From the Guidelines
Prolia (denosumab) treatment for osteoporosis is typically recommended for patients with a FRAX score indicating a 10-year probability of ≥20% for a major osteoporotic fracture (MOF) or ≥3% for hip fracture, as supported by the 2022 American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis 1. The FRAX score criteria for Prolia treatment in osteoporosis are based on the patient's 10-year probability of experiencing a major osteoporotic fracture (MOF) or hip fracture.
- The treatment is recommended for patients with a high fracture risk, defined as a FRAX score indicating a 10-year probability of ≥20% for MOF or ≥3% for hip fracture.
- The FRAX score is used in conjunction with bone mineral density (BMD) measurements to assess the patient's fracture risk.
- Prolia is administered as a 60 mg subcutaneous injection every 6 months and is particularly beneficial for postmenopausal women and men at high fracture risk.
- Patients should also take calcium (1000-1200 mg daily) and vitamin D (800-1000 IU daily) supplements while on Prolia therapy, as recommended by the guideline 1.
- Before starting treatment, baseline dental health should be assessed due to the rare risk of osteonecrosis of the jaw, and kidney function should be monitored as severe renal impairment increases hypocalcemia risk, as noted in the guideline 1. The mechanism of action of Prolia differs from bisphosphonates, making it an important alternative for patients who cannot tolerate or have failed other osteoporosis treatments, as supported by the guideline 1.
- Prolia works by inhibiting RANK ligand, which reduces osteoclast formation and activity, thereby decreasing bone resorption and increasing bone density.
- The guideline recommends shared decision-making for the choice of oral or intravenous bisphosphonates, denosumab, or parathyroid hormone analogs, and conditional recommendation of anabolic agents as initial therapy for those with high and very high fracture risk 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
FRAX Score Criteria for Prolia Treatment
The FRAX score is a tool used to assess the 10-year probability of major osteoporotic fractures. The criteria for Prolia (denosumab) treatment in osteoporosis patients are based on the FRAX score, among other factors.
- The median 10-year probability of major osteoporotic fractures using the FRAX algorithm was 14.9% in patients not previously receiving antiosteoporotic therapy before the prescription of denosumab 2.
- Denosumab reduced the risk of clinical osteoporotic fractures in postmenopausal women, particularly in those with moderate to high fracture risk as assessed with FRAX 3.
- The reduction in fracture risk was greater in those at moderate to high risk, with a 50% reduction at a 30% probability of fracture (90th percentile of the study population) 3.
Treatment Efficacy and Safety
The efficacy and safety of denosumab in osteoporosis treatment have been evaluated in several studies.
- Denosumab has been shown to improve bone mineral density and reduce the incidence of new fractures in postmenopausal women and men 4, 5.
- The treatment was associated with a 32% decrease in clinical osteoporotic fractures over 3 years, with greater efficacy in those at moderate to high risk of fracture 3.
- Denosumab was well-tolerated, with a low frequency of adverse reactions and no increase in the risk of cancer, infection, cardiovascular disease, delayed fracture healing, or hypocalcemia 4, 5.
Patient Selection
Denosumab may be an appropriate initial therapy in patients at high risk for fracture, including older patients who have difficulty with the dosing requirements of oral bisphosphonates, as well as patients who are intolerant of, unresponsive to, or have contraindications to other therapies 5.