One Year Zoledronic Acid Therapy In Postmenopausal Osteoporosis

Abstract

Osteoporosis is a chronic and progressive disorder characterized by reduced bone strength and increased susceptibility to fracture by minor trauma. Numerous safe and effective treatments can reduce the risk and recurrent fractures with the use of oral bisphosphonate therapy. However, some patients experience side effects or have contraindications to oral bisphophonate therapy. In the case of such individuals, we designed an observational clinical test to assess the efficacy and safety of a 4 mg annual intravenous administration with zoledronic acid in osteoporotic women, and in preventing clinically evident fractures following low trauma. The zoledronic acid is a new generation, efficacious and well-tolerated intravenous bisphosphonate that is the most potent updated inhibitor of bone resorption. Methods: We included a total of 20 postmenopausal women raging from 52 to 80 years old. (mean age 64.7 +-9.2 years old) , ambulatory patients unwilling or unable to use an oral bisphosphonate. Each participant had a Bone Mineral Density (BMD) measurement (Norland XR 36) in hip and spine, previous to this study and another measurement was taken at one year later. The Group receiving zoledronic acid 4 mg stat by one hour intravenous infusions. Results: At one year the increase of the BMD, in spine, was positive in 17 patients with an average of +4.5% and was negative in 3 patients with an average of -2.46%. In trochanter area, 12 of responded positively with +4.5% and 8 patients did not respond with -4.2%. The non responding patients were older than 70 years, with a height ≤ 160 cm., weight ≤ 55 kg. and BMI ≤ 24 kg/cm2 . The adverse events were myalgias 40% (8/20), symptoms similar to influenza 10% (2/20), and all were relieved with paracetamol. There were not axial or peripheral fractures in the year following to treatment In Conclusion, the result of this observational study evidenced that the yearly intravenous administration schedule of zoledronic acid, is safe and effective, based on change in BMD and prevented hip and spine fractures in women who have osteoporosis.