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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®: Significant increase in BMD

Primary Endpoint

12 Months: 5.5% increase in BMD at the lumbar spine compared with placebo at 12 months (P< 0.0001)1

Prolia®: long-term increases in BMD at key measured sites2

Exploratory Endpoints

24 Months: Prolia® demonstrated a continued increase in BMD through 24 months1

Mean Percent Change in Lumbar Spine BMD at 24 Months. See references (1,2) below.
  • Total Hip
  • Femoral Neck

Mean Percent Change in Total Hip BMD at 24 Months. See references (1,2) below.

CTIBL-HALT=cancer treatment–induced bone loss due to hormone ablation therapy.

Mean Percent Change in Femoral Neck BMD at 24 Months. See references (1,2) below.

CTIBL-HALT=cancer treatment–induced bone loss due to hormone ablation therapy.