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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

Prolia® is the only FDA-approved therapy for cancer treatment–induced bone loss (CTIBL) due to hormone ablation therapy (CTIBL-HALT).1

Prolia®: The only FDA-approved therapy for breast cancer treatment–induced bone loss due to AI therapy

“We investigated the ability of denosumab, a fully human* monoclonal antibody against [RANK Ligand], to protect against aromatase inhibitor–induced bone loss.”

—Ellis GK, et al2

*Correlation with safety and efficacy is unknown.

Indication: 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.1
Pivotal Trial (CTIBL-HALT)

Study design (CTIBL-HALT)1,2

A 2-year, randomized, multinational, double-blind, phase 3 study assessing the effects of Prolia® vs placebo on BMD

  • Patients were instructed to take ≥ 1,000 mg of calcium and ≥ 400 IU of vitamin D supplementation daily.

Study endpoints2

Primary endpoint:
  • Percent change in:
    • Lumbar spine BMD from baseline to 12 months
Exploratory endpoints:
  • Percent change in:
    • Lumbar spine BMD from baseline to 24 months
    • Total hip BMD from baseline to 24 months
    • Femoral neck BMD from baseline to 24 months
  • CTIBL-HALT=cancer treatment–induced bone loss due to hormone ablation therapy.