From the Guidelines
The recommended length of treatment with Prolia (denosumab) for osteoporosis is typically long-term, with most patients continuing therapy for at least 5 years, as recommended by the American College of Physicians 1. However, it's essential to consider that some patients may require longer treatment durations, and the decision to extend treatment should be based on individual patient factors, such as fracture risk and bone density response to therapy. Prolia is administered as a 60 mg subcutaneous injection every 6 months. It's crucial to understand that discontinuing Prolia without transitioning to another osteoporosis medication can lead to a rebound effect with rapid bone loss and increased fracture risk within 12-18 months after the last dose, as noted in the management of osteoporosis in survivors of adult cancers with nonmetastatic disease 1. This occurs because denosumab works by inhibiting bone resorption, and when stopped, there can be accelerated bone turnover. For patients who need to discontinue Prolia, transition to a bisphosphonate medication is typically recommended to maintain bone density gains, as suggested by the European Calcified Tissue Society 1. Some key points to consider when treating patients with Prolia include:
- Calcium and vitamin D supplementation should be maintained throughout Prolia treatment, with recommended daily intake of 1000-1200 mg of calcium and 800-1000 IU of vitamin D.
- Regular monitoring with bone mineral density testing every 1-2 years is advised to assess treatment effectiveness.
- The treatment decision should be based on a discussion of patient preferences, fracture risk profile, and benefits, harms, and costs of medications, as recommended by the American College of Physicians 1.
From the Research
Length of Treatment with Prolia (Denosumab)
The recommended length of treatment with Prolia (denosumab) for osteoporosis is not strictly defined, as it depends on various factors, including the patient's risk of fracture and response to treatment. However, several studies provide insight into the duration of denosumab treatment:
- Denosumab is administered via subcutaneous injection every 6 months 2, 3, 4, 5.
- The FREEDOM trial and its 7-year open-label extension showed that denosumab reduced the risk of vertebral, nonvertebral, and hip fractures and increased bone mineral density (BMD) over up to 10 years of therapy 4.
- A study found that denosumab was generally well tolerated over up to 10 years of treatment, although an increased risk of multiple vertebral fractures was observed after discontinuation of the drug 4.
- Another study suggested that the longer dosing interval of denosumab (every 6 months) might result in better real-life treatment adherence and persistence compared to weekly or monthly oral bisphosphonate treatment regimens 6.
- 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 6.
Key Considerations
- The optimal strategy for cycling anabolics, anti-resorptives, and off-treatment periods remains to be determined 2.
- Denosumab is a valuable new option for the treatment of postmenopausal osteoporosis in women at increased or high risk of fractures, and may be useful as a first-line treatment in women at increased risk of fractures who are unable to take other osteoporosis treatments 3.
- The potential for multiple vertebral fractures to occur after discontinuation of denosumab requires consideration of subsequent management options 4.