From the Guidelines
Apalutamide has a negative impact on bone health, increasing the risk of fractures and bone mineral density loss in men with prostate cancer, with approximately 12% of patients experiencing fractures compared to about 6% on placebo, as seen in the SPARTAN trial 1. The effects of apalutamide on bone health are a significant concern, particularly in older men or those with pre-existing osteoporosis.
- The SPARTAN trial showed that apalutamide delayed the development of bone metastasis by 2 years compared to placebo, but was associated with a higher rate of pathologic fractures (12% vs 6%) 1.
- A prespecified exploratory analysis of the SPARTAN trial found that health-related quality of life was maintained in both the apalutamide and placebo groups, despite the increased risk of fractures and bone mineral density loss 1.
- The TITAN study also reported a higher incidence of rash and fracture in patients receiving apalutamide compared to those receiving placebo, highlighting the need for careful monitoring and management of adverse events 1.
- To mitigate the negative effects of apalutamide on bone health, patients should undergo baseline bone density testing and regular monitoring, and consider preventive measures such as calcium and vitamin D supplementation, weight-bearing exercise, and possibly bone-targeted agents like denosumab or zoledronic acid for high-risk patients.
- The most recent and highest quality study, the SPARTAN trial 1, provides the strongest evidence for the effects of apalutamide on bone health, and should be considered when making treatment decisions.
From the Research
Effects of Apalutamide on Bone Health
- Apalutamide is a next-generation oral anti-androgen used in the treatment of non-metastatic castration-resistant prostate cancer 2.
- The effects of apalutamide on bone health are a concern, as androgen deprivation therapy (ADT) is known to cause significant loss of bone mineral density (BMD) and increase the risk of fractures 3, 4.
- Studies have shown that patients with non-metastatic castrate-resistant prostate cancer receiving apalutamide can experience decreased BMD, highlighting the need for regular assessment of bone density and management strategies to maintain bone health 5.
Management of Bone Health in Patients Receiving Apalutamide
- Regular assessment of bone density is recommended for patients receiving apalutamide, particularly in those with a history of osteoporosis or fractures 4, 5.
- Nutritional guidance and the use of antiresorptive bone health agents may be necessary to maintain bone health in patients receiving apalutamide 5.
- Lifestyle modifications, such as smoking cessation, moderate alcohol consumption, and regular weight-bearing exercise, can also help to reduce the risk of bone loss and fractures 3, 4.
Clinical Implications
- Clinicians should be aware of the potential effects of apalutamide on bone health and take steps to monitor and manage bone health in patients receiving this treatment 2, 5.
- The use of apalutamide in patients with non-metastatic castration-resistant prostate cancer should be balanced against the potential risks and benefits, including the risk of bone loss and fractures 6.