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Published online: 18 November 2016 © Springer International Publishing Switzerland 2016
Abstract Zoledronic acid (Reclast®, Aclasta®) is an intravenous, highly potent aminobisphosphonate approved worldwide, including in the USA, EU and Japan for use in patients with primary or secondary osteoporosis or low bone mass (approved indications vary between countries). Its high affinity to and long half-life in bone, and long duration of action, allow for once-yearly administration, which has the potential to improve adherence to therapy. Zoledronic acid once yearly for up to 3 years improved bone mineral density (BMD) at several skeletal sites, reduced fracture risk and bone turnover, and/or preserved bone structure and mass relative to placebo in clinical studies in patients with primary or secondary osteoporosis. While additional benefits were seen when treatment was continued for up to 6 years, as evidenced by a reduced risk of vertebral fractures and higher BMD relative to 3 years' therapy, there was minimal advantage of treatment beyond 6 years. Therefore, in patients with low fracture risk, treatment discontinuation should be considered after approximately 5 years' therapy. Zoledronic acid administered annually or once in 2 years was also effective in preventing bone loss in patients with low bone mass. Zoledronic acid was generally well tolerated, with the most common adverse events (AEs) being transient, mild-tomoderate post-infusion symptoms, which decreased with subsequent infusions. To conclude, zoledronic acid once yearly is an effective and generally well tolerated treatment option for patients with osteoporosis.
Drugs (2016) 76:1683-1697 DOI 10.1007/s40265-016-0662-4
1 Introduction
Osteoporosis is sometimes referred to as a silent disease, as it develops painlessly, often with no symptoms until a fracture occurs [1]. Both men and women are at risk of osteoporotic fractures, most commonly spinal, hip and wrist fractures [1]. Several pharmacological options are available for the prevention and treatment of primary and secondary osteoporosis, which can be broadly categorized into antiresorptive agents (e.g. bisphosphonates, estrogen) that preserve bone mineral density (BMD) by reducing bone resorption, and anabolic agents (e.g. teriparatide) that increase BMD by stimulating bone formation. Antiresorptive agents are a cornerstone for the treatment of osteoporosis [2], with several drug classes currently available, of which bisphosphonates are often recommended as first-line options for men and women at risk of osteoporotic fractures [3-7]. Zoledronic acid (Reclast®,...