DOUBLE-BLIND STUDY OF 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的双盲研究

• 批准号: 5215580
• 负责人: Eugene William St. Clair
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5215580
• 关键词: calcitonin; clinical research; dosage forms; drug adverse effect; drug screening /evaluation; hormone analog; hormone regulation /control mechanism; hormone therapy; human subject; human therapy evaluation; inhalation drug administration; osteoporosis; steroids

The objectives of this study are to determine the efficacy and safety of three dose levels of Miacalcin Nasal Spray in comparison to placebo in the treatment of bone loss at axial and appendicular skeletal sites in patients with steroid-induced osteoporosis. The primary efficacy variable will be bone mineral density of the lumbar spine. This is a three year study ( two years double-blind and one year open-label) with steroid-induced osteoporosis associated with treatment of an underlying pulmonary disease or rheumatoid arthritis. Patients were randomized to one of four treatment groups and received 100 IU, 200 IU, or 400 IU of nasal calcitonin or nasal placebo once a day. In the open-label phase, all patients received 400 IU Miacalcin Nasal Spray each day. Six patients entered the original double-blind study. Five with rheumatoid arthritis and one with pulmonary disease. One patient withdrew consent secondary to worsening of his chronic lung disease. All other participants have completed the two year double-blind study and, except for one, all participated in the open-label study. The study is now closed; results are pending.

本研究的目的是确定以下药物的有效性和安全性： 密钙星鼻喷雾剂与安慰剂相比的三个剂量水平 治疗中轴和四肢骨骼部位的骨质流失 类固醇引起的骨质疏松症患者。 主要功效 变量将是腰椎的骨矿物质密度。 这是一个 三年研究（两年双盲和一年开放标签） 类固醇诱发的骨质疏松症与潜在的治疗相关 肺部疾病或类风湿性关节炎。 患者被随机分配至 四个治疗组之一接受 100 IU、200 IU 或 400 IU 鼻用降钙素或鼻用安慰剂每天一次。 在开放标签阶段， 所有患者每天接受 400 IU 密钙星鼻喷雾剂。 六名患者进入了最初的双盲研究。 五同 类风湿性关节炎和一种患有肺部疾病的患者。 一名患者 由于慢性肺病恶化，他撤回了同意书。 全部 其他参与者已经完成了为期两年的双盲研究，并且， 除一名外，所有人都参加了开放标签研究。 该研究是 现已关闭；结果正在等待中。