UMIN-CTR Clinical Trial

Basic information
Public title	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
Acronym	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
Scientific Title	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
Scientific Title:Acronym	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
Region	Japan

Condition
Condition	post-menopausal women with osteoporosis and CKD stage 3
Classification by specialty	Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to examine the benefit of combination therapy of eldecalcitol and raloxifene on osteoporosis in post-menopausal women with CKD stage 3, compared to the monotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Bone index (BMD, cortical thickness, EM-tb) at the 48th weeks from baseline
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	raloxifene
Interventions/Control_2	eldecalcitol
Interventions/Control_3	raloxifene and eldecalcitol
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	75 years-old >=
Gender	Female
Key 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
Key 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
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Masaaki Middle name Last name Inaba
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Metabolism, Endocrinology, and Molecular Medicine, Nephrology
Zip code	5458585
Address	1-4-3 Asahi-machi, Abeno-ku, Osaka City
TEL	+85-6-6645-3806
Email	m1356849@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Katsuhito Middle name Last name Mori
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Metabolism, Endocrinology, and Molecular Medicine, Nephrology
Zip code	5458585
Address	1-4-3 Asahi-machi, Abeno-ku, Osaka City
TEL	+85-6-6645-3806
Homepage URL
Email	ktmori@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Eli Lilly Japan K.K
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka City University Graduate School of Medicine
Address	Abenoku Asahimachi 1-4-3 Osaka Japan
Tel	0666453806
Email	m1399776@med.osaka-cu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪市立大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 13 Day

Related information
URL releasing protocol	0000
Publication of results	Unpublished

Result
URL related to results and publications	0000
Number of participants that the trial has enrolled	0
Results	study terminated
Results date posted	2022 Year 07 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	study terminated
Participant flow	study terminated
Adverse events	study terminated
Outcome measures	study terminated
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 05 Month 01 Day
Date of IRB	2015 Year 07 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 13 Day
Last follow-up date	2020 Year 07 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 13 Day
Last modified on	2022 Year 07 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021054