JPRN-jRCTs051180179已完成未知
Combination therapy of Eldecalcitol with Risedronate on Aromatase Inhibitor treated post-operative Mammary carcinoma In the treatment of bone QUality and quantity Exacerbation (CERAMIQUE) randomized trial in the patients with secondary osteoporosis - CERAMIQUE trial
Imanishi Yasuo0 个研究点目标入组 200 人开始时间: 2019年3月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
Eldecalcitol significantly increased lumbar spine, femoral neck, and total hip BMD in the patients with post-operative mammary carcinoma treating with aromatase inhibitor and risedronate.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 40age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1. Post-operative mammary carcinoma patients whose TNM stage from 0 to IIIA and under receiving aromatase inhibitor.
- •2. Patients who are 40 years or older, with more than 2 years after menopause.
- •3. Patients who received risedronate 17.5 mg/week more than 12 months and can be observed for 2 years.
- •4. Patients with less than -1.0 T score of lumber or total femoral BMD, or with fragile vertebral fractures.
- •5. Patients acquired informed consent about this study.
排除标准
- •1. Contraindication for risedronate use.
- •2. Patients medicated with warfarin.
- •3. Using other osteoporosis drugs such as active vitamin D3, selective estrogen receptor modulators (SERMs), ipriflavone, calcitonin, and bisphosphonate except risedronate.
- •4. Patients suffered from malignancies except mammary carcinoma.
- •5. Patients with serious infection or under serious condition such as malnutrition.
- •6. Patients under insulin therapy.
- •7. Patients with tendency to fall due to paroxysmal disorders.
- •8. Patients who are unable to acquire informed consent due to neuropsychiatric illnesses or brain diseases such as dementia.
- •9. Patients with breast feeding, pregnancy, or possible pregnancy.
- •10. Patients whose corrected serum calcium levels are more than 10.4 mg/dl at the enrollment to this trial.
- •11. Patients whose corrected urinary calcium levels are more than 0.3 Ca (mg)/Cre (mg) at the enrollment to this trial.
- •12. Patients who are advised to remove their teeth at the enrollment to this trial.
- •13. Patients with past histories of osteonecrosis of the jaws.
- •14. Patients judged inappropriate by attending physicians.
研究者
相似试验
已完成
不适用
Combination therapy of Eldecalcitol with Risedronate on Aromatase inhibitor treated post-operative Mammary carcinoma In the prevention of bone QUality and quantity Exacerbation (CERAMIQUE) randomized trialSecondary osteoporosisJPRN-UMIN000008286Osaka City University Graduate School of Medicine200
已完成
4 期
Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With OsteoporosisOsteoporosis, PostmenopausalNCT00035256Eli Lilly and Company330
已完成
不适用
Effects of risedronate and alfacalcidol on parameters of atherosclerosis in type 2 diabetes patients with osteoporosisType 2 diabetes with osteoporosisJPRN-UMIN000001992Department of Internal Medicine 1, Shimane University School of Medicine40
已完成
3 期
Calcium and Vitamin D to Optimize Bone Mass in Boys With Risperidone-induced HyperprolactinemiaRisperidone-induced HyperprolactinemiaNCT00799383Chadi A. Calarge47
Unknown
4 期
The Effect of Zoledronic Acid to Bone Fusion and Bone Metabolism of Patients With Lumbar Degenerative Disease After Lumbar Interbody FusionImage Changes of Lumbar FusionBone Turnover MarkersBone Mineral DensityNCT01310465Fudan University50