From the Guidelines
Denosumab can be given to patients with vertebral fractures, as it has been shown to reduce the risk of incident radiographic vertebral fractures, incident clinical vertebral fractures, nonvertebral fractures, and hip fractures in women with osteoporosis. The standard dosing for osteoporosis is 60 mg subcutaneously every 6 months (Prolia) 1. Denosumab works by inhibiting RANK ligand, which reduces bone resorption and increases bone density, making it beneficial for fracture healing and prevention of future fractures.
Key Considerations
- Patients should also take calcium (1000-1200 mg daily) and vitamin D (800-1000 IU daily) supplements while on denosumab therapy.
- Discontinuation of denosumab can lead to rapid bone loss and increased fracture risk, so treatment should be continued long-term or followed by another anti-resorptive medication.
- 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 1.
Treatment Duration and Monitoring
- Denosumab is usually prescribed for 3–5 years, and longer in patients who remain at high risk 1.
- Systematic follow-up is advocated, as part of a five-step plan including identifying patients with a recent fracture, inviting them for fracture risk evaluation, differential diagnosis, therapy, and follow-up.
- Risk communication and shared decision making in the care of patients with osteoporosis may have a positive influence on adherence.
From the FDA Drug Label
The primary efficacy variable was the incidence of new morphometric (radiologically-diagnosed) vertebral fractures at 3 years. Women with other diseases (such as rheumatoid arthritis, osteogenesis imperfecta, and Paget's disease) or on therapies that affect bone were excluded from this study. Overall, the mean baseline lumbar spine BMD T-score was -2. 8, and 23% of women had a vertebral fracture at baseline.
Denosumab administration in the presence of a vertebral fracture can be considered, as the study included women with a history of vertebral fracture at baseline.
- The study demonstrated that denosumab significantly reduced the incidence of new morphometric vertebral fractures at 1,2, and 3 years.
- However, it is essential to note that the study excluded women with certain diseases that may affect bone health, and the decision to administer denosumab should be made on a case-by-case basis, considering the individual patient's condition and medical history 2.
From the Research
Denosumab Administration with Vertebral Fracture
- Denosumab can be given to patients with a fracture in the vertebrae, as studies have shown its effectiveness in improving clinical and radiographic outcomes in patients with osteoporotic vertebral compression fractures 3, 4.
- Despite concerns about denosumab's potential to hinder fracture healing, research has found no significant differences between denosumab and teriparatide in terms of clinical outcomes or radiographic measurements 3.
- However, teriparatide has been shown to have a higher incidence of fracture union with paravertebral bone bridge formation compared to denosumab 4.
- It is essential to consider the individual patient's condition and medical history before administering denosumab, as discontinuation of denosumab can be associated with rebound in bone turnover and rebound-associated spontaneous clinical vertebral fractures 5.
Comparison with Other Treatments
- Denosumab, teriparatide, and raloxifene have different mechanisms and benefits for treating osteoporosis, and the choice of treatment should be based on individual patient needs and risk factors 6.
- Vertebral fractures are a significant clinical concern, and patients with these fractures should be considered for antifracture therapy, including denosumab, to prevent future fractures and improve quality of life 7.
Key Considerations
- The decision to administer denosumab to a patient with a vertebral fracture should be made on a case-by-case basis, taking into account the patient's overall health, medical history, and potential risks and benefits of treatment 3, 4, 6.
- Patients with vertebral fractures should receive comprehensive care, including physical and pharmacologic modalities of pain control, exercises or physiotherapy to maintain spinal movement and strength, and consideration for antifracture therapy 7.