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 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

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

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.