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1 Indications And Usage Fosamax Plus D Is A Combination Of A Bisphosphonate And Vitamin D Indicated For: Treatment Of Osteoporosis In Postmenopausal Women ( 1.1 ) Treatment To Increase Bone Mass In Men With Osteoporosis ( 1.2 ) Limitations Of Use: Fosamax Plus D Alone Should Not Be Used To Treat Vitamin D Deficiency. ( 1.3 ) 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. ( 1.3 ) 1.1 Treatment Of Osteoporosis In Postmenopausal Women Fosamax ® Plus D Is Indicated For The Treatment Of Osteoporosis In Postmenopausal Women. In Postmenopausal Women, Fosamax Plus D Increases Bone Mass And Reduces The Incidence Of Fractures, Including Those Of The Hip And Spine (Vertebral Compression Fractures). [See Clinical Studies (14.1) .] 1.2 Treatment To Increase Bone Mass In Men With Osteoporosis Fosamax Plus D Is Indicated For Treatment To Increase Bone Mass In Men With Osteoporosis [See Clinical Studies (14.2) ]. 1.3 Important Limitations Of Use Fosamax Plus D Alone Should Not Be Used To Treat Vitamin D Deficiency. The Optimal Duration Of Use Has Not Been Determined. The Safety And Effectiveness Of Fosamax Plus D 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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