JPRN-jRCTs071180086已完成4 期
Effects of monthly injected ibandronate on bone mineral density and microstructure in patients with primary osteoporosis after teriparatide treatment. - MONUMENT study
Osaki Makoto0 个研究点目标入组 66 人开始时间: 2019年3月29日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
研究概览
简要总结
In patients with primary osteoporosis treated with teriparatide, switching to intravenous ibandronate decreased bone resorption markers by 43.9%, increased lumbar bone mineral density by 3.5%, and HR-pQCT tibial cortical bone thickness by 2.6% and decreased BR showing cortical instability by 2.5%. The effectiveness of sequential treatment with ibandronate on bone density and cortical bone microstructure was confirmed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 55age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1.Patients who underwent teriparatide treatment for primary osteoporosis for 12 consecutive months or more (confirmed compliance with over 75% during the period)
- •2.Patients who can receive ibandronate within 8 weeks from the final administration of teriparatide
- •3.Age: Patients over 55 years old
- •4.Gender: female
- •5.Outpatient
- •6.After receiving sufficient explanation for participation in this study, patients who gained written consent by the patient's free will with sufficient understanding
排除标准
- •1.Patients with the following underlying diseases:
- •Serious heart disease, liver disease, renal disorder, diabetes, active malignant tumor
- •Endocrine, metabolic diseases affecting bone metabolism
- •Secondary osteoporosis (steroid, rheumatoid arthritis, immobility)
- •2.Patient with the following medication
- •Steroid: 5 mg or more Use experience of 3 months or more (excluding inhaled steroids)
- •Agents affecting bone metabolism (drugs for malignant tumor etc.)
- •3.Patient falling under any of the contraindication items of drugs used:
- •Patients with a history of hypersensitivity to components of ibandronate formulation or other bisphosphonate drugs
- •Patients with hypocalcemia
- •4.Patients who participated in the clinical trial within 4 months
- •5.Patients who were confirmed to have three or more existing fractures in the first to fourth lumbar vertebrae by X-ray radiophotography during the observation period
- •6.In addition, patients whose research managers judged inappropriate as research subjects
研究者
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