Denosumab

(Prolia)

Denosumab

Drug updated on 8/24/2023

Dosage FormInjection (subcutaneous; 60 mg)
Drug ClassRANK ligand (RANKL) inhibitor
Ongoing and Completed StudiesClinicalTrials.gov

Indication

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

Product Monograph / Prescribing Information

Document TitleYearSource
Prolia (denosumab) Prescribing Information.2023Amgen Inc., Thousand Oaks, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Denosumab versus bisphosphonates for reducing fractures in postmenopausal women with osteoporosis: a meta-analysis.2023Journal of the American Board of Family Medicine
Efficacy of the combination of teriparatide and denosumab in the treatment of postmenopausal osteoporosis: a meta-analysis.2022Frontiers in Pharmacology
The efficacy of denosumab in patients with rheumatoid arthritis: a systematic review and pooled analysis of randomized or matched data.2022Frontiers in Immunology
Comparison of denosumab and oral bisphosphonates for the treatment of glucocorticoid-induced osteoporosis: a systematic review and meta-analysis.2022BMC Musculoskeletal Disorders
Is denosumab associated with an increased risk for infection in patients with low bone mineral density? A systematic review and meta-analysis of randomized controlled trials.2021International Journal of Rheumatic Diseases
Denosumab improves glucose parameters in patients with impaired glucose tolerance: a systematic review and meta-analysis.2021Journal of Drug Assessment
Risk for Infections during treatment with denosumab for osteoporosis: a systematic review and meta-analysis.2020The Journal of Clinical Endocrinology & Metabolism
Denosumab is not associated with risk of malignancy: systematic review and meta-analysis of randomized controlled trials.2020Osteoporosis International
Fracture risk and management of discontinuation of denosumab therapy: a systematic review and position statement by ECTS.2020The Journal of Clinical Endocrinology & Metabolism
Denosumab or romosozumab therapy and risk of cardiovascular events in patients with primary osteoporosis: systematic review and meta- analysis.2020Bone
Denosumab compared to bisphosphonates to treat postmenopausal osteoporosis: a meta-analysis.2018Journal of Orthopaedic Surgery and Research
Comparison of denosumab and bisphosphonates in patients with osteoporosis: a meta-analysis of randomized controlled trials.2018The Journal of Clinical Endocrinology & Metabolism

Clinical Practice Guidelines