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

• Status: Recruiting
• Trial end date: 2022-03-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Martina Hansen's Hospital
• Collaborators: Hormone Laboratory, Aker University Hospital, Oslo, Norway; University of Oslo
• Treatments: Zoledronic Acid

Criteria

Inclusion Criteria:

• Age 50-80

• Continuous worsening of hip pain with an onset of minimum 3 months

• Hip Pain intensity >40mm on a visual analogue scale (VAS) ranging from 0 (no pain) to 100mm (maximal pain) during weight bearing for the last 7 days

• HHS < 65 (Harris Hip Score)

• Hip OA fulfilling the ACR (American College of Rheumatology) criteria [33]

• Hip MRI scan showing large (>1 cm diameter) Bone Marrow lesions (BMLs)

• Willing and able to consent and comply with the study protocol

Exclusion Criteria:

• eGFR (estimated glomerular filtration rate) < 35 ml/min or hypocalcemia

• Exposure to any treatment affecting bone other than Ca+D ( bisphosphonates, Denosumab teriparatide or continuous treatment of prednisolone)

• Diseases affecting bone and joints (i.e inflammatory joint diseases, osteonecrosis with segmental collapse and deformation, primary bone cancer or known skeletal metastases)

• Severe vitamin D deficiency (S-25(OH)D < 25 nmol/l) has to be supplemented with Ca+D before zoledronic acid infusion

• Ipsilateral knee prosthesis

• Contralateral hip prosthesis

• Women of child bearing potential (WOCBP). Female participants must be in a postmenopausal state or permanent sterile.

• Hypersensitivity or previous allergic reaction to ZA or other bisphosphonates.

• Hypersensitivity or previous allergic reaction to Calcigran Forte (a calcium and vitamine D supplement) or Prednisolone