From the Guidelines
Prolia (denosumab) should be administered at a dose of 60 mg every 6 months for the treatment of osteoporosis. This dosing regimen has been shown to reduce the risk of fracture, as demonstrated in clinical trials 1. The medication is typically given as a subcutaneous injection, usually in the upper arm, upper thigh, or abdomen.
Key Considerations
- Before starting Prolia, patients should have their calcium and vitamin D levels checked, as hypocalcemia is a potential side effect 1.
- Supplementation with calcium (1000-1200 mg daily) and vitamin D (800-1000 IU daily) is generally recommended while on Prolia therapy.
- Patients should also have regular dental check-ups as osteonecrosis of the jaw is a rare but serious potential complication.
- Kidney function should be monitored as severe renal impairment increases the risk of hypocalcemia.
Administration and Storage
- The injection should be stored in a refrigerator until use but can be kept at room temperature for up to 14 days if needed.
- It is essential to follow the recommended dosing schedule to minimize the risk of adverse effects and ensure optimal treatment outcomes, as supported by the study published in the Journal of Clinical Oncology 1.
From the FDA Drug Label
The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months. The Prolia dose is 60 mg administered subcutaneously every 6 months.
- The dose should be administered by a healthcare professional.
- Patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily.
- If a dose is missed, it should be administered as soon as possible, and then scheduled every 6 months from the date of the last injection 2.
From the Research
Prolia Dose Information
- The dose of Prolia (denosumab) is administered via subcutaneous injection once every 6 months 3, 4.
- This dosing interval may result in better real-life treatment adherence and persistence compared to weekly or monthly oral bisphosphonate treatment regimens 5.
Administration and Efficacy
- Denosumab has been shown to reduce the risk of vertebral, nonvertebral, and hip fractures in postmenopausal women with osteoporosis 3, 4.
- It has also been found to increase bone mineral density (BMD) at all skeletal sites, with greater increases in BMD compared to bisphosphonates 6, 7.
- The efficacy of denosumab in reducing fracture risk and increasing BMD has been demonstrated in several clinical trials, including the FREEDOM trial and its 7-year open-label extension 3.
Comparison to Bisphosphonates
- Denosumab has been compared to bisphosphonates in several studies, with results showing that denosumab increases BMD more than bisphosphonates at 12 and 24 months 7.
- However, the difference in fracture risk reduction between denosumab and bisphosphonates is still uncertain, with only one study demonstrating a greater reduction in osteoporotic fracture incidence with denosumab treatment 7.