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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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Now Approved for 5 Indications

As of May 2018, Prolia® (denosumab) is approved for a new indication.
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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.