DENOSUMAB-DESU INJ,SOLN

Exclusion Criteria

• Hypocalcemia or pre-existing disturbance of mineral metabolism not effectively corrected or treated
• Documentation of need for invasive dental procedure (e.g., tooth extraction, dental implant, dental infection treatment) or recent unhealed procedure
• Acute dental issue identified by history or clinician mouth examination
• Receiving denosumab (XGEVA)
• Pregnancy or lactating
• Exception: Patients with secondary or tertiary hyperparathyroidism due to chronic kidney disease and low bone mineral density who are nonsurgical candidates
• Inclusion Criteria (All must be met)
• Diagnosis of osteoporosis or at risk for glucocorticoid-induced osteoporosis
• Prescriber is a VA/VA Community Care endocrinologist, rheumatologist, nephrologist, geriatrician, or locally designated expert
• Patient’s total daily dietary and supplemental calcium intake is 1000 to 1200 mg/day
• 25-hydroxyvitamin D concentration >30 ng/mL or > 20 ng/ml with appropriate intake (e.g., cholecalciferol >800 international units per day)
• Prescriber has documented discussion of severe hypocalcemia risk and need for close monitoring if eGFR < 30ml/min
• For patients with eGFR < 35 ml/min, risks and benefits of indefinite denosumab discussed due to inability to transition to bisphosphonates
• Requirement to transition to another antiresorptive agent upon discontinuation to prevent rebound fractures
• Additional Criteria (One of the following must be met)
• Allergy, contraindication, unsatisfactory response, or intolerable adverse events with bisphosphonate therapy
• Osteoporotic fracture and T-score at hip or spine < -2.5
• Very high fracture probability by Fracture Risk Assessment Tool (FRAX) (e.g., major osteoporosis fracture >30%, hip fracture >4.5%)
• T-score < -3.0
• More than 2 osteoporotic fractures
• Continued bone mineral density loss or sustained osteoporotic fracture while on other approved osteoporosis therapy