Recommended Dose of Denosumab for Osteoporosis
The recommended dose of denosumab (Prolia) for a 67-year-old postmenopausal woman with osteoporosis is 60 mg administered subcutaneously every 6 months. 1
Dosing Protocol
- Administer 60 mg subcutaneously every 6 months in the upper arm, upper thigh, or abdomen 1
- This dosing regimen has been consistently validated across multiple large-scale trials including the pivotal FREEDOM trial, which enrolled women aged 60-90 years with osteoporosis 2, 3
- No dose adjustment is required based on age, body weight (36-140 kg), race, or renal function, including patients on dialysis 1
Required Concurrent Supplementation
- Ensure adequate calcium and vitamin D supplementation during denosumab therapy 4
- Check calcium and vitamin D levels prior to the initial dose to prevent hypocalcemia 4
- All patients in clinical trials received oral calcium (1000-1500 mg/day) and vitamin D (400-1200 IU/day) as supplements 2
Pre-Treatment Requirements
- Perform an oral examination before initiating therapy and ensure good oral hygiene is maintained throughout treatment 2
- Invasive dental procedures (extractions, implant placement) should be avoided during treatment to minimize osteonecrosis of the jaw risk 2
Expected Clinical Outcomes
The 60 mg every 6 months regimen demonstrates robust fracture reduction:
- 68% reduction in vertebral fractures (2.3% vs 7.2% with placebo) 2, 3
- 40% reduction in hip fractures (0.7% vs 1.2% with placebo) 2, 3
- 20% reduction in nonvertebral fractures (6.5% vs 8.0% with placebo) 2, 3
Pharmacokinetic Considerations
- Maximum serum concentration (Cmax) occurs at a median of 10 days post-injection 1
- Mean half-life is 25.4 days 1
- No drug accumulation occurs with the every-6-month dosing schedule 1
- Serum concentrations decline over 4-5 months, making the 6-month interval optimal for sustained bone protection 1
Monitoring Recommendations
- Follow-up DEXA scan in 2 years 4
- Clinical assessment for adverse effects at regular intervals 4
- The American College of Physicians recommends against routine bone density monitoring during the 5-year treatment period 4
Critical Safety Consideration
Do not discontinue denosumab abruptly without transitioning to another antiresorptive agent, as discontinuation leads to rapidly rising bone turnover markers, decreasing bone density, and increased risk of multiple vertebral fractures 5