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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®: Proven to reduce fracture risk by half vs placebo1

Primary Endpoint

In women with nonmetastatic breast cancer being treated with an AI, Prolia® delayed the time to first clinical fracture by 50% compared to placebo1

Percentage risk of fracture based on Kaplan-Meier time-to-event analysis within each treatment group at 6-month intervals1

Percentage risk of fracture based on Kaplan-Meier time-to-event analysis within each treatment group at 6-month intervals. See reference (1) below. Percentage risk of fracture based on Kaplan-Meier time-to-event analysis within each treatment group at 6-month intervals. See reference (1) below.
The hazard ratio and P value were calculated from a Cox model including treatment groups as the independent variable and stratified by the randomization stratification factors. Error bars are 95% confidence intervals
Prolia® reduced first clinical fracture rate at 7 years1
  • 11.1% in the Prolia® group vs 26.2% in the placebo group

Prolia®: Significantly reduced the incidence of new vertebral fractures1

Secondary Endpoints
Incidence of vertebral fractures at 36 months. See reference (1) below. Incidence of vertebral fractures at 36 months. See reference (1) below.