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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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Androgen deprivation therapy (ADT) can result in bone loss1,2

  • Testosterone molecule for illustration purposes only.

Bone Mineral Density (BMD)

Comparison of ADT-induced BMD loss vs. normal BMD loss in men and women

Comparison of ADT-induced BMD loss vs. normal BMD loss in men and women. See references (1,2) below. Comparison of ADT-induced BMD loss vs. normal BMD loss in men and women. See references (1,2) below.
Reference data are obtained from population-based or review articles that measured bone loss at different sites (eg. lumbar spine or total hip).1,2
Patients with prostate cancer receiving ADT lost up to 4% BMD at the posteroanterior spine in the first year of therapy alone.2
Calcium and vitamin D supplementation alone may not be sufficient to prevent bone loss and fractures in patients receiving ADT.3

ADT is associated with fracture risk

Fracture: Percent of patients with a fracture, 12 to 60 months after diagnosis of prostate cancer

Percent of patients with a fracture, 12 to 60 months after diagnosis of prostate cancer. See reference (4) below. Percent of patients with a fracture, 12 to 60 months after diagnosis of prostate cancer. See reference (4) below.
Data from a bone-related toxic effect subanalysis (n=26,685) of a study analyzing men listed in the linked database of the National Cancer Institute’s Surveillance, Epidemiology, and End Results program and Medicare as having received a diagnosis of prostate cancer over a 12- to 60-month period. ADT included gonadotropin-releasing hormone (GnRH) agonist therapy or orchiectomy.4
Data have shown that nearly 1 in 5 men receiving multiple doses of ADT experienced a fracture within 4 years after the first year of diagnosis.4
Patients with prostate cancer receiving ADT experienced a 54% increase in relative incidence of fractures compared with patients not receiving ADT.4
Calcium and vitamin D supplementation alone may not be sufficient to prevent bone loss and fractures in patients receiving ADT.3