From the Guidelines
Prolia (denosumab) is recommended as a treatment option for osteoporosis in postmenopausal women and men with a high fracture risk, with a standard dosage of 60 mg administered as a subcutaneous injection once every six months by a healthcare professional. According to the most recent and highest quality study, denosumab has been shown to be effective in reducing the risk of hip and vertebral fractures in women with known osteoporosis 1. The medication works by inhibiting RANK ligand, a protein that activates bone-removing cells called osteoclasts, thereby decreasing bone breakdown and increasing bone density.
Some key points to consider when prescribing Prolia include:
- Patients should take calcium (1000 mg daily) and vitamin D (at least 400 IU daily) supplements while on Prolia to support bone health 1.
- Common side effects include back pain, arm/leg pain, high cholesterol, and musculoskeletal pain.
- More serious potential side effects include osteonecrosis of the jaw, atypical femur fractures, and increased risk of infections.
- It's essential to maintain regular dental check-ups while on Prolia and inform your dentist about this medication.
- After discontinuation, there can be a rebound effect with rapid bone loss, so transitioning to another osteoporosis medication is typically recommended rather than simply stopping Prolia.
In terms of specific patient populations, denosumab has been shown to be effective in preventing or delaying disease-associated skeletal-related events (SREs) in patients with castration-resistant prostate cancer (CRPC) and bone metastases 1. The medication has also been recommended for use in patients with breast cancer, lung cancer, renal cancer, and other solid tumors with a life expectancy of 3 months and clinically significant bone metastases 1.
Overall, Prolia (denosumab) is a valuable treatment option for patients with osteoporosis and those at risk of skeletal-related events due to cancer. However, it's crucial to carefully consider the potential benefits and risks of the medication and to monitor patients closely for any adverse effects.
From the FDA Drug Label
INDICATIONS AND USAGE Prolia is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture (1.1) to increase bone mass in men with osteoporosis at high risk for fracture (1.2) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture (1.3) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer (1.4) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer (1.5)
Prolia indications include:
- Treatment of postmenopausal women with osteoporosis at high risk for fracture
- Increasing bone mass in men with osteoporosis at high risk for fracture
- Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
- Increasing bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
- Increasing bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer 2 2
From the Research
Overview of Prolia
- Prolia, also known as denosumab, is a human monoclonal antibody used to treat postmenopausal osteoporosis in women at increased or high risk of fractures 3, 4, 5.
- It works by targeting the key bone resorption mediator RANKL, inhibiting osteoclast formation, function, and survival, and reducing bone resorption 3, 4, 5.
Efficacy of Prolia
- Denosumab has been shown to reduce the risk of vertebral, nonvertebral, and hip fractures in postmenopausal women with osteoporosis 3, 4, 5, 6.
- It increases bone mineral density (BMD) at all skeletal sites, including the lumbar spine and total hip, and reduces markers of bone turnover 3, 4, 5, 7.
- Denosumab has been compared to other osteoporosis treatments, such as bisphosphonates, and has been shown to be more effective in improving BMD in some cases 3, 4, 5, 7.
Safety and Tolerability of Prolia
- Denosumab is generally well tolerated, with a safety profile consistent with that observed in clinical trials 3, 4, 5, 6.
- However, there have been reports of an increased risk of multiple vertebral fractures following discontinuation of denosumab 3, 6.
- Other potential safety concerns include infections, cancer, skin reactions, cardiovascular disease, hypocalcemia, osteonecrosis of the jaw, and atypical femur fractures, although further study and experience have provided reassurance on these issues 6.