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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 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. Close

PHASE
3

Pivotal Study Design1,2*

An international, multicenter, randomized, phase 3 study to compare the efficacy and safety of denosumab vs placebo in males with osteoporosis. The study was double-blind and placebo-controlled. Eligible subjects were randomized to receive either 60 mg denosumab or placebo as a subcutaneous (SC) injection once every 6 months (Q6M) over a 12-month period at day 1 and month 6.

All patients were supplemented with calcium and vitamin D. The primary endpoint was percent change from baseline in lumbar spine BMD at month 12, and secondary endpoints included percent change from baseline in total hip BMD at month 12.1,2*

*After the 12-month, double-blind treatment, all continuing subjects received open-label 60 mg Q6M SC denosumab for 12 more months.1,2

Prolia® has been proven to help increase bone mass in a pivotal phase 3 trial in men with osteoporosis1,2

STUDY OBJECTIVE
To investigate the effects of denosumab compared with placebo in men with low BMD after 1 year of treatment1,2
PRIMARY ENDPOINT
Percent change from baseline in lumbar spine BMD at 12 months1,2
SELECT SECONDARY ENDPOINTS
Percent change from baseline in BMD of the total hip and femoral neck at month 121,2

Important Safety Information

Clinically significant hypersensitivity including anaphylaxis has been reported with Prolia®. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue Prolia®.