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

NCT04303026 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-10-24

No results posted yet for this study

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

Conditions

  • Osteoarthritis, Hip

Interventions

DRUG

Zoledronic Acid

5mg IV infusion

DRUG

Saline 0.9%

Placebo Group. Saline 0.9% 100 ml infusion

Sponsors & Collaborators

  • Hormone Laboratory, Aker University Hospital, Oslo, Norway

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • Martina Hansen's Hospital

    lead OTHER

Principal Investigators

  • Erik F Eriksen, MD, PhD · Helse Sor-Ost

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04303026 on ClinicalTrials.gov