) or Placebo (Saltwater). Allocation will be random and both parties are blinded. The investigators hypothesis is that participants treated with Zoledronic acid will have less pain, and better function after 12 months. The results will be tested with functional and pain scores, and functional tests. The study team will also measure the effects on disease related quality of life, bone quality measurements and the effect on bone marrow lesions on MRI (magnetic resonance imaging) and histological examination

Timeline

Start
2020-03-02
Primary completion
2023-06-30
Completion
2024-06-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Zoledronic acid Other / unclassified 5 mg Intravenous

Indications