Postmenopausal osteoporosis
Conditions
Interventions
Raloxifene (60mg/day)
Eldecalcidol (0.75micro
g/day)
Raloxifene (60mg/day) +eldecalcidol (0.75micro
Sponsors
Kyushu-University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Postmenopausal state more than 5 years 2. Criteria of osteoporosis (The guide of lifestyle-related diseases fracture risk Have any existing insufficiency fracture (over 50 years old) Have no any existing insufficiency fractur (%YAM<70) Postmenopausal women who have no existing insufficiency (70<%YAM<80) and satisfying at least one of the following requirements (1) Family history of bone fracture of proximal part of femur (2) Primary osteoporotic fracture, 10-year fracture risk assessment more than 15% and less than 75 years old using FRAX (3) Fracture risk assessment of lifestyle related disease (type 2 diabetes mellitus, CKD stage 3 or more advanced)
Exclusion criteria
Exclusion criteria: The following subjects will be excluded from the study: 1.Pregnants women, women suspected of being pregnant, or lactating women 2.Patients who have been diagnosed or history of thromboembolism (including deep vein thrombosis, pulmonary embolism, retinal vein occlusion) 3.Patients who is a long term and immovable 4.Patients who is an antiphospholipid syndrome 5.Patients who have a hypersensitivity to Raloxifene or Eldecalcidol 6.Patients who are treated with bisphosphonates, or within 3 month after the suspension of administration 7.Patients whom the principle investigators or other investigators consider unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect on improving insulin resistance: changes of HOMA-IR at 12 months Effect on improving arteriosclerosis: changes of BMD at 12 month | — |
Countries
Japan
Contacts
Public ContactKyouko Okada
Kyushu-University Hospital Department of General internal medicine
Outcome results
None listed