MIACALCIN NASAL SPRAY IN STEROID INDUCED OSTEOPOROSIS

米钙星鼻喷雾剂治疗类固醇引起的骨质疏松症

• 批准号: 6243941
• 负责人: Eugene William St. Clair
• 金额: $ 3.24万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1975
• 资助国家: 美国
• 起止时间: 1975-10-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6243941
• 关键词: calcitonin; clinical research; drug adverse effect; hormone therapy; human subject; human therapy evaluation; inhalation drug administration; osteoporosis; respiratory disorder; rheumatoid arthritis; steroids

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.

本研究的目的是研究密钙星的功效 （鲑鱼降钙素）鼻喷雾剂治疗类固醇引起的 骨质疏松症。 这项多中心研究包括（两年双盲 阶段和一年开放标签阶段）并涉及使用类固醇的患者 诱发骨质疏松。 如果患者患有骨质疏松症，则符合资格 并接受过类固醇治疗以治疗 RA 或肺部疾病。 科目 被随机分配到四个治疗组之一：100 IU、200 IU 或 400 密钙星的 IU。 鼻喷雾剂或安慰剂每天一次。 在开放标签中 阶段，所有患者均接受 400 IU 密钙星。每天喷鼻剂。 杜克大学的研究人员将六名患者纳入最初的双盲试验 研究显示，5 名患有类风湿性关节炎，1 名患有肺部疾病。 一 患者因慢性肺部恶化而撤回同意 疾病。 所有患者都完成了为期两年的双盲研究。 四 患者进入开放标签研究。 这四项中，三项已完成 所有必需的访视，其中一次因后续行动而丢失。 因此，我们不是 预计在来年见到研究患者。 有 没有意外的严重不良事件需要报告。 所有参与者 对研究药物的耐受性良好。 尚无初步结果 要报告的研究。 意义：外源性皮质类固醇是导致 风湿病和其他慢性病患者的骨质疏松症 炎症状况。 在这种情况下进行皮质类固醇治疗 通常必须长期施用，导致 脊柱和髋部骨折的发病率和死亡率很高。 目前尚无批准的皮质类固醇相关疗法 骨质疏松症。 皮质类固醇会减少肠道对钙的吸收，增加 尿中钙的排泄，并直接抑制骨的形成。 在 这种情况下，继发性骨吸收可能会增加 甲状旁腺功能亢进症和皮质类固醇的直接作用。 它 似乎可能是抗再吸收剂，例如双膦酸盐和 降钙素可有效治疗皮质类固醇引起的骨质流失 治疗。 因此，这项研究的结果可能提供一种治疗方法 皮质类固醇引起的骨质疏松症。如果有效，鼻用降钙素可能 减少骨质流失，并可能减少脊柱和骨质疏松症的发生 必须长期接受皮质类固醇治疗的髋部骨折患者 治疗。 未来计划：目前正在分析本研究的数据并 准备出版。 目前没有进一步的研究计划。