From the Guidelines
Fosamax (alendronate) is not indicated for men aged 60 with osteopenia unless they have a high risk of fracture, as the current evidence-based guidelines prioritize treatment for men at high risk of fracture or with a history of fragility fractures. The guidelines recommend oral bisphosphonates, such as alendronate or risedronate, as first-line treatments for men at a high risk of fracture 1. To determine the risk of fracture, tools like FRAX can be used, which takes into account various risk factors including age, sex, and bone mineral density.
When considering treatment with Fosamax, it's essential to ensure that the patient has adequate calcium and vitamin D levels, as these are crucial for bone health 1. The typical dosage of Fosamax is 70 mg once weekly or 10 mg daily, and treatment duration is usually 3-5 years initially, with periodic reassessment. Before starting Fosamax, men should have a dental examination due to the small risk of osteonecrosis of the jaw. Lifestyle modifications, including weight-bearing exercise, smoking cessation, and limiting alcohol consumption, are also important for maintaining bone health.
It's worth noting that the guidelines emphasize the importance of assessing fracture risk using tools like FRAX and considering the patient's overall risk profile before initiating treatment 1. The American College of Physicians guideline also recommends treating osteoporotic men with pharmacologic therapy, but the evidence is weaker for men with osteopenia 1. Therefore, the decision to treat men aged 60 with osteopenia should be based on a comprehensive assessment of their fracture risk and overall health status.
Key points to consider when treating men aged 60 with osteopenia include:
- Assessing fracture risk using tools like FRAX
- Ensuring adequate calcium and vitamin D levels
- Considering lifestyle modifications, such as weight-bearing exercise and smoking cessation
- Monitoring for potential side effects, such as esophageal irritation and osteonecrosis of the jaw
- Periodic reassessment of treatment efficacy and potential adjustment of treatment duration or regimen.
From the FDA Drug Label
1.3 Treatment to Increase Bone Mass in Men with Osteoporosis Alendronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)].
The FDA drug label indicates that Fosamax (Alendronate) is indicated for men with osteoporosis, but it does not specifically mention osteopenia. Therefore, based on the available information, Fosamax (Alendronate) is not indicated for men aged 60 with osteopenia 2.
From the Research
Indications for Fosamax (Alendronate)
- Fosamax (Alendronate) is indicated for the treatment of osteoporosis in men, as shown in studies 3, 4.
- The medication has been found to increase bone mineral density and reduce the risk of fractures in men with osteoporosis 3.
- Alendronate is also effective in treating osteopenia/osteoporosis associated with HIV infection, as demonstrated in a study 5.
Dosage and Administration
- Alendronate can be administered once weekly (70 mg) or once daily (10 mg) 6, 4.
- The once-weekly dosing regimen has been found to be therapeutically equivalent to the daily regimen and is preferred by patients due to its convenience 6, 7.
Efficacy in Men with Osteopenia
- While the provided studies do not specifically address the use of Fosamax in men aged 60 with osteopenia, a study on men with osteoporosis found that alendronate significantly increased bone mineral density and prevented vertebral fractures 3.
- Another study on patients with HIV infection, including those with osteopenia, found that alendronate increased lumbar spine bone mineral density by 5.2% at 48 weeks 5.