Alendronate sodium tablets for osteoporosis and Paget's disease treatment

Alendronate sodium tablets are oral bisphosphonate medications approved for treating and preventing osteoporosis in postmenopausal women and men, managing glucocorticoid-induced osteoporosis, and treating Paget's disease of bone. They work by increasing bone mass and reducing fracture risk, with safety and efficacy established for up to four years of use.

• Treatment of osteoporosis in postmenopausal women: Increases bone mass and reduces fractures including hip and spine fractures.
• Prevention of osteoporosis in postmenopausal women.
• Treatment to increase bone mass in men with osteoporosis.
• Treatment of glucocorticoid-induced osteoporosis in men and women receiving daily prednisone-equivalent doses of 7.5 mg or greater with low bone mineral density.
• Treatment of Paget’s disease of bone in patients with elevated alkaline phosphatase (at least twice normal), symptoms, or risk of complications.

Alendronate Sodium

Alendronate sodium belongs to the bisphosphonate class, which slows bone breakdown by inhibiting osteoclasts, the cells that dissolve bone. This leads to an increase in bone mineral density and helps reduce the risk of fractures.

Treatment of osteoporosis in postmenopausal women and men:

• 10 mg tablet once daily or 70 mg tablet once weekly.

Prevention of osteoporosis in postmenopausal women:

• 5 mg tablet once daily or 35 mg tablet once weekly.

Treatment of glucocorticoid-induced osteoporosis:

• 5 mg once daily for most patients; 10 mg once daily for postmenopausal women not receiving estrogen.

Treatment of Paget's disease of bone:

• 40 mg once daily for six months.
• Re-treatment may be considered after 6 months if needed, based on serum alkaline phosphatase levels.

Administration instructions:

• Take tablet whole with 6 to 8 ounces of plain water at least 30 minutes before the first food, drink, or medication of the day.
• Do not lie down for at least 30 minutes after taking and until after the first food of the day.
• If a weekly dose is missed, take it the morning after remembering; do not take two doses the same day.
• Supplement calcium and vitamin D if dietary intake is insufficient.

• Abnormalities of the esophagus that delay emptying (e.g., stricture, achalasia).
• Inability to sit or stand upright for at least 30 minutes after taking the tablet.
• Hypocalcemia not corrected before starting treatment.
• Known hypersensitivity to alendronate or any tablet component.

Upper gastrointestinal adverse reactions:

Alendronate can irritate the esophagus and stomach lining, sometimes causing esophagitis, ulcers, or bleeding. Avoid lying down or taking without a full glass of water, and stop treatment if symptoms like difficulty or pain swallowing, or new/worsening heartburn occur.

Hypocalcemia:

Low blood calcium levels must be corrected before starting treatment and monitored during therapy.

Severe musculoskeletal pain:

Severe bone, joint, or muscle pain can occur; discontinue alendronate if symptoms develop.

Osteonecrosis of the jaw (ONJ):

Rare cases have been reported, especially with invasive dental procedures or other risk factors. Dental examination before treatment and caution with dental surgery are advised.

Atypical femur fractures:

Unusual low-trauma fractures of the thigh bone have been reported. Patients with thigh or groin pain should be evaluated for incomplete fractures.

Renal impairment:

Not recommended for patients with creatinine clearance under 35 mL/min.

Common side effects:

• Upper gastrointestinal discomfort, including esophageal irritation and ulcers.

Serious side effects:

• Severe bone, joint, and muscle pain.
• Osteonecrosis of the jaw.
• Atypical femur fractures.
• Hypersensitivity reactions such as urticaria and angioedema.

Taking alendronate with beverages other than plain water, food, or some medications reduces its absorption. Patients should take alendronate at least 30 minutes before any other oral intake except plain water.