From the FDA Drug Label
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 ≥ 2% of postmenopausal women with osteoporosis and more frequently in the Prolia-treated women than in the placebo-treated women are shown in the table below. Hypercholesterolemia 280 (7.2) 236 (6.1)
Hypercholesterolemia is listed as one of the most common adverse reactions reported with Prolia in patients with postmenopausal osteoporosis, with a higher incidence in the Prolia-treated group (7.2%) compared to the placebo-treated group (6.1%) 1.
From the Research
Prolia (denosumab) has not been shown to cause high cholesterol as a direct side effect, and its use should not be discontinued solely due to concerns about cholesterol levels. Clinical studies and post-marketing surveillance of Prolia, which is primarily used to treat osteoporosis and prevent bone fractures, have not established a causal relationship between this medication and elevated cholesterol levels 2. The most common side effects of Prolia include back pain, pain in extremities, musculoskeletal pain, high cholesterol, and urinary tract infections. While high cholesterol is listed among these side effects, it's essential to understand that this doesn't necessarily mean Prolia causes cholesterol elevation - it may simply reflect the natural occurrence of high cholesterol in the population that typically uses this medication (primarily older adults) 3, 4.
Some key points to consider when evaluating the relationship between Prolia and cholesterol levels include:
- The mechanism of action of denosumab, which involves reducing osteoclastogenesis, does not directly suggest an impact on cholesterol metabolism 5, 6.
- Clinical trials have focused on the efficacy and safety of denosumab in preventing fractures and improving bone mineral density, with less emphasis on its potential effects on lipid profiles 3, 2.
- The population typically using Prolia, such as older adults, may have a higher baseline risk of hypercholesterolemia due to age, diet, and other factors, which could confound the interpretation of side effect data 4, 6.
If you're taking Prolia and are concerned about cholesterol levels, regular lipid panel monitoring is advisable. However, other factors like diet, exercise, genetics, and concurrent medications typically have much stronger influences on cholesterol levels than Prolia 2. Therefore, management of cholesterol levels should focus on these modifiable risk factors rather than discontinuation of Prolia, which is effective in reducing the risk of fractures in patients with osteoporosis 3, 2.