Should Fosamax (alendronate) be prescribed to patient women with osteopenia or only to those with osteoporosis?

Treatment of Women with Osteopenia: Fosamax (Alendronate) Recommendations

For women with osteopenia, treatment with Fosamax (alendronate) should be reserved for those 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. 1

Recommendations for Women with Osteopenia

Who Should Receive Alendronate Treatment

• Treatment decisions for women with osteopenia should be individualized based on fracture risk assessment 1
• Women aged 65 or older with severe osteopenia (T-score < -2.0) are more likely to benefit from treatment than those with mild osteopenia (T-score between -1.0 and -1.5) 1
• Higher risk factors that may warrant treatment include: lower body weight, smoking, weight loss, family history of fractures, decreased physical activity, alcohol or caffeine use, low calcium and vitamin D intake, and corticosteroid use 1
• Treatment should be considered for women with osteopenia near the osteoporosis threshold (T-score close to -2.5) 1

Evidence for Treatment in Osteopenia

• Low-quality evidence shows that bisphosphonate treatment in women with osteopenia near the osteoporosis threshold may reduce fracture risk 1
• A post hoc analysis of 4 large RCTs showed that risedronate significantly reduced the risk for fragility fracture compared with placebo (73% lower than placebo) in women with advanced osteopenia 1
• The American College of Physicians believes that the benefit of fracture reduction is likely to be similar across all bisphosphonates, based on data in osteoporotic women 1
• Low-certainty evidence from a long-term (6 years) RCT showed that zoledronate may reduce clinical or vertebral fractures in older females with low bone mass 1

Treatment Approach

• Generic alendronate should be prescribed if possible rather than more expensive brand-name medications 1
• The standard dose is 70 mg once weekly, which is therapeutically equivalent to daily dosing 2, 3
• Adequate calcium (1200 mg daily from all sources) and vitamin D (800-1000 IU daily) intake should be part of fracture prevention 1
• Duration of treatment should be limited to 5 years due to increased risk of long-term harms with prolonged use 1

Benefits and Risks of Alendronate Treatment

Benefits

• Alendronate produces sustained increases in bone mineral density (BMD) in postmenopausal women with or without osteoporosis 3
• For primary prevention (including osteopenia), alendronate may reduce clinical vertebral fractures (RR 0.45,95% CI 0.25 to 0.84) and non-vertebral fractures (RR 0.83,95% CI 0.72 to 0.97) 4
• Low-dose alendronate (70 mg every two weeks) has been shown to be as effective as standard-dose (70 mg weekly) for increasing BMD in Chinese women with osteopenia or osteoporosis 5

Risks and Side Effects

• Common adverse effects include transient upper GI tract symptoms (abdominal pain, nausea, dyspepsia, acid regurgitation) and musculoskeletal pain 3
• Rare but serious adverse effects with prolonged use include atypical subtrochanteric fractures and osteonecrosis of the jaw 1
• Oral bisphosphonates should be avoided in patients with esophageal emptying disorders and those who cannot sit upright due to risk of pill esophagitis 1
• The risk for severe adverse effects increases with prolonged use of bisphosphonates 1

Clinical Considerations and Monitoring

Administration

• Alendronate should be taken on an empty stomach in the morning, 30 minutes before food or other medications, with a full glass of water 1, 3
• Patient should remain upright for at least 30 minutes after taking the medication to reduce risk of esophageal irritation 3
• Calcium supplements should be taken at a different time than bisphosphonates as calcium binds and inactivates bisphosphonates 1

Monitoring

• The ACP recommends against bone density monitoring during the 5-year pharmacologic treatment period for osteoporosis in women 1
• Consider stopping bisphosphonate treatment after 5 years unless the patient has a strong indication for treatment continuation 1
• The decision for a temporary bisphosphonate treatment discontinuation (holiday) should be based on baseline risk for fractures 1

Conclusion

When treating women with osteopenia, alendronate should be prescribed selectively to those at higher risk of fracture, particularly women 65 years or older with severe osteopenia (T-score < -2.0) or with multiple risk factors for fracture. For women with osteoporosis, alendronate is clearly indicated as a first-line treatment. The balance of benefits and harms favors treatment in higher-risk individuals, while those with mild osteopenia and fewer risk factors are less likely to benefit.