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

Pivotal trial with a primary endpoint of 12-month vertebral fracture1

Phase 3 Study in Postmenopausal Women With Osteoporosis Receiving
EVENITY™ First Followed by Prolia® (denosumab) vs Placebo Followed
by Prolia®1,2

FRAME Study Design

SC = subcutaneous; QM = monthly; Q6M = every 6 months.

Randomized, double-blind, placebo-controlled study1

  • Postmenopausal women, 55 to 90 years old
  • Bone mineral density (BMD) T-score ≤ -2.5 at total hip or femoral neck

7180 women randomized to receive 12 months of treatment1

  • Subcutaneous injections of EVENITY™ (n = 3589), or
  • Placebo (n = 3591)

All women supplemented with daily calcium and vitamin D

After 12-month treatment period, women in both arms transitioned to open-label antiresorptive therapy (denosumab) for 12 months while remaining blinded to their initial treatment

Co-primary endpoints1

  • New vertebral fracture at month 12 and month 24

STUDY ENDPOINTS

Co-primary Endpoints1

  • New vertebral fracture at 12 and 24 months

Secondary Endpoints2

  • Cumulative incidence of clinical (nonvertebral and symptomatic vertebral), nonvertebral, and other fractures* at 12 and 24 months

Additional Endpoints2

  • Change from baseline in BMD at lumbar spine, total hip, and femoral neck at 12 and 24 months

*Other fractures: major nonvertebral fracture, new or worsening vertebral fracture, hip fracture, major osteoporotic fracture, and multiple new or worsening vertebral fractures.

STUDY POPULATION

Inclusion Criteria1,2

  • Postmenopausal women age 55 to 90 years
  • BMD T-score ≤ -2.5 at the total hip or femoral neck
  • At least two vertebrae in the L1 through L4 region and at least one hip that could be evaluated by means of dual-energy x-ray absorptiometry

Select Exclusion Criteria2,*

  • BMD T-score ≤ -3.5 at the total hip or femoral neck
  • History of hip fracture, any severe vertebral fracture, or more than 2 moderate vertebral fractures
  • Recent osteoporosis therapy

Baseline Characteristics1,2

  • Mean age: 71 years
  • Fracture history: 18.3% with prevalent vertebral fracture (most were mild in severity); 21.8% with previous nonvertebral fracture
  • Mean BMD T-scores: -2.72 (lumbar spine), -2.47 (total hip), -2.75 (femoral neck)

*Other exclusion criteria: history of metabolic bone disease or conditions affecting bone metabolism, osteonecrosis of the jaw, a 25-hydroxyvitamin D level of less than 20 ng per milliliter, current hypercalcemia or hypocalcemia.

EVENITY™ VS ALENDRONATE STUDY DESIGN EVENITY™ VS TERIPARATIDE 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. EVENITY™ (romosozumab-aqqg) prescribing information, Amgen. 2. Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med. 2016;375:1532-1543.