What's the next step for a patient with osteoporosis who has been taking Fosamax (alendronate) for a few years?

Next Steps After Several Years of Alendronate (Fosamax) for Osteoporosis

After several years of alendronate therapy for osteoporosis, the patient should be considered for a bisphosphonate holiday rather than indefinite continuation, with reassessment of fracture risk to guide the decision.

Assessment of Treatment Duration and Fracture Risk

The decision to continue or pause alendronate therapy should be based on:

• Treatment duration: Current evidence suggests that increasing bisphosphonate therapy beyond 3-5 years reduces risk for vertebral fractures but not other fractures, while increasing risk for long-term adverse effects 1.

• Fracture risk assessment: Using FRAX or other validated tools to determine if the patient remains at high risk despite previous treatment.

• Response to therapy: Evaluate BMD changes and any fractures that occurred during treatment.

Algorithm for Decision Making

1. If patient has completed 5 years of alendronate therapy:

   • Consider a bisphosphonate holiday 1, 2
   • Duration of holiday should be individualized based on fracture risk factors

2. If patient has severe osteoporosis (T-score ≤ -3.5 or history of fragility fractures):

   • Consider continuing therapy beyond 5 years 2
   • Reassess annually for adverse effects

3. If patient has moderate risk (T-score between -2.5 and -3.0 without fractures):

   • Bisphosphonate holiday for 2-3 years is appropriate 2
   • Monitor BMD during holiday period

4. If patient has responded well to therapy with significant BMD improvement:

   • Drug holiday is appropriate with monitoring 1

Monitoring During Bisphosphonate Holiday

• Bone mineral density testing every 2 years 2
• Assessment of bone turnover markers if available
• Clinical evaluation for new fractures
• Resume therapy if:
  • Significant BMD decline (>5%)
  • New fracture occurs
  • High-risk status returns

Alternative Treatment Options

If continuing osteoporosis therapy is indicated but alendronate is no longer appropriate:

1. Switch to denosumab: Consider for patients with contraindications to bisphosphonates 1, 2

   • 60 mg subcutaneously every 6 months
   • Note: Requires transition to another antiresorptive if discontinued to prevent rebound bone loss

2. Consider anabolic therapy: For patients at very high fracture risk 2

   • Teriparatide (20 mcg subcutaneously daily)
   • Must be followed by antiresorptive therapy after completion

3. Zoledronic acid: Consider annual IV administration (5 mg) if GI issues with oral bisphosphonates 1, 2

Important Considerations and Cautions

• Calcium and vitamin D supplementation: Should be continued regardless of decision about alendronate 1

  • Calcium: 1200 mg daily
  • Vitamin D: 800-1000 IU daily

• Rare but serious adverse effects of long-term bisphosphonate use:

  • Osteonecrosis of the jaw
  • Atypical femoral fractures
  • Risk increases with treatment duration beyond 5 years 1, 2

• Alendronate's persistence in bone: The drug remains in bone matrix for years after discontinuation, providing residual anti-fracture benefit during a drug holiday 3, 4

• Lifestyle modifications: Continue to emphasize weight-bearing exercise, smoking cessation, limiting alcohol consumption, and fall prevention strategies 1, 2

Summary

For patients who have taken alendronate for several years, a bisphosphonate holiday is generally recommended after 5 years of therapy unless the patient remains at very high fracture risk. The decision should be based on current fracture risk, treatment response, and potential for adverse effects from continued therapy. Ongoing calcium and vitamin D supplementation remains essential regardless of the decision about alendronate continuation.