post-menopausal women with osteoporosis and CKD stage 3
Conditions
Interventions
raloxifene
eldecalcitol
raloxifene and eldecalcitol
Sponsors
Osaka City University Graduate School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1)Women diagnosed as primary osteoporosis by The Japanese Society for Bone and Mineral Research Criteria 2012. (2)Post-menopausal women or women post ovariectomy (3)eGFR 30-60ml/min (CKD stage 3) (4)40 years old to 75 years old at informed consent (5)Ambulatory outpatient (6)Patients who are fully informed of and understand the objectives, procedures, and possible risks of the study and provide the written voluntary consent to participate in the study
Exclusion criteria
Exclusion criteria: (1)Patients treated with Bisphosphonates within 48 weeks of the enrollment. (2)Patients who have been treated with parathyroid hormone, anti-RANKL antibody or Kathepsin K inhibitors. (3)Patients who have been treated with medication which may affect to the bone metabolism as follows within 8 weeks of the enrollment, except calcium preparations, (a)Active vitamin D including external drugs (b)Selective Estrogen Receptor Modulators (SERM) (c)Calcitonin preparations (d)Vitamin K2 preparations (e)Ipriflavone preparations (f)Sex hormones except virginal tablet or virginal balm (g)Steroid preparations except inhaler, nasal drip, external drugs or local injection. (h) Warfarin (i)Other drugs which affect to the bone metabolism (4)Patients who have Diabetes Mellitus (5)Patients treated with other test drugs (including placebo) within 16 weeks of the enrollment. (6)Patients who have findings that may affect to the evaluation of bone mineral density in lumbar vertebra or hip, as follows (a)Patients who have bone fracture or severe deformity in L2-4 or hip (b)Patients who have degenerations or severe osteosclerosis in L2-4 or hip (c)Patients who have severe extra-vertebral calcifications in L2-4 (d)Patients who have other abnormal findings that may affect to the evaluation of bone mineral density in lumbar vertebra (7)Patients who have history of deep vein thrombosis, pulmonary thromboembolism or occlusion of retinal vein (8)Patients whose total serum calcium corrected for albumin levels are over +0.5mg/dL of upper limit or whose Ca/Crelevels are over 0.3 (9)Patients who have history of ureteral stones (10)Patients who have cancer (11)Patients who have severe liver dysfunction (12)Patients who have severe heart dysfunction (13)Patients who have drug hypersensitivity to SERM or Vitamin D preparations (14)Patients judged as unsuitable for the study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone index (BMD, cortical thickness, EM-tb) at the 48th weeks from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone index at the 24th weeks from baseline Bone markers (Ca, P, 1,25D, wholePTH, intact-PTH, BAP, P1NP, TRACP-5b, FGF-23) Lipid profiles (TC, TG, HDLC, LDLC) Index of atherosclerosis (IMT, PWV FMD) Index of renal function (eGFRcre, eGFRcystatin, urinary Alb) Vertebral fractures | — |
Countries
Japan
Contacts
Public ContactKatsuhito Mori
Osaka City University Graduate School of Medicine Department of Metabolism, Endocrinology, and Molecular Medicine, Nephrology
Outcome results
None listed