UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018296 |
|---|---|
| Receipt number | R000021054 |
| 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 |
| Date of disclosure of the study information | 2015/07/13 |
| Last modified on | 2022/07/18 14:22:47 |
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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
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
ktmori@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021054
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