Prospective observational study for the impact of short-term periodic intravenous steroid premedication for gastrointestinal cancer chemotherapy on bone metabolism.
Not Applicable
- Conditions
- Gastrointestinal cancer: Colorectal cancer, Non-colorectal cancer (Gastroesophageal, Pancreatic, and Biliary tract cancer)
- Registration Number
- JPRN-UMIN000011054
- Lead Sponsor
- Hokkaido Gastrointestinal Cancer Study Group: HCGSC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
Exclusion Criteria
1) Take some steroids regularly already. 2) Take some bisphosphonates regularly already. 3) Take some calcium regularly already. 4) Regimens with steroid free interval over 4 weeks.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the variations of bone mineral densities (DEXA) and bone turnover markers (NTX and BAP) between baseline and 16 weeks after.
- Secondary Outcome Measures
Name Time Method Comparing each groups of weekly, biweekly, and triweekly administrations of steroid. The serum levels of albumin, calcium(Ca), phosphorus, fasting blood glucose, and creatinine(Cr), as well as urinary Ca and Cr measured on the indicated days: baseline, day 3, 7, 14, and 28 Site of a primary cancer Regimens Total amounts of steroids Dose intensity of steroids Newly bone fractures