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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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Aromatase inhibitor (AI) therapy puts women at high risk for fracture1

AI therapy results in estrogen depletion, leading to lower bone mineral density (BMD) and increased fracture risk.1

  • Estrogen molecule for illustration purposes only.

BMD: The most pronounced rate of bone loss at the lumbar spine, measured by BMD, occurs within the first year of AI therapy (-2.3%)2,3

Median Percent Change in Lumbar Spine BMD From Baseline. See references (2,3) below.
Data from a randomized, double-blind, multicenter, prospective substudy performed within the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial assessing BMD changes at the lumbar spine and total hip in postmenopausal women with nonmetastatic breast cancer receiving anastrozole or tamoxifen therapy.2,3
Calcium and vitamin D supplementation alone may not be sufficient to prevent bone loss and fractures in patients receiving AI therapy4

Fracture: Patients with breast cancer receiving AI therapy are more likely to experience a fracture than those not receiving AI therapy5

Incidence Rate of Fracture (per 100 person-years). See reference (5) below. Incidence Rate of Fracture (per 100 person-years). See reference (5) below.
Data from a claims-based retrospective cohort study conducted from 1998 to 2005, involving patients with breast cancer, without bone metastases and no previous osteoporosis, or fracture claims, receiving AI therapy (n = 1354) versus those not receiving AI therapy (n = 11,014).5
RR=relative risk.
Calcium and vitamin D supplementation alone may not be sufficient to prevent bone loss and fractures in patients receiving AI therapy4