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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 the treatment of postmenopausal women with osteoporosis at high risk for fracture

Prolia® is proven to significantly reduce fracture risk at vertebral, hip, and nonvertebral sites at 3 years1,2

  • Vertebral
  • Hip/Nonvertebral

Vertebral Fracture Relative Risk Reduction vs Placebo1,2*

Verterbral Fracture Relative Risk Reduction vs Placebo. See references (1,2) below
Primary Endpoint: Incidence of new vertebral fractures
at 3 years

Results of 3 years in a pivotal phase 3 fracture trial of 7808 women with postmenopausal osteoporosis1,2

Fracture Relative Risk Reduction vs Placebo1,2*

Hip/Nonvertebral Fracture Relative Risk Reduction vs Placebo. See references (1,2) below.

Secondary endpoint results from 3 years in a pivotal phase 3 fracture trial of 7808 women with postmenopausal osteoporosis1,2

Prolia® reduced the incidence of new vertebral fracture in patients with or without a baseline vertebral fracture1,2

  • In the pivotal phase 3 fracture trial, 1 in 4 patients had a baseline vertebral fracture2

No overall differences in the efficacy and safety of Prolia® were observed between younger patients and patients aged 75 or older1

  • Of the total number of patients in clinical studies of Prolia®, 9943 (76%) were ≥ 65 years old, and 3576 (27%) were ≥ 75 years old1
  • *Includes 7393 patients with a baseline and at least one post-baseline radiograph.1,2
  • Relative risk reduction.
  • Absolute risk reduction.
  • *Includes 7393 patients with a baseline and at least one post-baseline radiograph.1,2
  • Relative risk reduction.
  • Absolute risk reduction.
  • §Secondary endpoints were time to first nonvertebral and hip fracture, assessed at 3 years.
  • Composite measurement excluding pathological fractures and those associated with severe trauma, fractures of the vertebrae, skull, face, mandible, metacarpals, fingers, and toes.1,2

PIVOTAL phase 3 study design: Multicenter, international, randomized, double-blind, placebo-controlled clinical trial. Patients were postmenopausal women between 60 and 91 years of age with a BMD T-score between -2.5 and -4.0 at the lumbar spine or total hip. 7808 patients were randomized to receive Prolia® 60 mg (n = 3902) or placebo (n = 3906) subcutaneously (SC) every 6 months (Q6M). All patients were supplemented with daily calcium and vitamin D.1,2

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®.

Prolia® demonstrated BMD increases in the pivotal phase 3 fracture trial1

  • Total Hip
  • Lumbar Spine
  • Femoral Neck

Significant Increase in Total Hip BMD at 3 Years1,3

Increase in Total Hip BMD at 3 Years. See references (1,3) below.
6.4%||
Difference
in BMD
  • Prolia® (n = 3902)
  • Placebo (n = 3906)
  • ||p < 0.0001, when compared to placebo.

Significant Increase in Lumbar Spine BMD at 3 Years1,2

Increase in Lumbar Spine BMD at 3 Years. See references (1,2) below.
8.8%
Difference
in BMD
  • Prolia® (n = 3902)
  • Placebo (n = 3906)

Significant Increase in Femoral Neck BMD at 3 Years1,2

Increase in Femoral Neck BMD at 3 Years. See references (1,2) below.
5.2%
Difference
in BMD
  • Prolia® (n = 3902)
  • Placebo (n = 3906)
  • Prolia® increased bone mass and strength in both cortical and trabecular bone1
  • Prolia® patient bone biopsies showed normal bone architecture and quality1#
#53 bone biopsy specimens taken from transiliac crest.1

Important Safety Information

Hypocalcemia may worsen with the use of Prolia®, especially in patients with severe renal impairment. Adequately supplement all patients with calcium and vitamin D.