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Denosumab

(Prolia®)

Prolia®

Drug updated on 11/1/2024

Dosage FormInjection (subcutaneous; 60 mg/mL )
Drug ClassRANK ligand (RANKL) inhibitors
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture
  • Indicated for the treatment to increase bone mass in men with osteoporosis at high risk for fracture
  • Indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
  • Indicated for the treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
  • Indicated for the treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

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Summary
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  • This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
  • Bone Mineral Density (BMD) and Fracture Reduction: Denosumab was associated with significant increases in BMD and reduction in vertebral, hip, and non-vertebral fractures compared to placebo and bisphosphonates. It demonstrated the highest effectiveness in increasing total hip BMD and preventing secondary osteoporotic vertebral compression fractures in network meta-analysis.
  • Falls Reduction: Denosumab significantly reduced the incidence of non-fracture-related falls (HR (hazard ratio) = 0.79; 95% CI (confidence interval) 0.66-0.93; p = 0.0061) in women with postmenopausal osteoporosis, men with osteoporosis, and cancer patients on specific therapies.
  • Comparative Effectiveness: Denosumab ranked highest in increasing total hip BMD (SUCRA (surface under the cumulative ranking curve) 99.7%) and was effective across various populations, including postmenopausal women, men with osteoporosis, cancer patients, and those with glucocorticoid-induced osteoporosis (GIOP).
  • Denosumab treatment was associated with an increased risk of any infection (RR (relative risk) 1.11; 95% CI 1.02-1.20; P = 0.02) compared with bisphosphonates, but not placebo. Additionally, there was a higher incidence of serious adverse events of infection (SAEI) (RR 1.21; 95% CI 1.03-1.43; P = 0.02) in denosumab-treated patients compared to placebo, though not bisphosphonates.
  • Compared to other osteoporosis drugs, denosumab had fewer gastrointestinal complaints and led to fewer discontinuations due to adverse events.