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II-A. Osteoporosis Treatment in patients unable to tolerate routine therapy

 

Statement:  The North Carolina Rheumatology Association recommends that intravenous bisphoshonate therapy, when prescribed by rheumatologists after thorough evaluation, be available, utilized and appropriately reimbursed by health insurers for the treatment of osteopenia, osteoporosis, and/or low-trauma fractures (fragility fractures), in appropriate patients who cannot tolerate or are refractory to treatment with estrogen replacement therapy, raloxifene (Evista), alendronate (Fosamax), risedronate (Actonel), or oral ibandronate (Boniva). Use of parenteral bisphoshonates is also not inappropriate in these same patients after successful treatment with teraperitide in specific cases. We believe that this represents the standard of care for these seriously ill patients.

Discussion:  The NIH Consensus Statement on Osteoporosis Prevention, Diagnosis, and Therapy defines osteoporosis as "a skeletal disorder characterized by compromised bone strength predisposing to an increased risk of fracture. Bone strength reflects the integration of two main features: bone density and bone quality." Osteoporosis is a silent disease until bones become so weak that fractures occur. Osteoporosis is a major health problem in the United States, affecting approximately 10 million people. Approximately 18 million people have osteopenia. One of every three women over the age of 50 has osteoporosis and nearly half of all women over 50 will break a bone in her lifetime due to osteoporosis. Approximately one in every eight men over the age of 50 will have an osteoporotic fracture in his lifetime. Ultimately, in an extremely elderly population, one in every six men will have a hip fracture.

Appropriate therapeutic alternatives for the prevention and treatment of osteoporosis include calcium, vitamin D, estrogen replacement therapy, raloxifene (Evista), alendronate (Fosamax), risedronate (Actonel), calcitonin (Miacalcin), oral and parenteral ibandronate (Boniva), and teraperitide (Forteo). Unfortunately, some patients have contraindications to taking these medications, develop intolerable side effects, or are refractory to therapy. An alternative to these routine medications is intravenous bis-phosphonate therapy, such as pamidronate (Aredia) or ibandronate (Boniva). Pamidronate has been shown to inhibit bone resorption and improve bone density in patients with osteoporosis. Ibandronate is FDA approved for IV administration for treatment of osteoporosis.

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