The combination therapy with Eldecalcitol and Ibandronate sodium

Phase 2

Suspended

• Conditions: Patients diagnosed with osteopenia among patients with gastric cancer after gastrectomy; Gastirc cancer, osteoporosis; D013274

• Registration Number: JPRN-jRCT1041200059
• Lead Sponsor: Murakami Hideki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

(1) Patients who have undergone gastrectomy due to gastric cancer (total gastrectomy / partial gastrectomy)
(2) Patients with prevalent bone fracture(s) in vertebrae or proximal femora. Or, cases in which the lumbar spine bone mineral density is less than 80% of the average [YAM in proximal femur is substituted for elderly patients with severe deformity in vertebrae]
(3) Patients whose general condition is relatively maintained with PS (Performance Status) 0-2
(4) Patients whose registration date is 20 years old or older and under 85 years old
(5) Within 6 months after surgery
(6) The latest inspection value within 14 days before registration satisfies all of the following.
Neutrophil count over 1,500 / ul
Platelet count over 100000 / ul
Total bilirubin under 1.5 mg / dL
AST (GOT) under 100 IU / L
ALT (GPT) under 100 IU / L
Serum creatinine under 1.5 mg / dL
Corrected Ca value under 10.5 mg / dL
(7) Written consent has been obtained from the individual for participation in this research

Exclusion Criteria

(1) When the surgical scope extends to organs other than the stomach (esophagus, pancreas, etc.)
(2) Patients in a long-term immobility state
(3) Pregnant women, women who may be pregnant and lactating women
(4) Patients with a history of jaw bone necrosis or high risk
(5) Patients with hypo / hypercalcemia
(6) Patients with urethral stones
(7) Patients with a history of hypersensitivity to the ingredients of the drug used
(8) Patients with distant metastasis (including patients with positive ascites cytology) at the time of registration
(9) Patients with significant loss of appetite
(10) Patients diagnosed with secondary osteoporosis
(11) Patients who have been diagnosed and treated for osteoporosis at the time of registration
(12) Other patients that the doctor in charge deems inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone marrow density of lumbar bone

Secondary Outcome Measures

Name	Time	Method
(1) Femur bone density<br>(2) Bone metabolism markers: TRACP-5b, P1NP, 25OH vitamin D concentration (ECLIA method)<br>(3) Health-related QOL<br>(4) Digestive symptoms<br>(5) Presence or absence of fracture event during medication<br>(6) Medication compliance rate