RecruitingPhase 2ACTRN12609000104257

A randomised controlled trial of bisphosphonate therapy in osteonecrosis of the hip.

A randomised controlled trial to study the effectiveness of potent bisphosphonate (Zoledronic Acid) therapy in patients with early osteonecrosis of the hip.


Sponsor

University of Sydney/ Northern Clinical School

Enrollment

120 participants

Start Date

Apr 1, 2009

Study Type

Interventional

Conditions

Summary

Osteonecrosis of the hip is an important cause of musculoskeletal disability and finding therapeutic solutions has proven to be challenging. Osteonecrosis means death of bone which can occur from the loss of the blood supply or some other means. Although any age group may develop osteonecrosis, most patients are between 20 and 50 years old. The most common risk factor is a history of high steroid treatment for some medical condition. The next most common associated condition is a history of high alcohol use. There are some cases of osteonecrosis that occur in patients that are otherwise completely healthy with no detectable risk factors. In the earliest stage of the disease, x-rays appear normal and the diagnosis is made using MRI. The advanced stages of osteonecrosis begin when the dead bone starts to fail mechanically through a process of microfractures of the bone. As the disease progresses, the surace begins to collapse until, finally the integrity of the joint is destroyed. A wide range of surgical treatments with variable success rates have been proposed for the treatment of the osteonecrosis to preserve joint integrity, including core decompression, whereby the venous hypertension that ensues is lessened and revascularisation may be induced leading to bone repair. Nonsurgical treatment options are limited and usually result in a poor prognosis. Early stage disease can be treated with protected weight bearing and physiotherapy, however some studies have shown protected weight bearing to be associated with a greater than 85% rate of femoral head collapse. Unfortunately most studies indicate that the risk for disease progression is greater with nonsurgical treatment than with surgical intervention. There are no esthablished pharmaceuticals for the prevention of treatment of osteonecrosis. Evidence is increasing that the nitrogen containing bisphosphonates may be beneficial in the treatment of osteonecrosis. One bisphosphonates (alendronate) has been evaluated in 60 patients diagnosed with osteonecrosis of the hip. Recent clinical studies have shown very promising results. All patients had symptomatic improvement after one year. Although the follow up time ranged from 3 months to 5 years, only 6 patients progressed to the point of needing surgery.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a type of bone-strengthening medicine called a bisphosphonate can help people with osteonecrosis of the hip — a condition where part of the hip bone dies due to loss of blood supply. This can cause serious pain and eventually lead to joint collapse. The study will compare people taking the medicine against those taking a placebo to see whether it prevents the bone from getting worse and reduces the need for surgery. You may be eligible if: - You are between 18 and 80 years old - You have pain and disability in at least one hip joint - An MRI has shown early to moderate osteonecrosis (Stage I or II on the ARCO classification) You may NOT be eligible if: - You have had previous hip surgery on the affected hip - You have severe pain at rest and your doctor has already recommended surgery - Your imaging shows more advanced disease (Stage III or IV on the ARCO classification) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Participants will be randomised to one of two groups, the intervention (zoledronic acid infusion) and control group (placebo infusion). Participants will have a 66% chance of being in the intervention

Participants will be randomised to one of two groups, the intervention (zoledronic acid infusion) and control group (placebo infusion). Participants will have a 66% chance of being in the intervention group and a 33% chance of being in the control group. Subjects in the intervention group will be given 5mg Zoledronic acid (via infusion) annually for 3 doses, this means one dose a year for 3 years. Patients with low serum 25OH vitamin D will be supplemented before zoledronate administration.


Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12609000104257