Can Fosamax (alendronate) be used to treat osteopenia?

Treatment of Osteopenia with Fosamax (Alendronate)

Fosamax (alendronate) should not be routinely used to treat osteopenia alone, but may be appropriate for osteopenic patients aged 65 or older who are at high risk for fracture based on FRAX score or other risk factors. 1

Evidence-Based Recommendations for Osteopenia

• The American College of Physicians (ACP) recommends that clinicians should make the decision whether to treat osteopenic women 65 years of age or older who are at high risk for fracture based on a discussion of patient preferences, fracture risk profile, and benefits, harms, and costs of medications (Grade: weak recommendation; low-quality evidence) 1

• Treatment should be considered in women with a 10-year risk of major osteoporotic fracture of at least 20% or a risk of hip fracture of at least 3% according to FRAX calculations 1

• Treatment should also be considered in patients who have had a low-trauma fracture, even if DEXA does not indicate osteoporosis 1

• Studies directly addressing the efficacy of pharmacologic treatments for reducing fractures specifically in patients with osteopenia are lacking and more research is needed 1

Alendronate (Fosamax) Information

• Alendronate is FDA-approved for the prevention of osteoporosis at a dose of 5 mg per day or 35 mg per week 1, 2

• For treatment of established osteoporosis, the recommended dose is 10 mg per day or 70 mg per week 1, 2

• Alendronate works by inhibiting bone resorption by interfering with osteoclast activity, which reduces bone turnover and increases bone mineral density 2, 3

• The once-weekly dosing regimen (35 mg for prevention, 70 mg for treatment) is therapeutically equivalent to daily dosing and may improve adherence 4, 3

Efficacy of Alendronate

• Alendronate has demonstrated significant efficacy for secondary prevention (patients with existing fractures or established osteoporosis) with:

  • 45% relative risk reduction for vertebral fractures 5
  • 23% relative risk reduction for nonvertebral fractures 5
  • 53% relative risk reduction for hip fractures 5
  • 50% relative risk reduction for wrist fractures 5

• For primary prevention (patients without previous fractures), alendronate showed:

  • 45% relative risk reduction for vertebral fractures 5
  • No statistically significant reduction in nonvertebral, hip, or wrist fractures 5

Safety Considerations

• Alendronate is generally well tolerated when taken as directed 2, 3

• Common adverse effects include mild upper GI symptoms (abdominal pain, dyspepsia, acid regurgitation) 2, 3

• Rare but serious adverse events include atypical subtrochanteric fractures and osteonecrosis of the jaw 1

• Proper administration is crucial to minimize GI side effects:

  • Take with plain water first thing in the morning
  • Remain upright for at least 30 minutes after taking
  • Do not take with food, beverages, or other medications 2, 4

• Contraindications include:

  • Abnormalities of the esophagus
  • Inability to stand or sit upright for at least 30 minutes
  • Hypocalcemia
  • Hypersensitivity to any component of the product 1, 2

Clinical Decision Algorithm

1. Assess fracture risk in osteopenic patients using:

   • FRAX score calculation 1
   • History of previous fractures 1
   • Age (≥65 years increases risk) 1

2. Consider alendronate for osteopenic patients if:

   • 10-year risk of major osteoporotic fracture ≥20% 1
   • 10-year risk of hip fracture ≥3% 1
   • History of low-trauma fracture 1

3. If treatment is indicated:

   • Use alendronate 35 mg once weekly for prevention 1, 2
   • Ensure adequate calcium and vitamin D intake 1
   • Counsel on lifestyle modifications (weight-bearing exercise, smoking cessation, reducing alcohol intake) 1

4. Monitor:

   • The ACP recommends against bone density monitoring during the 5-year pharmacologic treatment period 1
   • Treatment duration should typically be 5 years 1

Conclusion

While alendronate is FDA-approved for prevention of osteoporosis, the decision to treat osteopenia should be based on overall fracture risk rather than BMD alone. Current guidelines do not support routine treatment of all patients with osteopenia, but rather a targeted approach for those at high risk of fracture.