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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

For treatment to increase bone mass in men with osteoporosis at high risk for fracture

Prolia® resulted in significant increases in BMD at lumbar spine and total hip1,2

Percent Change from Baseline (BL) in Lumbar Spine BMD at 12 Months2

Percent Change from Baseline in Lumbar Spine BMD at 12 Months. See reference (2) below.
4.8%
Difference
in BMD
  • Prolia® (n = 117)
  • Placebo (n = 117)
  • *p < 0.0001 vs placebo.
  • Difference between Prolia® and placebo is calculated with treatment group as main effect and baseline BMD T-score as covariate.

PIVOTAL phase 3 study design: 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

Important Safety Information

ONJ and atypical femoral fracture have been reported in patients with Prolia®. The risk of ONJ may increase with duration of exposure to Prolia®. Patients should be monitored for adverse outcomes.

Percent Change from Baseline (BL) in Total Hip BMD at 12 Months2

Percent Change from Baseline in Total Hip BMD at 12 Months. See reference (2) below.
2.0%
Difference
in BMD
  • Prolia® (n = 117)
  • Placebo (n = 117)
  • *p < 0.0001 vs placebo.
  • Difference between Prolia® and placebo is calculated with treatment group as main effect and baseline BMD T-score as covariate.

PIVOTAL phase 3 study design: 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

Important Safety Information

ONJ and atypical femoral fracture have been reported in patients with Prolia®. The risk of ONJ may increase with duration of exposure to Prolia®. Patients should be monitored for adverse outcomes.