OVERVIEW

PRODUCT INFORMATION

REPRESENTATIVE TRADE NAMES

Romosozumab – Evenity®

DRUG CLASS

Osteoporosis Agents

COMPLETE LABELING

Product labeling at DailyMed, National Library of Medicine, NIH

CHEMICAL FORMULA AND STRUCTURE

ANNOTATED BIBLIOGRAPHY

References updated: 08 June 2021

• Nolin TD, Friedman PA. Agents affecting mineral ion homeostasis and bone turnover. In, Brunton LL, Hilal-Danan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 887-906.

  (Textbook of pharmacology and therapeutics).
• FDA. https://www​.accessdata​.fda.gov/drugsatfda_docs​/nda/2019/761062Orig1s000MultidisciplineR.pdf.

  (Multidisciplinary review of romosozumab by the FDA in support of its approval for use in osteoporosis in the US with discussion of safety: pp 106-155; no mention of ALT elevations and no serious adverse hepatic events listed).
• Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, et al. Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med. 2016;375:1532–43. [PubMed: 27641143]

  (Among 7180 postmenopausal women with osteoporosis treated with romosozumab or placebo by subcutaneous injection once monthly for 12 months [followed by denosumab for 12 months], bone mineral density increased and vertebral fractures were less frequent with romosozumab [0.5% vs 1.8%], while adverse event rates were similar in the 2 groups; no mention of ALT elevations or hepatotoxicity).
• Langdahl BL, Libanati C, Crittenden DB, Bolognese MA, Brown JP, Daizadeh NS, Dokoupilova E, et al. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. Lancet. 2017;390(10102):1585–94. [PubMed: 28755782]

  (Among 436 postmenopausal women with osteoporosis refractory to bisphosphonate therapy who were treated with romosozumab [120 mg sc once monthly] or teriparatide [20 µg sc daily] for 12 months, total hip bone mineral density increased on romosozumab [+2.6%] but decreased on teriparatide [-0.6%], while adverse event rates were similar; no mention of ALT elevations or hepatotoxicity).
• McClung MR, Brown JP, Diez-Perez A, Resch H, Caminis J, Meisner P, Bolognese MA, et al. Effects of 24 months of treatment with romosozumab followed by 12 months of denosumab or placebo in postmenopausal women with low bone mineral density: a randomized, double-blind, phase 2, parallel group study. J Bone Miner Res. 2018;33:1397–1406. [PubMed: 29694685]

  (Among 364 postmenopausal women with osteoporosis treated with one of 5 regimens of romosozumab for up to 24 months, lumbar spine and total hip bone marrow density continued to increase over time, with highest gains with 210 mg once monthly and adverse event rates were similar among groups; no mention of ALT elevations or hepatotoxicity).
• Lewiecki EM, Blicharski T, Goemaere S, Lippuner K, Meisner PD, Miller PD, Miyauchi A, et al. A phase III randomized placebo-controlled trial to evaluate efficacy and safety of romosozumab in men with osteoporosis. J Clin Endocrinol Metab. 2018;103:3183–93. [PubMed: 29931216]

  (Among 245 men, ages 55 to 90 years, with osteopenia/osteoporosis treated with monthly sc injections of romosozumab [210 mg] or placebo for 12 months, lumbar spine bone mineral density improved more with romosozumab [12% vs 1.2%] and, although total and severe adverse event rates were similar in the two groups, there was an excess of serious cardiovascular events with romosozumab [5% vs 2.5%]; no mention of ALT levels or hepatotoxicity).
• Romosozumab (Evenity) for postmenopausal osteoporosis. Med Lett Drugs Ther. 2019;61(1573):83–6. [PubMed: 31170119]

  (Concise review of the mechanism of action, clinical efficacy, safety and costs of romosozumab shortly after its approval for use in osteoporosis in the US mentions adverse events of headache, arthralgia, hypersensitivity reactions, osteonecrosis and atypical fractures as well as increase in risk for cardiovascular events; no mention of ALT elevations or hepatotoxicity).
• Drugs for postmenopausal osteoporosis. Med Lett Drugs Ther. 2020;62(1602):105–12. [PubMed: 32728009]

  (Concise review of drugs approved for therapy of postmenopausal osteoporosis including vitamin D and calcium, bisphosphonates, denosumab, teriparatide, raloxifene, estrogens, calcitonin and romosozumab, mentions that romosozumab is associated with headache and arthralgia and, in some studies, an increased risk of severe cardiovascular adverse events; no mention of hepatotoxicity or ALT elevations with any of the agents for osteoporosis).
• Tanaka S, Matsumoto T. Sclerostin: from bench to bedside. J Bone Miner Metab. 2021;39:332–40. [PubMed: 33206222]

  (Review of the discovery and cellular actions of sclerostin, a cystine knot-containing secreted glycoprotein that blocks Wnt/beta-catenin signaling that is necessary for normal bone formation and osteoblast activity; romosozumab, a monoclonal antibody to sclerostin, lowers serum levels of this protein and increases Wnt-signaling and active bone formation by osteoblasts).