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Indications

Prolia® is indicated for the treatment of postmenopausal women with osteoporosis 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. In postmenopausal Read More

Prolia® is indicated for the treatment of postmenopausal women with osteoporosis 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. In postmenopausal women with osteoporosis, Prolia® reduces the incidence of vertebral, nonvertebral, and hip fractures.

Prolia® is indicated for treatment to increase bone mass in men with osteoporosis 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.

Prolia® is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Prolia® also reduced the incidence of vertebral fractures.

Prolia® is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Close

7808
WOMEN

PIVOTAL phase 3 study design1,2

Multicenter, international, randomized, double-blind, placebo-controlled clinical trial. Patients were postmenopausal women between 60 and 91 years of age with a BMD T-score between -2.5 and -4.0 at the lumbar spine or total hip.

7808 patients were randomized to receive Prolia® 60 mg (n = 3902) or placebo (n = 3906) subcutaneously (SC) every 6 months (Q6M). All patients were supplemented with daily calcium and vitamin D.

The primary endpoint was incidence of new vertebral fractures at 3 years, and secondary endpoints were time to first nonvertebral and hip fracture.1,2