Denosumab

(Prolia®)

Prolia®

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Drug updated on 4/17/2024

Dosage FormInjection (subcutaneous; 60 mg)
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.

Summary
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  • Denosumab (Prolia) is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, men with osteoporosis at high risk for fracture, glucocorticoid-induced osteoporosis in both genders at high risk for fracture, and to increase bone mass in men receiving androgen deprivation therapy for nonmetastatic prostate cancer or women receiving adjuvant aromatase inhibitor therapy for breast cancer.
  • Forty-six studies focused on denosumab's application in various conditions related to bone density and fractures. These included randomized controlled trials, meta-analyses, and systematic reviews.
  • Compared to bisphosphonates, denosumab has been effective in increasing bone mineral density more significantly but did not demonstrate a reduction in clinical or osteoporotic fractures compared with bisphosphonates, suggesting its use is more costly without added benefits.
  • In glucocorticoid-induced osteoporosis (GIO), denosumab outperformed bisphosphonates and teriparatide by increasing lumbar spine and femur neck BMD while reducing vertebral fractures.
  • For postmenopausal women specifically, studies support that denosumab effectively enhances BMD and potentially reduces fracture risks over bisphosphonates while maintaining similar safety profiles.
  • Men suffering from osteoporosis have seen an increase in their bone mass after using denosumab; this also applies to those undergoing androgen deprivation therapy due to non-metastatic prostate cancer, indicating broad applicability across genders.
  • Denosumab was found beneficial even among patients having renal impairment where it improved BMD without significant changes in serum calcium or phosphate levels, although careful monitoring is advised against hypocalcemia.
  • Denosumab is associated with a higher incidence of osteonecrosis of the jaw (ONJ) and hypocalcemia compared to bisphosphonates, especially in cancer patients receiving higher doses for bone metastasis control. Concerns were also raised regarding its association with atypical femoral fractures (AFF), particularly following long-term use or after treatment discontinuation.

Product Monograph / Prescribing Information

Document TitleYearSource
Prolia (denosumab) Prescribing Information.2024Amgen Inc., Thousand Oaks, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Anti-osteoporotic drug efficacy for periprosthetic bone loss after total hip arthroplasty: a systematic review and network meta-analysis.2024Journal of Orthopaedic Science
Denosumab, teriparatide and bisphosphonates for glucocorticoid-induced osteoporosis: a Bayesian network meta-analysis.2024Frontiers in Pharmacology
Denosumab versus bisphosphonates for reducing fractures in postmenopausal women with osteoporosis: a meta-analysis.2023Journal of the American Board of Family Medicine
Effects of denosumab on bone mineral density and bone metabolism in patients with end-stage renal disease: a systematic review and meta-analysis.2023Hemodialysis International
The clinical effectiveness of denosumab (Prolia®) for the treatment of osteoporosis in postmenopausal women, compared to bisphosphonates, selective estrogen receptor modulators (SERM), and placebo: a systematic review and network meta-analysis.2023Calcified Tissue International
Clinical efficacy of denosumab, teriparatide, and oral bisphosphonates in the prevention of glucocorticoid-induced osteoporosis: a systematic review and meta-analysis.2023Journal of Orthopaedic Surgery & Research
Adjuvant denosumab in early breast cancer: a systematic review and meta-analysis of randomized controlled clinical trials.2023Therapeutic Advances in Medical Oncology
Incidence rate of osteonecrosis of jaw after cancer treated with bisphosphonates and denosumab: a systematic review and meta-analysis.2023Special Care in Dentistry
Drug efficacy and safety of denosumab, teriparatide, zoledronic acid, and ibandronic acid for the treatment of postmenopausal osteoporosis: a network meta-analysis of randomized controlled trials.2023European Review for Medical and Pharmacological Sciences
Efficacy of antiresorptive agents in fibrous dysplasia and McCune Albright syndrome, a systematic review and meta-analysis.2023Reviews in Endocrine & Metabolic Disorders
Zoledronic acid and denosumab for periprosthetic bone mineral density loss after joint arthroplasty: a systematic review and meta-analysis of randomized controlled trials.2023Archives of Osteoporosis
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
A systematic review and meta-analysis of interventional studies of bisphosphonates and denosumab in multiple myeloma and future perspectives.2022Journal of Musculoskeletal & Neuronal Interactions
Unresectable clival giant cell tumor, tumor control with denosumab after relapse: a case report and systematic review of the literature.2022Journal of Pediatric Hematology/Oncology
Safety of denosumab versus zoledronic acid in the older adults with osteoporosis: a meta-analysis of cohort studies.2022Archives of Osteoporosis
Importance of time point-specific indirect treatment comparisons of osteoporosis treatments: a systematic literature review and network meta-analyses.2022Clinical Therapeutics
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
Hypercalcemia following discontinuation of denosumab therapy: a systematic review.2021Bone Reports
Therapeutic efficacy of denosumab for rheumatoid arthritis: a systematic review and meta-analysis.2021Rheumatology Advances in Practice
The role of denosumab for surgical outcomes in patients with giant cell tumour of bone: a systematic review.2021Current Oncology
Meta-analysis of clinical trials to assess denosumab over zoledronic acid in bone metastasis.2021International Journal of Clinical Pharmacy
Comparison of denosumab and zoledronic acid for the treatment of solid tumors and multiple myeloma with bone metastasis: a systematic review and meta-analysis based on randomized controlled trials.2021Journal of Orthopaedic Surgery & Research
Differences between bisphosphonate-related and denosumab-related osteonecrosis of the jaws: a systematic review.2021Support Care in Cancer
Cardiovascular safety of denosumab across multiple indications: a systematic review and meta-analysis of randomized trials.2021Journal of Bone and Mineral Research
Preoperative denosumab may increase the risk of local recurrence of giant-cell tumor of bone treated with curettage: a systematic review and meta-analysis.2021Journal of Cancer
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 for effective tumor size reduction in patients with giant cell tumors of the bone: a systematic review and meta-analysis.2020Cancer Control
Clinical effectiveness of denosumab, raloxifene, romosozumab, and teriparatide for the prevention of osteoporotic fragility fractures: a systematic review and network meta-analysis.2020Bone
Pre-operative denosumab is associated with higher risk of local recurrence in giant cell tumor of bone: a systematic review and meta-analysis.2020BMC Musculoskeletal Disorders
Osteoporosis drugs for prevention of clinical fracture in white postmenopausal women: a network meta-analysis of survival data.2020Osteoporosis International
Risk for infections during treatment with denosumab for osteoporosis: a systematic review and meta-analysis.2020Journal of Clinical Endocrinology and Metabolism
Is treatment with denosumab associated with local recurrence in patients with giant cell tumor of bone treated with curettage? A systematic review.2020Clinical Orthopaedics and Related Research
Denosumab versus zoledronic acid in the prevention of skeletal-related events in vulnerable cancer patients: a meta-analysis of randomized, controlled trials.2020Clinical Therapeutics
Bisphosphonates versus denosumab for prevention of pathological fracture in advanced cancers with bone metastasis: a meta-analysis of randomized controlled trials.2020Journal of the American Academy of Orthopaedic Surgeons, Global Research & Reviews
Medical management of patients after atypical femur fractures: a systematic review and recommendations from the European Calcified Tissue Society.2020The Journal of Clinical Endocrinology & Metabolism
Atypical femoral fracture in patients with bone metastasis receiving denosumab therapy: a retrospective study and systematic review.2019BMC Cancer
Denosumab for bone health in prostate and breast cancer patients receiving endocrine therapy? A systematic review and a meta-analysis of randomized trials.2019Journal of Bone Oncology
Denosumab in the treatment of glucocorticoid-induced osteoporosis: a systematic review and meta-analysis.2019Drug Design, Development and Therapy
Denosumab treatment for giant-cell tumor of bone: a systematic review of the literature.2019Archives of Ortopaedic and Trauma Surgery
Comparison of denosumab and bisphosphonates in patients with osteoporosis: a meta-analysis of randomized controlled trials.2019Journal of Clinical Endocrinology and Metabolism
Effects of denosumab on bone metabolism and bone mineral density in kidney transplant patients: a systematic review and meta-analysis.2019Archives of Osteoporosis

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