What is the recommended use and dosage of Alendronate for osteoporosis treatment?

From the Guidelines

Alendronate is recommended at a dose of 70mg once weekly or 10mg daily for the treatment of osteoporosis in men and women, with the goal of reducing the risk of hip and vertebral fractures. The medication should be taken first thing in the morning with a full glass of plain water (6-8 oz), at least 30 minutes before consuming any food, beverages, or other medications 1. Patients must remain upright (sitting or standing) for at least 30 minutes after taking alendronate to prevent esophageal irritation. Some key points to consider when prescribing alendronate include:

• Treatment duration is generally long-term, often 3-5 years initially, with possible reassessment after this period 1
• Calcium (1000-1200mg daily) and vitamin D (800-1000 IU daily) supplements are usually recommended alongside alendronate therapy 1
• Alendronate works by inhibiting bone resorption by osteoclasts, thereby increasing bone mineral density and reducing fracture risk 1
• Common side effects include gastrointestinal issues, musculoskeletal pain, and headache 1
• Rare but serious side effects can include osteonecrosis of the jaw and atypical femur fractures, particularly with long-term use 1
• Patients with severe kidney disease (creatinine clearance <35 mL/min), hypocalcemia, or esophageal abnormalities should avoid alendronate 1 High-quality evidence supports the use of alendronate for the treatment of osteoporosis, with studies showing a reduction in vertebral, nonvertebral, and hip fractures compared with placebo in postmenopausal osteoporotic women 1.

From the FDA Drug Label

1.1 Treatment of Osteoporosis in Postmenopausal Women Alendronate sodium tablets, USP are indicated for the treatment of osteoporosis in postmenopausal women.

The recommended dosage is:

• 70 mg once weekly
• 10 mg daily

Key Points:

• Alendronate sodium is indicated for the treatment of osteoporosis in postmenopausal women.
• The recommended dosage is 70 mg once weekly or 10 mg daily.
• The optimal duration of use has not been determined, but the safety and effectiveness of alendronate sodium for the treatment of osteoporosis are based on clinical data of four years duration 2.

From the Research

Recommended Use and Dosage of Alendronate

The recommended use and dosage of Alendronate for osteoporosis treatment are as follows:

• Alendronate is a nitrogen-containing bisphosphonate that binds to bone surfaces and inhibits bone resorption by osteoclasts 3.
• The optimum dosage of Alendronate is 10 mg/day orally administered, which produces sustained increases in bone mineral density (BMD) in postmenopausal women with or without osteoporosis, in men with primary osteoporosis, and in both men and women with or without osteoporosis receiving systemic corticosteroid therapy 3, 4.
• Alendronate 70 mg administered once weekly and 35 mg twice weekly are as effective at increasing BMD as 10 mg/day in postmenopausal women with osteoporosis 3.
• Alendronate is effective and generally well tolerated in the treatment of women or men with primary (including postmenopausal) or corticosteroid-induced osteoporosis and in the prevention of osteoporosis in postmenopausal women 3, 5.

Efficacy of Alendronate

The efficacy of Alendronate in preventing fractures is as follows:

• Alendronate reduces the risk of radiographic vertebral fracture, clinical vertebral fracture, or hip fracture by 47 to 56% in postmenopausal women who had ≥1 existing vertebral fracture and in those with no existing vertebral fractures but who had osteoporosis 3.
• Alendronate probably results in a clinically important reduction in clinical vertebral fractures, and may lead to a clinically important reduction in non-vertebral fractures, hip fractures, and wrist fractures in postmenopausal women with osteoporosis 6.
• Alendronate may lead to a clinically important reduction in clinical vertebral and non-vertebral fractures, but it might make little or no difference to hip and wrist fractures, withdrawals due to adverse events, and serious adverse events in postmenopausal women without osteoporosis 6.

Safety of Alendronate

The safety of Alendronate is as follows:

• Alendronate is generally well tolerated when taken as recommended, with adverse events tends to be transient and associated with the upper GI tract, most commonly including abdominal pain, nausea, dyspepsia, acid regurgitation, and musculoskeletal pain 3, 4.
• The updated evidence for the safety risks of Alendronate suggests that, irrespective of participants' risk of fracture, Alendronate may lead to little or no difference for gastrointestinal adverse events 6.
• Zero incidents of osteonecrosis of the jaw and atypical femoral fracture were observed in postmenopausal women treated with Alendronate 6.