JPRN-UMIN000023855Completed未知
A multicenter prospective study on the efficacy and safety of denosumab in gastrointestinal cancer patients receiving short-term periodic steroid premedication of chemotherapy-induced nausea and vomiting (ESPRESSO-02/HGCSG1602) - Evaluation of the steroid premedication for cancer chemotherapy associated osteoporosis (ESPRESSO-02/HGCSG1602)
HGCSG (Hokkaido Gastrointestinal Cancer Study Group)0 sites45 target enrollmentStarted: December 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 45
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 40years-old to 90years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •(1) Current regular use of steroids. (2) Current regular use of bisphosphonates or other drugs that affect the skeleton. (3) Regimens with steroid free interval >4-weeks. (4) Patients who cannot do the examination for DXA (5) Past radiation therapy for the evaluation lesion of DXA (6) Past total or partial gastrectomy (7) Serum calcium levels < 8.0 mg/dL (8) On going dental interventional treatment. (9) Renal dysfunction (serum creatinine levels: over 1.5 mg/dL) (10) Other concurrent active cancer (synchronous double cancer or heterochronous double cancer with a disease-free interval of 5 years or shorter,excluding colorectal cancer, lesions consistent with intraepithelial cancer, i.e., carcinoma in situ, or intramucosal cancer that are assessed as cured by local treatment). (11) Premenopausal, pregnant, breast-feeding, possibly pregnant women or patients wishing to have children. (12) Accumulation of pleural, ascitic, or pericardial fluid requiring drainage (13) Active bleeding (14) No prior operation for gastrointestinal tract within 28 day except proctostomy. (15) Current or past severe lung disease (e.g. interstitial pneumonia, pulmonary fibrosis, or severe emphysema). (16) Any other active illness such as severe cardiac disease (e.g. myocardial infarction, angina pectoris, arrhythmia, or cardiac failure). Any of the following events within the 6 months prior to enrollment. (17) Serious hypersensitivity to any ingredients of denosumab. (18) Active infection and/or inflammatory diseases. (19) Severe cardiac failure (over NYHA II) (20) Ineligible for participating in this study according to the investigator.
Investigators
Similar Trials
Completed
Not Applicable
Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapyacute cholecystitisJPRN-UMIN000022987Department of Gastroenterology Kitasato University School of Medicine50
Recruiting
Not Applicable
A Multicenter Prospective Study on the Efficacy of Small Intestinal Capsule Endoscopy in Hemodialysis PatientsChronic kidney diseaseJPRN-UMIN000041904Keio university school of medicine500
Recruiting
Not Applicable
A multicenter prospective study of the efficacy of prophylactic clip closure for prevention of delayed bleeding after colorectal ESD (endoscopic submucosal dissection)Colorectal neoplasmsJPRN-UMIN000036734Osaka University Graduate School of Medicine45
Completed
Not Applicable
Investigating the effect and safety of the Satisphere™ insert in overweight patientsObesityISRCTN81340421Endosphere Inc (USA)60
Completed
Not Applicable
Multicenter prospective study on effectiveness of color visual field testHealthy patient without ophthalmologic disease, glaucoma, early diabetic retinopathy, branch retinal vein occlusion, central retinal vein occlusion, central serous chorioretinopathy, epiretinal membrane, and macular holeJPRN-UMIN000029280Yuya Sato Eye Clinic