Should an elderly female patient with osteoporosis in the right and left femoral neck and stable to mildly progressing osteopenia in the lumbar spine, who has been taking Fosamax (alendronate) for 3 years, continue Fosamax or switch to a different medication?

Should This Patient Continue Fosamax or Switch Medications?

This patient should continue Fosamax (alendronate) for the full 5-year standard treatment duration, as she has only completed 3 years and shows stable to mildly progressing disease without treatment failure. 1

Rationale for Continuing Current Therapy

The American College of Physicians strongly recommends 5 years as the standard treatment duration for bisphosphonate therapy in osteoporotic women. 1 Your patient has completed only 3 years, placing her in the middle of the evidence-based treatment window where maximal fracture reduction benefits occur without significant increases in serious adverse events. 1

Evidence Supporting Continuation Through Year 5

• Fracture reduction efficacy is maintained throughout the full 5-year period, with alendronate demonstrating a 48% reduction in vertebral fractures and significant reductions in hip fractures in landmark trials. 2

• BMD increases progressively during the first 5 years of treatment, with continued gains observed through year 5 (lumbar spine increased by 0.94% and trochanter by 0.88% between years 3-5 in extension studies). 2

• The risk-benefit ratio remains favorable through year 5, as high-certainty evidence demonstrates fracture reduction benefits without significant increases in serious adverse events during this timeframe. 1

Why "Stable to Mildly Progressing" Does NOT Constitute Treatment Failure

The American College of Physicians explicitly recommends against routine BMD monitoring during the initial 5-year treatment period, because fracture reduction occurs even without BMD increases. 1 This is a critical point: your patient's stable BMD at the femoral neck (the highest-risk fracture site) represents therapeutic success, not failure.

Treatment failure requiring medication change would be defined by:

• New fractures occurring during treatment 3
• Continued bone loss or significant BMD decline (≥10% per year) 1
• Multiple vertebral fractures despite therapy 1

Your patient exhibits none of these features. Mild progression in the lumbar spine (which already shows less severe disease—osteopenia rather than osteoporosis) does not meet the threshold for treatment failure. 3

When to Consider Switching After 5 Years

After completing the full 5-year course, reassess fracture risk using these high-risk features that would warrant continuation or switching: 1

Continue alendronate beyond 5 years or switch to denosumab if:

• Previous hip or vertebral fractures occurred 1
• Multiple non-spine fractures 1
• Hip BMD T-score ≤ -2.5 despite treatment 1
• Age >80 years 1
• Ongoing glucocorticoid use (≥7.5 mg prednisone daily) 1

Consider a drug holiday after 5 years if:

• No fractures during treatment 1
• Hip BMD T-score > -2.5 after treatment 1
• No high-risk features listed above 1

Critical Safety Considerations During Years 3-5

Ensure Proper Administration

• Take alendronate with a full glass of water (6-8 ounces), remain upright for at least 30 minutes, and avoid food/drink during this period to minimize esophageal risk. 1

Complete Dental Work Now

• Ensure dental work is completed before continuing therapy, as osteonecrosis of the jaw risk increases with cumulative exposure, particularly beyond 5 years total treatment. 1

Maintain Adequate Supplementation

• Ensure adequate calcium (1000-1200 mg/day) and vitamin D (800 IU/day) intake throughout treatment to maintain efficacy and reduce fracture risk. 1, 4

Common Pitfalls to Avoid

Do not switch medications prematurely based on stable BMD alone. The FLEX trial demonstrated that women who discontinued alendronate after 5 years had only a modest increase in clinical vertebral fractures (5.3% vs 2.4%) but no difference in non-vertebral or hip fractures, confirming that the critical treatment window is the full 5 years. 1

Do not switch to denosumab without a compelling indication. While denosumab shows greater BMD increases than bisphosphonates (3.5% vs 2.6% for alendronate at the hip), this does not translate to superior fracture outcomes in patients already treated with bisphosphonates. 1 More importantly, denosumab discontinuation causes rebound vertebral fractures and requires immediate transition to bisphosphonates within 6 months—a significant management burden. 1

Do not perform routine BMD monitoring during the treatment period. Fracture reduction occurs even without BMD increases, and monitoring may lead to inappropriate treatment changes. 1