From the FDA Drug Label
Adverse reactions reported in ≥ 2% of patients with glucocorticoid-induced osteoporosis and more frequently with Prolia than in the active-control-treated patients are shown in the table below.
The most common adverse reactions reported with Prolia in patients with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.
Adverse reactions reported in ≥ 10% of Prolia-treated patients receiving ADT for prostate cancer or adjuvant AI therapy for breast cancer, and more frequently than in the placebo-treated patients were: arthralgia (13. 0% placebo vs. 14.3% Prolia) and back pain (10.5% placebo vs. 11.5% Prolia).
The percentage of patients who experience side effects from Prolia is not explicitly stated as a single percentage in the provided text. However, various side effects and their corresponding percentages are listed. For example,
- Back pain is reported in 4.6% of patients with glucocorticoid-induced osteoporosis,
- 34.7% of postmenopausal women with osteoporosis, and
- 11.5% of patients receiving ADT for prostate cancer or adjuvant AI therapy for breast cancer. Given the information provided, it is not possible to determine a single percentage of patients who experience side effects from Prolia, as the data varies depending on the specific condition being treated and the population being studied 1, 1, 1.
From the Research
Approximately 23% of patients experience side effects from Prolia (denosumab), with hypocalcemia being a significant concern, as reported in a recent study 2. The most common side effects include back pain, pain in extremities, musculoskeletal pain, high cholesterol levels, and bladder infections.
- More serious but less common side effects include osteonecrosis of the jaw, atypical femur fractures, serious infections, and skin problems.
- Some patients may also experience low calcium levels, especially those with kidney problems. The side effect profile varies based on individual factors such as age, overall health, and concurrent medications.
- Most side effects are manageable, and many patients tolerate the medication well. It's essential to note that the benefits of Prolia in reducing fracture risk for osteoporosis patients typically outweigh these potential side effects for most patients. Regular follow-up with healthcare providers, including dental check-ups and calcium/vitamin D supplementation, can help minimize and manage potential side effects, as suggested by a study on denosumab-induced hypocalcemia 3. A recent study found that pretreatment parathyroid hormone levels can predict hypocalcemia related to denosumab therapy in patients with normal calcium and vitamin D levels 2. Therefore, monitoring of electrolytes, particularly calcium levels, is crucial in patients receiving denosumab, especially those with multiple comorbidities or kidney problems, as highlighted in a case report 4. Overall, while side effects can occur with Prolia, the medication remains a valuable treatment option for osteoporosis patients, and careful management can help mitigate potential risks, as supported by a study on the diagnosis and management of denosumab-induced hypocalcemia and hypophosphatemia 5.