Does Zoledronate Prevent Femoral Head Collapse from Osteonecrosis? A Prospective, Randomized, Open-Label, Multicenter Study.

Abstract

BACKGROUND: Osteonecrosis of the femoral head frequently leads to collapse of the necrotic portion and subsequent degenerative joint disease of the hip, which is the most common diagnosis leading to total hip arthroplasty in young adults. Bisphosphonate therapy has been reported to potentially retard the collapse. We conducted a two-year prospective, randomized, open-label, multicenter study to determine whether zoledronate prevents the collapse and reduces the need for total hip arthroplasty.

METHODS: We randomly assigned patients who had Steinberg stage-I or II nontraumatic osteonecrosis of the femoral head with a necrotic area of ≥30% to either the zoledronate group or the control group. Patients in the zoledronate group received 5 mg of zoledronate intravenously per year for two years, while patients in the control group did not receive this medication. The primary efficacy outcome was the survival rate in terms of the occurrence of collapse (≥2 mm). The patients were observed for a minimum of two years after enrollment.

RESULTS: A total of 110 patients (110 hips) underwent randomization; fifty-five patients were assigned to the zoledronate group and fifty-five, to the control group. During the two-year follow-up, twenty-nine femoral heads in the zoledronate group and twenty-two in the control group collapsed (p > 0.05). Nineteen hips in the zoledronate group and twenty in the control group underwent total hip arthroplasty (p > 0.05).

CONCLUSIONS: Zoledronate for Steinberg stage-I or II osteonecrosis of the femoral head, with a medium to large necrotic area, did not prevent the collapse of the femoral head or reduce the need for total hip arthroplasty.

LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.