When to prescribe Fosamax (alendronate) for osteoporosis?

From the Guidelines

Fosamax (alendronate) should be prescribed for patients with osteoporosis who have a high risk of fracture, including postmenopausal women and men with a bone mineral density T-score of -2.5 or lower, or those with a history of fragility fracture, as it is a first-line treatment for men at a high risk of fracture 1.

Patient Selection

When considering Fosamax for osteoporosis treatment, the following patient groups are suitable:

• Postmenopausal women and men with a bone mineral density T-score of -2.5 or lower
• Patients with a history of fragility fracture
• Patients with osteopenia (T-score between -1.0 and -2.5) who have additional risk factors such as advanced age, family history of osteoporosis, low body weight, smoking, or long-term corticosteroid use

Dosage and Administration

The standard dosage of Fosamax is 70 mg once weekly or 10 mg daily, taken with a full glass of water at least 30 minutes before the first food or drink of the day. Patients must remain upright for at least 30 minutes after taking the medication to prevent esophageal irritation.

Pre-Treatment Assessment

Before starting Fosamax, patients should have:

• Adequate calcium (1000-1200 mg daily) and vitamin D (800-1000 IU daily) intake
• Dental issues addressed due to the rare risk of osteonecrosis of the jaw
• Kidney function assessed, as Fosamax is not recommended for patients with creatinine clearance below 35 ml/min

Treatment Duration

Treatment duration typically ranges from 3-5 years, after which a drug holiday may be considered based on reassessment of fracture risk, as recommended by the American College of Physicians 1.

Benefits and Harms

Fosamax has been shown to reduce the risk of hip and vertebral fractures in women with osteoporosis, and is associated with a favorable balance of benefits and harms, including a reduction in fracture risk and an increase in bone mass 1. However, it may also be associated with rare but serious adverse events such as osteonecrosis of the jaw and atypical femoral or subtrochanteric fractures 1.

From the FDA Drug Label

Osteoporosis in Postmenopausal Women Osteoporosis is characterized by low bone mass that leads to an increased risk of fracture. The diagnosis can be confirmed by the finding of low bone mass, evidence of fracture on x-ray, a history of osteoporotic fracture, or height loss or kyphosis, indicative of vertebral (spinal) fracture Osteoporosis occurs in both males and females but is most common among women following the menopause, when bone turnover increases and the rate of bone resorption exceeds that of bone formation. Daily oral doses of alendronate (5,20, and 40 mg for six weeks) in postmenopausal women produced biochemical changes indicative of dose-dependent inhibition of bone resorption, including decreases in urinary calcium and urinary markers of bone collagen degradation

Fosamax (alendronate) should be prescribed for osteoporosis when there is evidence of:

• Low bone mass
• History of osteoporotic fracture
• Height loss or kyphosis, indicative of vertebral (spinal) fracture
• Increased risk of fracture due to bone turnover and resorption exceeding bone formation, particularly in postmenopausal women 2 Key points to consider when prescribing Fosamax include:
• Bone resorption inhibition: Alendronate decreases bone resorption without directly inhibiting bone formation
• Dose-dependent effects: Daily oral doses of alendronate produce biochemical changes indicative of dose-dependent inhibition of bone resorption
• Patient population: Osteoporosis is most common among women following menopause, but can occur in both males and females 2

From the Research

Indications for Fosamax (Alendronate) Prescription

Fosamax (alendronate) is prescribed for the treatment of osteoporosis, specifically for postmenopausal women at risk for hip and vertebral fractures 3. The medication is also effective in increasing bone mineral density and reducing the risk of fractures in patients with involutional osteoporosis 4.

Patient Selection

The decision to prescribe Fosamax should be based on the patient's bone mineral density, age, and risk of fractures. Patients with a high risk of fractures, such as those with a history of vertebral or hip fractures, may benefit from Fosamax treatment 3, 4. Additionally, patients with Paget's disease of bone may also be treated with Fosamax, with a once-weekly dosing regimen showing effectiveness in achieving remission 5.

Dosage and Administration

Fosamax can be administered orally, with a recommended dose of 10 mg daily or 70 mg once weekly 6, 7. It is essential to take the medication in the fasting state, with a full glass of water, at least 30 minutes before breakfast, to minimize the risk of esophageal lesions 4.

Efficacy and Safety

Clinical trials have demonstrated the efficacy and safety of Fosamax in increasing bone mineral density and reducing the risk of fractures 3, 4, 7. The medication has been shown to be well-tolerated, with no significant clinical or biological adverse experiences reported in most cases 4, 7. However, proper use and administration of the medication are crucial to minimizing the risk of potential complications, such as esophageal lesions 4.

Key Considerations

• Fosamax is a bisphosphonate, which is currently the pre-eminent therapy for osteoporosis 6.
• The once-weekly dosing regimen of Fosamax offers a convenient and effective treatment option for patients with osteoporosis 6.
• Patients should be instructed on the proper administration of Fosamax to minimize the risk of adverse events 4.