Impact of raloxifene, eldecalcitol and their combination therapy on bone indices in postmenopausal subjects with osteoporosis and chronic kidney disease stage 3: Re Bone Study

Not Applicable

• Conditions: post-menopausal women with osteoporosis and CKD stage 3

• Registration Number: JPRN-UMIN000018296
• Lead Sponsor: Osaka City University Graduate School of Medicine

Brief Summary

study terminated

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-13
• Study Completion: 2020-07-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified