The combination therapy with Eldecalcitol and Ibandronate sodium

JRCT ID: jRCT1041200059

Registered date:06/11/2020

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Patients diagnosed with osteopenia among patients with gastric cancer after gastrectomy
• Date of first enrollment: 06/11/2020
• Target sample size: 70
• Study type: Interventional

Intervention(s)

[Test drug]
Intravenous 1 mg of Bombiva as ibandronic acid is administered intravenously once a month.
[Control drug]
Bombiva Tablets 100 mg as ibandronic acid is orally administered once a month with a sufficient amount (about 180 mL) of water when waking up.

[Concomitant drug]
Orally administer 0.75 ug of Edilol capsules as eldecalcitol once daily.

Outcome(s)

• Primary Outcome: Bone marrow density of lumbar bone

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Murakami Hideki