This protocol addresses patients with osteoporotic pathological fracture who meet one or more criteria placing them at very high fracture risk — a distinct clinical subset in which the treatment approach differs substantially from standard-risk management.

Very High-Risk Criteria

Multiple vertebral fractures
Bone mineral density T-score ≤ −3.0 to −3.5
Recent fragility fracture within the previous 1–2 years
High-dose glucocorticoids >7.5 mg/day of prednisolone equivalent for over 3 months
FRAX 10-year major osteoporotic fracture probability ≥ 30%
FRAX 10-year hip fracture probability ≥ 4.5%

Treatment Approach

For patients meeting these criteria, current evidence and clinical guidelines consistently support an osteoanabolic-first approach — an initial phase using a bone-forming agent, followed by a consolidation phase. Adjunct nutritional and exercise components are also specified.

Full sequencing, agent selection, durations, and monitoring strategy are detailed in the complete protocol below.

Clinical Targets

References

DOI: 10.1136/bmj‐2024-081250

Features include multiple vertebral fractures, T-score ≤−3.0 to −3.5, a recent fragility fracture within the previous one to two years, high dose glucocorticoids >7.5 mg/day of prednisolone or equivalent over three months, or FRAX for MOF >30% or hip fracture >4.5%.
For patients at very high risk, teriparatide, abaloparatide, or romosozumab is recommended first line in all guidelines.
The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) guideline supports an osteoanabolic-first approach for patients at very high risk of fracture.
In people at higher risk, such as older people with history of previous fracture, a higher target of −2.0 to −1.5 might be advisable, as supported by evidence from the FREEDOM and ARCH trials, as well as robust meta-regression data showing continued reduction in fracture risk up to a T-score of −1.5 at the total hip.
On teriparatide or abaloparatide, aim for P1NP above reference range or change greater than LSC.
On anti-resorptives, aim for suppression of P1NP and CTX below mean/median of healthy adult or change greater than LSC.
The National Academy of Medicine recommends a target 25-hydroxyvitamin D concentration of 20 ng/mL, whereas other guidelines suggest 30 ng/mL for older adults and at-risk populations.

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Treatment of Osteoporosis with Pathological Fracture: Multiple Vertebral Fractures or Very Low Bone Mineral Density

Very High-Risk Criteria

Treatment Approach

Clinical Targets

References