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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013745

Enrollment

Registered

2014-04-17

Start date

2014-04-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoporosis after gastrectomy

Interventions

oral alendronate (35mg/week) for 12 months intravenous alendronate (900ug/4week) + vit-D3 (1.0ug/day) for 12 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients who underwent gastrectomy within five years. 2. Pathological stageI patients or stages II/III patients without recurrence for at least three years after surgery. 3. Bone mineral density <80% of the YAM (young adult mean) assessed by dual-energy x-ray absorptiometry. 4. Age 20 years and over. 5. Eastern Cooperative Oncology Group (ECOG) PS 0 or 1 6. Serum levels of alkaline phosphatase, calcium, phosphorus, 1,25-dihydroxyvitamin D3 and undercaboxylated osteocalcin were within the normal range. 7. Signed informed consent documents

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change of bone mineral density after one year administration of alendronate	—

Secondary

Measure	Time frame
Compliance of alendronate and activated vitamin-D3 Adverse events of alendronate and activated vitamin-D3	—

Countries

Japan

Contacts

Public ContactTakanobu Yamada

Kanagawa Cancer Center Department of Gastrointestinal Surgery

tknbymd@kcch.jp045-520-2222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026