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Uses

Osteoporosis

Alendronate is used for prevention of osteoporosis in postmenopausal women with risk factors for development of osteoporosis. Risk factors include premature ovarian failure; family history of osteoporosis; small, slim body frame; endocrine disorders (e.g., thyrotoxicosis, hyperparathyroidism, Cushing’s syndrome, hyperprolactinemia, insulin-dependent diabetes mellitus); cigarette smoking; excessive alcohol use; sedentary lifestyle; low body weight; moderately low body mass; low dietary calcium intake; or Caucasian or Asian race.

Alendronate is used alone or in fixed combination with cholecalciferol (vitamin D₃) for treatment of osteoporosis in postmenopausal women.

Alendronate is used alone or in fixed combination with cholecalciferol for treatment of osteoporosis in men.

Alendronate/cholecalciferol fixed combination is not recommended for treatment of vitamin D deficiency.

Alendronate has been used concomitantly with hormone replacement therapy.

Corticosteroid-induced Osteoporosis

Alendronate is used for treatment of corticosteroid-induced osteoporosis in patients receiving corticosteroids (daily dosage ≥5–7.5 mg of prednisone).

Alendronate is used for prevention of corticosteroid-induced osteoporosis† in patients receiving corticosteroid therapy (daily dosage ≥5 mg of prednisone).

American College of Rheumatology considers patients receiving ≥5 mg prednisone daily for ≥3 months at risk for bone loss. Recommends bisphosphonate therapy for all long-term corticosteroid-treated men, premenopausal women (with caution), and postmenopausal women with or without hormone replacement therapy (combined estrogen and progestin therapy).

Paget’s Disease of Bone

Alendronate is used for treatment of moderate to severe Paget’s disease of bone (osteitis deformans) in patients with serum alkaline phosphatase concentrations ≥ twice ULN or who are symptomatic or at risk for future complications.

Dosage and Administration

General

• Use adjunctively with other measures (e.g., diet, weight-bearing exercise, physical therapy, reduction in smoking, alcohol use) to retard further bone loss.
• Supplemental calcium and vitamin D recommended if daily dietary intake is inadequate, particularly in patients with Paget’s disease of bone or receiving corticosteroids.
• Supplemental vitamin D recommended in patients at increased risk for vitamin D insufficiency (e.g., >70 years of age, nursing home bound, chronically ill, with GI malabsorption syndrome) if necessary. (See Metabolic Effects under Cautions.)
• Recommended intake of vitamin D is 400–800 units daily; once-weekly dose of alendronate/cholecalciferol fixed-combination preparation containing cholecalciferol 2800 or 5600 units provides the equivalent of 400 or 800 units, respectively, of vitamin D daily.

Administration

Oral Administration (Alendronate and Alendronate/Cholecalciferol)

Administer tablet orally upon arising with a full glass (180–240 mL) of plain water at least 30 minutes before first food, beverage, or other orally administered drug of the day. (See Food under Pharmacokinetics.)

Drink at least 60 mL (2 oz., a quarter of a cup) of water after taking the oral solution to facilitate gastric emptying.

Administer in an upright position (sitting or standing). Avoid lying down for at least 30 minutes following administration and until after the first food of the day. (See GI Effects under Cautions.)

Avoid administering at bedtime or before arising for the day.

Do not suck or chew tablets; potential oropharyngeal irritation.

Avoid any other medications, including calcium supplements or antacids, for 30 minutes after alendronate is administered. (See Antacids or Mineral Supplements Containing Divalent Cations under Interactions.)

If a weekly dose is missed, administer missed dose the morning after it is remembered, followed by resumption of the regular weekly schedule. However, do not take two 70-mg tablets on the same day.

Dosage

Available as alendronate sodium; dosage expressed in terms of alendronate.

Adults

Osteoporosis

Prevention of Postmenopausal Osteoporosis

Oral

Alendronate 5 mg once daily or 35 mg once weekly.

Treatment of Osteoporosis

Oral

Alendronate 10 mg once daily or 70 mg once weekly in men and postmenopausal women.

Alendronate/cholecalciferol fixed-combination: Usually, alendronate 70 mg and cholecalciferol 5600 units once weekly in men and postmenopausal women. Alternatively, alendronate 70 mg and cholecalciferol 2800 units once weekly.

Corticosteroid-induced Osteoporosis

Prevention of Corticosteroid-induced Osteoporosis

Oral

Alendronate 5 mg once daily in postmenopausal women receiving hormone replacement therapy (HRT), premenopausal women, and men.†

Alendronate 10 mg once daily in postmenopausal women not receiving HRT.†

Continue alendronate as long as patient continues to receive corticosteroid therapy.†

Treatment of Corticosteroid-induced Osteoporosis

Oral

Alendronate 5 mg once daily in postmenopausal women receiving HRT, premenopausal women, and men.

Alendronate 10 mg once daily in postmenopausal women not receiving HRT.

Continue alendronate as long as patient continues to receive corticosteroid therapy.

Paget’s Disease of Bone

Oral

Alendronate 40 mg once daily for 6 months.

Consider retreatment after a 6-month posttreatment evaluation period if relapse occurs (i.e., increased serum alkaline phosphatase concentration) or if initial treatment failed to normalize serum alkaline phosphatase concentrations.

Special Populations

Dosage in Renal Impairment

No dosage adjustment required in patients with mild to moderate impairment (Cl_cr 35–60 mL/minute); not recommended in patients with severe impairment (Cl_cr <35 mL/minute).

Geriatric Patients

No dosage adjustment required.