What treatment is recommended for patients with a high Fracture Risk Assessment Tool (FRAX) score?

Treatment Recommendations for Patients with High FRAX Scores

Pharmacologic treatment should be initiated in patients with a high FRAX score, defined as a 10-year risk of major osteoporotic fracture of at least 20% or a risk of hip fracture of at least 3%. 1

Risk Assessment and Classification

FRAX is a validated tool that calculates 10-year probability of major osteoporotic fracture and hip fracture by combining risk factors with or without femoral neck BMD. Risk stratification helps guide treatment decisions:

• High risk: FRAX 10-year risk of major osteoporotic fracture ≥20% or hip fracture ≥3%
• Very high risk: Prior osteoporotic fracture(s), BMD T-score ≤-3.5, FRAX 10-year risk of major osteoporotic fracture ≥30% or hip fracture ≥4.5%, or high glucocorticoid use (≥30 mg/day for >30 days or cumulative doses ≥5 g/year) 1
• Moderate risk: FRAX 10-year risk of major osteoporotic fracture 10-19% or hip fracture 1-3% 1
• Low risk: FRAX 10-year risk of major osteoporotic fracture <10% or hip fracture ≤1% 1

For patients on glucocorticoids >7.5 mg/day, FRAX scores should be adjusted by multiplying major osteoporotic fracture risk by 1.15 and hip fracture risk by 1.2 1.

Treatment Algorithm for High FRAX Score Patients

First-Line Therapy

• Bisphosphonates are strongly recommended as first-line therapy for patients with high fracture risk 2
  • Oral options: alendronate, risedronate
  • IV option: zoledronate (second choice)

For Very High-Risk Patients

• Anabolic agents (teriparatide) may be preferred as initial therapy for very high-risk patients 1
  • Particularly beneficial in glucocorticoid-induced osteoporosis, increasing lumbar spine BMD by 7.2% 2
  • Must be followed by antiresorptive therapy when completed 1

Alternative Options

• Denosumab is recommended as a fourth-choice option 2
• Raloxifene is conditionally recommended against due to risk of venous thromboembolism and fatal stroke 1, 2
• Romosozumab should not be used in patients with history of myocardial infarction or stroke within the preceding year due to cardiovascular risks 3

Lifestyle Modifications (Required for All Patients)

• Calcium and vitamin D supplementation:

  • Ages 51-70: 1,200 mg calcium, 600 IU vitamin D daily
  • Ages 71+: 1,200 mg calcium, 800 IU vitamin D daily 1
  • Serum vitamin D level of 20 ng/mL (50 nmol/L) is recommended for bone health

• Exercise: Weight-bearing and resistance exercises to improve bone density and reduce fall risk 2

• Fall prevention strategies: Home safety assessment, balance training, medication review 2

• Lifestyle modifications: Smoking cessation, limiting alcohol consumption to ≤2 drinks/day 2

Monitoring Treatment Response

• DXA testing every 2 years during treatment to monitor response 2
• Reassessment of treatment after 5 years of bisphosphonate therapy 2
• If using anabolic agents like teriparatide, follow with antiresorptive therapy to maintain gains 1

Important Clinical Considerations

1. Most patients with high FRAX scores have T-scores in the osteoporotic range at one or more BMD measurement sites (83-85%), making treatment decisions straightforward 4

2. FRAX can still be used to predict fracture probability in women currently or previously treated for osteoporosis, though it should not be used to assess treatment-related fracture risk reduction 5

3. The absolute benefit of treatment (e.g., with alendronate) is greatest among patients with the highest FRAX scores 6

4. When calculating FRAX, including T-scores is essential for optimal application, as FRAX scores without T-scores may lead to inappropriate treatment recommendations 7

5. Sequential therapy is necessary after discontinuation of certain medications:

   • After denosumab: Start bisphosphonate 6-7 months after discontinuation to prevent rapid bone loss
   • After teriparatide: Start antiresorptive therapy to maintain gains 1

By following these evidence-based recommendations, clinicians can effectively reduce fracture risk and improve outcomes in patients with high FRAX scores.