Osteoporosis Treatment

Introduction to Romosozumab Therapy

Romosozumab should be followed by an antiresorptive agent after the 12-month treatment course is completed to maintain fracture risk reduction benefits, as recommended by clinical guidelines 1, 2

The recommended dosing of romosozumab is 210mg monthly via subcutaneous injection, requiring two 105mg/1.17ml prefilled syringes, with treatment limited to 12 months only, as the anabolic effect wanes after this period 1, 2
Patients should receive calcium supplementation as recommended during romosozumab treatment 2

After completing 12 months of romosozumab, patients must transition to an antiresorptive agent (bisphosphonate or denosumab) to maintain fracture risk reduction benefits, with failure to provide sequential therapy potentially resulting in bone loss 1, 2

Initial fracture risk assessment should be performed within 6 months of starting treatment, with reassessment using FRAX and BMD testing every 1-3 years for adults ≥40 years, and clinical fracture risk reassessment every 12 months in all patients continuing treatment 3

One year of romosozumab followed by denosumab may maintain fracture risk reduction for up to 36 months, although exact data is not provided 1, 2
Romosozumab provides significant BMD gains at 12 months (spine: 13%, hip: 7%), based on research similar to that cited in 1 and 2
The American College of Rheumatology conditionally recommends against using romosozumab due to risk of myocardial infarction, stroke, or death, with a black box warning regarding cardiovascular risk 2
Romosozumab is considered medically necessary for postmenopausal osteoporosis in patients with a history of fragility fractures, or a pre-treatment T-score ≤-2.5 or osteopenia with high FRAX probability, as outlined in Aetna's Clinical Policy Bulletin (CPB) #0954, with specific criteria including indicators of very high fracture risk, failure of prior injectable osteoporosis therapy, or oral bisphosphonate trial of at least 1-year duration or clinical reason to avoid it 1
Romosozumab treatment carries a risk of myocardial infarction, stroke, or death, which should be carefully considered, with treatment limited to 12 monthly doses due to waning anabolic effect 1