What is alendronate used for?

Indications and Usage, quoted from the label by Rising Pharma Holdings, Inc. (ANDA090124). Cross-references to other label sections are left out.

Treatment of Osteoporosis in Postmenopausal Women

Alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).

Prevention of Osteoporosis in Postmenopausal Women

Alendronate sodium tablets are indicated for the prevention of postmenopausal osteoporosis.

Treatment to Increase Bone Mass in Men with Osteoporosis

Alendronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis.

Treatment of Glucocorticoid-Induced Osteoporosis

Alendronate sodium tablets are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density.

Treatment of Paget's Disease of Bone

Alendronate sodium tablets are indicated for the treatment of Paget’s disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.

Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of alendronate sodium tablets for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

Source: DailyMed label, set id ffdd2496-d253-419b-85a6-8c615f7545f1, version 7, effective June 12, 2026. NDC 64980-340, one of 32 listings for this product.

Indications and Usage, quoted from the label by Hikma Pharmaceuticals USA Inc. (ANDA090520). Cross-references to other label sections are left out.

Treatment of Osteoporosis in Postmenopausal Women

Alendronate sodium is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).

Treatment to Increase Bone Mass in Men with Osteoporosis

Alendronate sodium is indicated for treatment to increase bone mass in men with osteoporosis.

Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of alendronate for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

Source: DailyMed label, set id c910bb05-279b-4ffa-a867-46f4a0853ed5, version 4, effective January 15, 2026. NDC 0054-0282, one of 2 listings for this product.