Phase II randomized trial of alendronate to compare oral and intravenous administration for bone mineral density in gastrectomized patients

Phase 2

• Conditions: osteoporosis after gastrectomy

• Registration Number: JPRN-UMIN000013745
• Lead Sponsor: Kanagawa Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-17
• Study Completion: 2020-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients who received local resection of the stomach 2. Patients who receive chemotherapy due to recurrent or remnant gastric cancer 3. Passage disturbance of esophagus due to achalasia or mechanical stenosis 4. Uncontrolled reflux esophagitis even by medication 5. Renal dysfunction or serum creatinine 1.5mg/dL or less 6. Scoliosis or compressed fracture of lumbar spine 7. Patients who received or plans extraction of tooth within three months 8. Previous treatment of bisphosphonate within six months 9. Patients who receive thyroid hormone or antithyroid hormone 10. Diabetes mellitus controlled by insulin 11. Patients who receive warfarin 12. Patients who receive any medication affecting bone metabolism. 13. Patients who have mental disorder or severe mental symptom 14. Allergy to the alendronate and vitamin D3 15. Other active malignancy occurring within 5 years before enrollment 16. Patients who are judged as inappropriate for study entry by the investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of bone mineral density after one year administration of alendronate

Secondary Outcome Measures

Name	Time	Method
Compliance of alendronate and activated vitamin-D3 Adverse events of alendronate and activated vitamin-D3