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APO-ALENDRONATE (alendronate sodium) is indicated for: The treatment and prevention of osteoporosis in postmenopausal women: For the treatment of osteoporosis, APO-ALENDRONATE increases bone mass and prevents fractures, including those of the hip and spine (vertebral compression fractures).
Osteoporosis may be confirmed by the finding of low bone mass (for example, at least 2.0 standard deviations below the premenopausal mean) or by the presence or history of osteoporotic fracture.
For the prevention of osteoporosis, APO-ALENDRONATE may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of future fracture.
Bone loss is particularly rapid in postmenopausal women younger than age 60. Risk factors often associated with the development of postmenopausal osteoporosis include early menopause; moderately low bone mass; thin body build; Caucasian or Asian race; and family history of osteoporosis. The presence of such risk factors may be important when considering the use of APO-ALENDRONATE for prevention of osteoporosis.
The treatment of osteoporosis in men to reduce the incidence of fractures.
The treatment and prevention of glucocorticoid-induced osteoporosis in men and women.
The treatment of Paget's disease of bone in men and women.
Treatment is indicated in patients with Paget's disease of bone having serum 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.
The optimal duration of use of bisphosphates for the treatment of osteoporosis has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.
