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Zoledronic Acid (Reclast®, Aclasta®): A Review in Osteoporosis

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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-to-moderate 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.

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Acknowledgements

During the peer review process, the manufacturer of zoledronic acid (Reclast®, Aclasta®) was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Sohita Dhillon

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  1. Sohita Dhillon
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Correspondence to Sohita Dhillon.

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The preparation of this review was not supported by any external funding.

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Sohita Dhillon is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information

The manuscript was reviewed by: J. Iwamoto, Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, Japan; H. Kaji, Department of Physiology and Regenerative Medicine, Kinki University Faculty of Medicine, Osaka, Japan; J. M. Kaufman, Department of Internal Medicine, Ghent University, Ghent, Belgium; I. Reid, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand; J. Takada, Department of Orthopedic Surgery, Sapporo Medical University, Sapporo, Japan.

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Dhillon, S. Zoledronic Acid (Reclast®, Aclasta®): A Review in Osteoporosis. Drugs 76, 1683–1697 (2016). https://doi.org/10.1007/s40265-016-0662-4

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