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

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
PRESCRIBING INFORMATION MEDICATION GUIDE IMPORTANT SAFETY INFORMATION INDICATION FOR PATIENTS CONNECT WITH A REP

EVENITY® VS TERIPARATIDE (STRUCTURE)

Active-controlled BMD study vs teriparatide in women with postmenopausal osteoporosis at high risk of fracture transitioning from oral bisphosphonates1

EVENITY® compared to the most commonly used bone builder through 12 months1

Phase 3 Study in Postmenopausal Women With Osteoporosis Receiving EVENITY® vs Teriparatide1

STRUCTURE Study Design

SC = subcutaneous; QM = monthly; QD = once daily.

Randomized, open-label study1

  • Postmenopausal women, 55 to 90 years old
  • Had osteoporosis and history of nonvertebral fracture after age 50 or vertebral fracture at any time
  • Patients were receiving oral bisphosphonates at least 3 years prior to enrollment

436 women transitioned from bisphosphonate therapy to1

  • EVENITY®, or
  • Teriparatide

All women supplemented with daily calcium and vitamin D

Primary endpoint1

  • Percent change from baseline in total hip BMD through month 12 (mean of months 6 and 12)

Consider open-label study limitations when interpreting results. This open-label study was not blinded.

STUDY ENDPOINTS

Primary Endpoint1

  • Percent change from baseline in total hip BMD through month 12 (mean of months 6 and 12)

Secondary Endpoints1

  • Percent change from baseline:
    • BMD by DXA at total hip, femoral neck, and lumbar spine at months 6 and 12
    • Cortical and integral volumetric BMD by QCT at hip at months 6 and 12
    • Estimated hip strength by finite element analysis at months 6 and 12

Exploratory Endpoint1

  • The percentage change from baseline in bone turnover markers (P1NP and CTX)

QCT = quantitative computed tomography.

STUDY POPULATION

Inclusion Criteria1

  • Postmenopausal women age 55 to 90 years
  • Patients had received oral bisphosphonates for at least 3 years before screening and alendronate the year immediately before screening
  • Patients had a history of nonvertebral fracture after age 50 years or vertebral fracture
  • BMD T-score ≤ -2.5 at total hip, femoral neck, or lumbar spine
  • At least one hip and at least two vertebrae in the L1–L4 region

Exclusion Criteria1

  • Contraindications or signs of intolerance to teriparatide
  • Recent use of agents affecting bone metabolism
  • A serum 25-hydroxyvitamin D concentration of less than 50 nmol/L
  • A history of metabolic or bone disease or other disease or conditions know to affect bone mass

Baseline Characteristics1

  • Mean age: 71.8 years in EVENITY® group, 71.2 years in teriparatide group
  • Fracture history: 100% of patients had experienced a previous fracture
  • Mean BMD T-scores: -2.83 (lumbar spine), -2.27 (total hip), -2.49 (femoral neck) in EVENITY® group; -2.87, -2.21, -2.43, respectively, in teriparatide group
  • 100% of patients had used oral bisphosphonates in 3 years before screening with median use of 6.2 years1
EVENITY® VS ALENDRONATE STUDY DESIGN EVENITY® VS PLACEBO STUDY DESIGN

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.

In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY® compared to those treated with alendronate.

Contraindications: EVENITY® is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY®. EVENITY® is contraindicated in patients with a history of systemic hypersensitivity to romosozumab or to any component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria.

Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria have occurred in EVENITY®-treated patients. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of EVENITY®.

Hypocalcemia: Hypocalcemia has occurred in patients receiving EVENITY®. Correct hypocalcemia prior to initiating EVENITY®. Monitor patients for signs and symptoms of hypocalcemia, particularly in patients with severe renal impairment or receiving dialysis. Adequately supplement patients with calcium and vitamin D while on EVENITY®.

Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving EVENITY®. A routine oral exam should be performed by the prescriber prior to initiation of EVENITY®. Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, and corticosteroids) may increase the risk of developing ONJ. Other risk factors for ONJ include cancer, radiotherapy, poor oral hygiene, pre-existing dental disease or infection, anemia, and coagulopathy.

For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. In these patients, dental surgery to treat ONJ may exacerbate the condition. Discontinuation of EVENITY® should be considered based on benefit-risk assessment.

Atypical Femoral Fractures: Atypical low-energy or low trauma fractures of the femoral shaft have been reported in patients receiving EVENITY®. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated.

During EVENITY® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Interruption of EVENITY® therapy should be considered based on benefit-risk assessment.

Adverse Reactions: The most common adverse reactions (≥ 5%) reported with EVENITY® were arthralgia and headache.

EVENITY® is a humanized monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.

Please see EVENITY® full Prescribing Information, including Medication Guide.

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. Langdahl BL, Libanati C, Crittenden DB, 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;390:1585-1594.