What is the use of Alendronate (bisphosphonate)?

From the Guidelines

Alendronate is a bisphosphonate medication that should be used as first-line treatment for primary osteoporosis in both females and males to reduce the risk of hip and vertebral fractures. The standard dose is 70mg taken once weekly or 10mg daily, and it should be taken first thing in the morning with a full glass of plain water (6-8 ounces), 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.

Key Points to Consider

• The typical treatment duration is 3-5 years, though some patients may benefit from longer therapy based on their fracture risk 1.
• Alendronate works by inhibiting osteoclasts, the cells responsible for bone resorption, thereby slowing bone loss and increasing bone density 1.
• Common side effects include gastrointestinal issues like heartburn, abdominal pain, and nausea 1.
• Rare but serious side effects include osteonecrosis of the jaw and atypical femur fractures, particularly with long-term use 1.
• Adequate calcium (1000-1200mg daily) and vitamin D (800-1000 IU daily) supplementation should accompany alendronate therapy for optimal effectiveness 1.

Evidence-Based Recommendations

• High-quality evidence showed that bisphosphonates, including alendronate, reduce vertebral, nonvertebral, and hip fractures compared with placebo in postmenopausal osteoporotic women 1.
• The evidence base strongly supports the use of bisphosphonates or denosumab in the treatment of osteoporosis in men, and suggests that oral bisphosphonates should be recommended as first-line therapy with intravenous bisphosphonates as second-line therapy 1.
• Adherence is a substantial issue when considering any therapy but particularly so with oral bisphosphonates, and can be monitored by measurement of bone turnover markers at baseline and at 3 months 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. 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 Long-term treatment of osteoporosis with alendronate sodium 10 mg/day (for up to five years) reduced urinary excretion of markers of bone resorption, deoxypyridinoline and cross-linked N-telopeptides of type I collagen, by approximately 50% and 70%, respectively, to reach levels similar to those seen in healthy premenopausal women

The use of Alendronate (bisphosphonate) is for the treatment and prevention of osteoporosis in postmenopausal women, by reducing bone resorption and increasing bone mass 2.

From the Research

Use of Alendronate

• Alendronate is a nitrogen-containing bisphosphonate that binds to bone surfaces and inhibits bone resorption by osteoclasts 3.
• It is used to treat osteoporosis in postmenopausal women, men with primary osteoporosis, and both men and women with corticosteroid-induced osteoporosis 3, 4.
• Alendronate has been shown to increase bone mineral density (BMD) and reduce the risk of fractures, including vertebral and hip fractures 3, 5, 4.

Efficacy of Alendronate

• Studies have demonstrated that alendronate is effective in reducing the risk of clinical vertebral fractures by 47-56% in postmenopausal women with existing vertebral fractures 3.
• Alendronate has also been shown to be more effective than other treatments, such as intranasal calcitonin and conjugated estrogens, in increasing BMD and reducing the risk of fractures 3, 6.
• A Cochrane review found that alendronate probably results in a clinically important reduction in clinical vertebral fractures and may lead to a reduction in non-vertebral fractures, hip fractures, and wrist fractures 5.

Safety and Tolerability of Alendronate

• Alendronate is generally well tolerated when taken as recommended, with common adverse events including abdominal pain, nausea, dyspepsia, and musculoskeletal pain 3, 4.
• However, there have been reports of oesophageal ulceration and other gastrointestinal adverse events, which are thought to be related to noncompliance with the manufacturer's recommendations for administration of the drug 3, 4.
• The evidence suggests that alendronate may lead to little or no difference in gastrointestinal adverse events compared to placebo 5.

Treatment Options After Alendronate

• For patients who do not respond adequately to alendronate, transitioning to other therapies, such as zoledronic acid, strontium ranelate, denosumab, or teriparatide, may be considered 7.
• Studies have shown that transitioning from alendronate to these therapies can maintain or further increase BMD, although more research is needed to determine the long-term effects of these transitions 7.