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1 Indications And Usage Alendronate Sodium Oral Solution Is A Bisphosphonate Indicated For: • Treatment Of Osteoporosis In Postmenopausal Women ( 1.1 ) • Treatment To Increase Bone Mass In Men With Osteoporosis ( 1.3 ) Limitations Of Use: Optimal Duration Of Use Has Not Been Determined. For Patients At Low-Risk For Fracture, Consider Drug Discontinuation After 3 To 5 Years Of Use. ( 1.6 ) 1.1 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) [See Clinical Studies ( 14.1 ) ] . 1.3 Treatment To Increase Bone Mass In Men With Osteoporosis Alendronate Sodium Is Indicated For Treatment To Increase Bone Mass In Men With Osteoporosis [See Clinical Studies ( 14.3 ) ] . 1.6 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.
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