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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 for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, 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.

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Prolia® is the only FDA-approved therapy for cancer treatment–induced bone loss (CTIBL) due to hormone ablation therapy (CTIBL-HALT)1

Prolia®: Sustained reduction of new vertebral fractures up to 36 months2

Prolia® significantly decreased the incidence of new vertebral fractures up to 36 months1,2

62% relative risk reduction in the incidence of new vertebral fractures at 36 months (P= 0.0125, adjusted for age group and ADT duration variables).1

Relative risk reduction of new vertebral fracture at 12, 24, and 36 months1,3
Relative risk reduction of new vertebral fracture at 12, 24, and 36 months. See references (1,3) below. Relative risk reduction of new vertebral fracture at 12, 24, and 36 months. See references (1,3) below.
  • * ARR = absolute risk reduction.