From the Guidelines
The dose of Prolia (denosumab) is 60 mg every 6 months.
Key Points
- This dose has been shown to reduce the risk of fracture in patients with osteoporosis, particularly in postmenopausal women and men receiving androgen deprivation therapy for nonmetastatic prostate cancer 1.
- The 60 mg every 6 months dose is also recommended for patients with breast cancer receiving aromatase inhibitors, as it has been shown to improve bone density and reduce the risk of fractures 1.
- It is essential to note that denosumab should be administered subcutaneously, and patients should be monitored for hypocalcemia, especially those with impaired renal function 1.
- The use of denosumab has been associated with a decreased incidence of new vertebral fractures, nonvertebral fractures, and hip fractures in patients with osteoporosis 1.
Administration and Monitoring
- Denosumab can be administered to patients with impaired renal function, but the risk of severe hypocalcemia and hypophosphatemia is greater, and serum calcium monitoring is required 1.
- Oral hygiene, baseline dental evaluation, and avoidance of invasive dental surgery during therapy are recommended to reduce the risk of osteonecrosis of the jaw 1.
From the FDA Drug Label
2.3 Recommended Dosage Prolia should be administered by a healthcare professional. The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months.
The dose of Prolia (denosumab) is 60 mg administered as a single subcutaneous injection once every 6 months 2.
From the Research
Dose of Prolia (Denosumab)
- The dose of Prolia (denosumab) is administered subcutaneously every 6 months 3, 4, 5.
- The standard dose of denosumab is 60 mg every 6 months 5, 6.
- Reducing the dose by half (30 mg every 6 months) may be a promising treatment option for maintaining bone mineral density and mineral content while moderately increasing bone turnover markers 6.
Administration and Treatment Regimen
- Denosumab is administered via subcutaneous injection, which may improve adherence to treatment compared to other osteoporosis treatments 3.
- The treatment regimen typically involves administration every 6 months, with some studies suggesting that reducing the dose or extending the treatment interval may be effective in maintaining bone health 6.
Efficacy and Safety
- Denosumab has been shown to reduce the risk of vertebral, nonvertebral, and hip fractures in postmenopausal women with osteoporosis 3, 4, 5.
- The safety profile of denosumab is generally acceptable, with some potential risks and side effects, such as infections, cancer, skin reactions, and cardiovascular disease 4, 7.