II. Indications
-
Osteoporosis Management (Vertebral, non-Vertebral)
- Moderate to High Risk for Fragility Fracture
- Osteoporosis-Related Vertebral Spine Fractures
- Consider in men with high Fracture risk secondary to androgen deprivation therapy (for Prostate Cancer)
- Preferred Osteoporosis agent in Chronic Kidney Disease stage 4 to 5
- Bisphosphonates are contraindicated in advanced renal disease
III. Mechanism
-
Monoclonal Antibody blocks Osteoclast activity
- Acts at nuclear factor kappa B Ligand activator receptor
IV. Dosing
- Dose: 60 mg SQ every 6 months
V. Adverse Effects
- Cost $2600 per year in 2020
- Increased risk of infection
- Jaw Osteonecrosis (rare)
- Atypical Femur Fracture
- Risk of rebound Vertebral Fractures when stopped or dose delayed
- Switch to bisphosphonate when Denosumab course completed
-
Hypocalcemia (2%)
- Reduces Calcium mobilization from bone
- Hypocalcemia may be severe and life threatening
- Higher risk in severe renal disease (esp. Hemodialysis patients)
- Maintain Calcium Supplementation 1000 mg and Vitamin D 400 IU per day while on Denosumab
- Monitor Serum Calcium, Serum Phosphorus and Parathyroid Hormone within 2 weeks of dose change
- Resources
VI. References
- (2023) Presc Lett 30(2): 12
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Related Studies
prolia (on 7/1/2022 at Medicaid.Gov Survey of pharmacy drug pricing) | ||
PROLIA 60 MG/ML SYRINGE | $1,428.42 per ml |
Ontology: denosumab (C1690432)
Definition (NCI) | A fully human monoclonal antibody directed against the receptor activator of nuclear factor kappa beta ligand (RANKL) with antiosteoclast activity. Denosumab specifically binds to RANKL and blocks the interaction of RANKL with RANK, a receptor located on osteoclast cell surfaces, resulting in inhibition of osteoclast activity, a decrease in bone resorption, and a potential increase in bone mineral density. RANKL, a protein expressed by osteoblastic cells, plays an important role in osteoclastic differentiation and activation. |
Definition (NCI_NCI-GLOSS) | A type of monoclonal antibody being studied in the treatment of multiple myeloma (a cancer that forms in bones) and in the prevention and treatment of bone metastases (cancer that has spread to bone from another organ). Monoclonal antibodies are made in the laboratory and can locate and bind to substances in the body, including cancer cells. AMG 162 binds to the protein RANKL and helps keep bone from breaking down. |
Definition (PDQ) | A humanized monoclonal antibody directed against the receptor activator of nuclear factor kappa beta ligand (RANKL) with antiosteoclast activity. Denosumab specifically binds to RANKL and blocks the interaction of RANKL with RANK, a receptor located on osteoclast cell surfaces, resulting in inhibition of osteoclast activity, a decrease in bone resorption, and a potential increase in bone mineral density. RANKL, a protein expressed by osteoblastic cells, plays an important role in osteoclastic differentiation and activation. Check for "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=481348&idtype=1" active clinical trials or "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=481348&idtype=1&closed=1" closed clinical trials using this agent. ("http://nciterms.nci.nih.gov:80/NCIBrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C61313" NCI Thesaurus) |
Concepts | Amino Acid, Peptide, or Protein (T116) , Immunologic Factor (T129) , Pharmacologic Substance (T121) |
MSH | C494392 |
SnomedCT | 446321003, 446457007 |
English | Densosumab, DENOSUMAB, Denosumab, Denosumab (substance), Denosumab (product), denosumab, denosumab (medication) |
Spanish | denosumab, denosumab (producto), denosumab (sustancia) |
Ontology: Prolia (C2917754)
Concepts | Pharmacologic Substance (T121) |
MSH | C494392 |
English | Prolia |