From the Guidelines
A very high estimated fracture risk is considered to be a prior osteoporotic (OP) fracture(s) or a bone mineral density (BMD) t-score ≤−3.5 or a FRAX (GC-Adjusted) 10-year risk of major osteoporotic fracture (MOF) ≥30% or hip ≥4.5% or high glucocorticoid (GC) ≥30 mg/day for >30 days or cumulative doses ≥5 g/year, as defined by the 2022 American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis 1.
This definition is based on the latest guidelines and takes into account various risk factors, including prior fractures, BMD, and glucocorticoid use. The FRAX tool is a widely used and validated assessment tool that incorporates these risk factors to estimate the 10-year probability of major osteoporotic fracture and hip fracture.
Key factors that contribute to a very high fracture risk include:
- Prior osteoporotic fracture(s)
- Low BMD (t-score ≤−3.5)
- High 10-year risk of MOF (≥30%) or hip fracture (≥4.5%) as calculated by FRAX
- High-dose glucocorticoid use (≥30 mg/day for >30 days) or cumulative doses (≥5 g/year)
Patients with a very high fracture risk require immediate pharmacologic intervention with bone-strengthening medications, such as bisphosphonates, denosumab, teriparatide, or abaloparatide, as well as lifestyle modifications, including adequate calcium and vitamin D intake, weight-bearing exercise, and fall prevention strategies 1.
It is essential to note that the risk of fracture is highest for patients treated with very high or large cumulative glucocorticoid doses, and the use of FRAX GC correction is recommended for prednisone-equivalent doses >7.5 mg/day 1.
In clinical practice, the assessment of fracture risk should be individualized, taking into account the patient's specific risk factors, comorbidities, and preferences. The choice of therapy should be based on the patient's risk category, with anabolic agents being preferred for those at very high risk of fracture 1.
Overall, the management of patients with a very high fracture risk requires a comprehensive approach, including pharmacologic intervention, lifestyle modifications, and regular monitoring to prevent fractures and minimize their consequences.
From the FDA Drug Label
Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy
- A very high estimated fracture risk is not explicitly defined in the provided drug label.
- However, high risk for fracture is defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy 2.
- It can be inferred that a very high estimated fracture risk would likely include patients with a history of multiple osteoporotic fractures, several risk factors for fracture, or those who have failed or are intolerant to multiple available osteoporosis therapies.
- However, without explicit definition, no conclusion can be drawn about the specific criteria for a very high estimated fracture risk.
From the Research
Definition of Very High Estimated Fracture Risk
A very high estimated fracture risk is typically defined as a 10-year probability of major osteoporotic fracture exceeding 20% or a 10-year probability of hip fracture exceeding 3% [ 3, 4 ].
Factors Associated with High Fracture Risk
Several factors are associated with a high fracture risk, including:
- Prior fracture [ 5 ]
- Low bone mineral density (BMD) [ 3, 6,4 ]
- Rheumatoid arthritis [ 6, 7 ]
- Glucocorticoid use 4
- Smoking 4
- Alcohol intake 4
Prevalence of High Fracture Risk
The prevalence of high fracture risk varies by age, sex, and race, with older adults, women, and non-Hispanic white persons having higher probabilities of fracture 4.
Assessment of Fracture Risk
The Fracture Risk Assessment Tool (FRAX) is a widely used tool to assess fracture risk, providing individualized 10-year probabilities of hip and major osteoporotic fracture [ 5, 3, 6,4,7 ].