Abstract
Introduction
In osteonecrosis of the femoral head (ONFH), progression of collapse is influenced by a repair reaction, especially bone resorptive activity, around the necrotic bone. Alendronate is a potent inhibitor of bone resorption by inhibiting osteoclast activity. We performed a clinical study to test if systemic alendronate treatment would prevent the development of collapse in patients with ONFH.
Methods
Thirty-three hips in 22 ONFH patients with initial ARCO Stage 1 to 3 were included. Fourteen patients (20 hips) received daily administration of oral alendronate 5mg/day (alendronate group) and 8 patients (13 hips) did not receive alendronate administration (Control group). Baseline investigations included anteroposterior and lateral plain radiographs, T1-weighted magnetic resonance imaging (MRI), and biochemical markers (urinary NTX and serum BAP). Examination of the biochemical markers were repeated at 3, 6, and 12 months, and MRI imaging was repeated at 12 months. At 3 years, clinical symptoms and findings on plain radiographs were compared between the 2 groups. Advancement of ARCO stages or increase of collapse by more than 2 mm were considered as development of collapse.
Results
At baseline, there were no significant differences regarding patients' age, distribution of gender, etiology, ARCO radiographic stage, and extent of necrosis between the 2 groups. In the alendronate group, there was an early decrease of osteoclast activity (NTX) and osteoblastic activity (BAP) at 3 months, with significantly larger decrease in NTX (43%) than BAP (21%) at 12 months. At 3 years, development of collapse was observed in 7 hips (54%) of the Control group, and in 3 hips (15%) of the alendronate group. Hip pain was noted in 9 hips (69%) of the Control group, and in 6 hips (30%) of the alendronate group. There was a significant difference oncollapse development and occurrence of hip pain between the two groups (p<0.05). Signal change around the necrotic region on serial MRI images during the first 1 year was observed in 54 % of the Control group, and only 11% of the alendronate group.
Conclusion
Alendronate therapy decreased biochemical markers, especially osteoclast activity, after an early period from start of administration. Several clinical studies have shown promising short-term results for prevention of collapse in ONFH by administration of bisphosphonates. The present study showed a significant preventing effect of collapse development by administration of alendronate which was maintained for 3 years of treatment. Low incidence of signal change on serial MRI images may also reflect decrease of repair activity in the alendronate group. Further studies with longer follow-up, larger numbers of patients, and randomized administration of the drug among patients are required., However, alendronate administration may become one of the effective conservative treatments which might obviate the need for osteotomy or replacement surgery in some populations of ONFH patients.
