INDICATION

EVENITY™ is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Read More

available osteoporosis therapy. The anabolic effect of EVENITY™ wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY™ use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an antiresorptive agent should be considered. Close

EVENITY™ VS ALENDRONATE (ARCH)

EVENITY™ for 12 months followed by alendronate provided superior vertebral and nonvertebral fracture risk reduction vs alendronate alone1

Start with EVENITY™ first after fracture when your patients' risk of another is at its highest1,2

EVENITY™ First Followed by Alendronate vs Alendronate Alone1,3
Fracture Risk Reduction
Incidence of fractures (%)

This was an event-driven trial and the duration of follow-up varied across subjects. The median duration of subject follow-up for the primary analysis period was 33 months1

EVENITY™ for 12 months followed by alendronate reduced the incidence of clinical fracture (nonvertebral and symptomatic vertebral fracture) at primary analysis (median 33 months) (P < 0.001)1

*Absolute and relative risk reductions are based on the Mantel‑Haenszel method adjusting for age strata, baseline total hip BMD T‑score (≤ -2.5,>-2.5), and presence of severe vertebral fracture at baseline.

P value based on logistic regression model (new vertebral fracture) or Cox proportional hazards model (other fracture types) adjusting for age strata, baseline total hip BMD T‑score, and presence of severe vertebral fracture at baseline.

Nonvertebral fractures excluded fractures of the skull, facial bones, metacarpals, fingers, and toes. Pathologic or high trauma fractures were also excluded.

ARR = absolute risk reduction.

EVENITY™ rapidly increased BMD
in just 12 months1

BMD superiority vs alendronate across key sites1

  • Within 12 months vs alendronate, EVENITY™ demonstrated significant improvements in BMD at the lumbar spine, total hip, and femoral neck
  • Gains were sustained after follow-on treatment with alendronate
EVENITY™ First Followed by Alendronate vs Alendronate Alone1,3
BMD Gains at 12, 24, and 36 Months

LUMBAR SPINE

Lumbar Spine. Change from baseline (%)

*Number of subjects with values at baseline and at least one post-baseline visit at or before month 36.

P < 0.001 based on ANCOVA model using last-observation-carried-forward (LOCF) adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.

TOTAL HIP

Total Hip. Change from baseline (%)

*Number of subjects with values at baseline and at least one post-baseline visit at or before month 36.

P < 0.001 based on ANCOVA model using last-observation-carried-forward (LOCF) adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.

FEMORAL NECK

Femoral Neck. Change from baseline (%)

*Number of subjects with values at baseline and at least one post-baseline visit at or before month 36.

P < 0.001 based on ANCOVA model using last-observation-carried-forward (LOCF) adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.

EVENITY™ VS PLACEBO EFFICACY EVENITY™ VS TERIPARATIDE EFFICACY

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH
EVENITY™ may increase the risk of myocardial infarction, stroke and cardiovascular death. 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. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY™ should be discontinued.

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References: 1. EVENITY™ (romosozumab-aqqg) prescribing information, Amgen. 2. van Geel TA, van Helden S, Geusens PP, Winkens B, Dinant GJ. Clinical subsequent fractures cluster in time after first fractures. Ann Rheum Dis. 2009;68:99-102. 3. Saag KG, Petersen J, Brandi ML, et al. Romosozumab or alendronate for fracture prevention in women with osteoporosis. N Engl J Med. 2017;377:1417-1427.