Last reviewed 2026-04-20 · How we verify

Evenity (romosozumab)

At a glance

Approved indications

• Postmenopausal osteoporosis

Boxed warnings

• WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death [see Warnings and Precautions (5.1) ] . EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH See full prescribing information for complete boxed warning. EVENITY may increase the risk of myocardial infarction, stroke and cardiovascular death. ( 5.1 ) EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. ( 5.1 ) If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. ( 5.1 )

Common side effects

• Arthralgia
• Headache

Serious adverse events

• All-cause mortality
• Nonfatal serious adverse events
• Myocardial infarction
• Stroke

Key clinical trials

• Romosozumab Versus Denosumab in Patients With Glucocorticoid-induced Osteoporosis: a 2-year Extension Study of a Randomized Controlled Trial (Phase 4)
• A Randomized, Double-blind, Placebo-controlled, Ascending Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785 in Healthy Men and Postmenopausal Wom (Phase 1)
• A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate the Effect of AMG 785 on Parameters of Bone Quality of the Forearm Using pQCT in Postmenopausal Women With Low Bone Mine (Phase 1)
• Mechanisms of Anabolic Osteoporosis Therapy (NA)
• A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis (Phase 3)
• Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI (Phase 4)
• A Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Postmenopausal South Korean Women With Osteoporosis (Phase 3)
• Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI (Phase 2)

Primary sources

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