What is the dosing frequency and duration of treatment with Prolia (denosumab)?

From the Guidelines

Prolia (denosumab) should be administered every 6 months as a 60 mg subcutaneous injection for the treatment of osteoporosis, with a long-term duration of treatment, often continuing for many years or indefinitely, to minimize the risk of rebound bone loss and increased fracture risk. The strongest evidence of benefit from antiresorptive drugs is for treatment with denosumab at the osteoporosis dose of 60 mg every 6 months, as demonstrated in the FREEDOM trial (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months) 1. This dosing frequency has been shown to reduce the risk of fracture, including new radiographic vertebral fractures, nonvertebral fractures, and hip fractures.

When considering the discontinuation of Prolia, it is essential to transition to an alternative osteoporosis medication to prevent the rebound effect with accelerated bone loss and increased fracture risk within 12-18 months after the last dose. Patients receiving Prolia should also take calcium (1000-1200 mg daily) and vitamin D (800-1000 IU daily) supplements to support bone health and ensure the medication works effectively. Before starting treatment, patients should have dental examinations as there is a small risk of osteonecrosis of the jaw, and hypocalcemia should be corrected prior to administration.

Key points to consider when treating patients with Prolia include:

• Dosing frequency: every 6 months
• Duration of treatment: long-term, often continuing for many years or indefinitely
• Calcium and vitamin D supplementation: essential to support bone health
• Dental examinations: necessary before starting treatment to assess the risk of osteonecrosis of the jaw
• Transition to alternative medication: crucial when discontinuing Prolia to prevent rebound bone loss and increased fracture risk, as recommended by the European Calcified Tissue Society 2.

From the FDA Drug Label

The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months. Administer Prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen If a dose of Prolia is missed, administer the injection as soon as the patient is available. Thereafter, schedule injections every 6 months from the date of the last injection.

The dosing frequency of Prolia (denosumab) is every 6 months. The duration of treatment is not explicitly stated in the provided text, but it can be inferred that treatment should continue as long as the patient is at risk for fracture and is benefiting from the treatment, with regular monitoring and evaluation by a healthcare professional 3, 4, 5. Key points to consider:

• The dose of Prolia is 60 mg administered subcutaneously.
• Injections should be given every 6 months.
• Patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily.
• Missed doses should be administered as soon as possible, with subsequent injections scheduled every 6 months from the date of the last injection.

From the Research

Dosing Frequency and Duration of Treatment with Prolia (Denosumab)

• The dosing frequency of Prolia (denosumab) is once every 6 months via subcutaneous injection 6, 7, 8, 9, 10.
• The duration of treatment with Prolia (denosumab) can vary, but studies have shown its effectiveness in increasing bone mineral density (BMD) and reducing the risk of fractures over a period of 12 months or more 6.
• In one study, patients were treated with denosumab for up to 4 years, with 48, 29, 11, and 10 patients treated for 12, 24, 36, and 48 months, respectively 6.
• Another study found that denosumab treatment was effective in increasing BMD and reducing markers of bone turnover over a period of up to 8 years 10.

Administration and Adherence

• The subcutaneous injection of denosumab every 6 months may improve adherence to treatment compared to other osteoporosis treatments 7, 8, 9.
• Positive feedback to patients based on measured BMD increases and good safety profile can have a significant, positive impact on patients' real-life adherence to denosumab treatment 9.