The purpose of this study was to Investigate the efficacy of Miacalcin (salmon calcitonin) nasal spray in the treatment of steroid-induced osteoporosis. This multicenter study included (two years double-blind phase and one year open-label phase) and involved patients with steroid- induced osteoporosis. Patients were eligible if they had osteoporosis and had received steroid therapy for RA or pulmonary disease. Subjects were randomized to one of four treatment groups: 100 IU, 200 IU or 400 IU of Miacalcin. Nasal Spray or placebo once a day. In the open-label phase, all patients received 400 IU Miacalcin. Nasal Spray each day. Duke investigators enrolled six patients into the original double-blind study, 5 with rheumatoid arthritis and 1 with pulmonary disease. One patient withdrew consent secondary to worsening of his chronic lung disease. All patients completed the two year double-blind study. Four patients entered the open-label study. Of these four, three completed all required visits and one is lost to follow-up. Therefore, we are not expecting to see study patients during the upcoming year. There have been no unexpected serious adverse events to report. All participants tolerated the study medication well. There are no preliminary results of the study to report. Significance: Exogenous corticosteroids represents a major cause of osteoporosis in patients with rheumatic diseases and other chronic inflammatory conditions. Corticosteroid therapy in such conditions often must be administered for long periods of time, leading to significant morbidity and mortality from fractures of the spine and hip. There are no approved therapies for corticosteroid-related osteoporosis. Corticosteroids decrease absorption of calcium from the gut, increase urinary excretion of calcium, and directly inhibit bone formation. In such circumstances, bone resorption may be increased by secondary hyperparathyroidism and by the direct effects of corticosteroids. It seems likely that anti-resorptive agents such as the bisphosphonates and calcitonin will be effective in treating bone loss from corticosteroid therapy. Thus, the results of this study may provide a way to treat corticosteroid-induced osteoporosis. If effective, nasal calcitonin may reduce bone loss and potentially decrease the occurrence of spine and hip fractures in patients who must receive long-term corticosteroid therapy. Future plans: The data from this study are currently being analyzed and prepared for publication. No further studies are planned at this time.
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