UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011992 |
|---|---|
| Receipt number | R000014017 |
| Scientific Title | Efficacy and safety of denosumab for the treatment of osteoporosis in patients with renal failure |
| Date of disclosure of the study information | 2013/10/08 |
| Last modified on | 2019/04/13 10:50:42 |
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Basic information
Public title
Efficacy and safety of denosumab for the treatment of osteoporosis in patients with renal failure
Acronym
Efficacy and safety of denosumab for the treatment of osteoporosis in patients with renal failure
Scientific Title
Efficacy and safety of denosumab for the treatment of osteoporosis in patients with renal failure
Scientific Title:Acronym
Efficacy and safety of denosumab for the treatment of osteoporosis in patients with renal failure
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the safety and efficacy of denosumab for the treatment of osteoporosis in patients with renal dysfunction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Change of bone mineral density (BMD) at lumbar supine and femoral neck
Key secondary outcomes
Side effect, rate of continuation, change of bone metabolic markers, and serum calcium.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
60 mg of denosumab s.c every 6 months
Interventions/Control_2
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
CKD patients (eGFR<60 ml/min) with osteoporosis (T score <2.5).
Key exclusion criteria
CKD patients with corrected calcium (cCa)<8.5 mg/dl or serum PTH> 110 pg/ml.
Patients with dialysis whose serum Ca, P, and PTH are out of the range recommended by JSDT 2012 (cCa 8.5-10.0 mg/dl, P 3.5-6.0 mg/dl, and PTH 60-240 pg/ml)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenmei Takaichi |
Organization
Toranomon Hospital
Division name
Nephrology Center
Zip code
Address
2-2-2, Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
takaichi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Hoshino |
Organization
Toranomon Hospital Kajigaya
Division name
Nephrology Center
Zip code
Address
1-3-1, Kajigaya, Takatsu-ku, Kawasaki, Kanagawa
TEL
044-877-5111
Homepage URL
jhoshino-ind@umin.ac.jp
Sponsor or person
Institute
Nephrology Center, Toranomon Hospital
Nephrology Center, Toranomon Hospital Kajigaya
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
虎の門病院（東京都）、虎の門病院分院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 11 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 11 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 08 | Day |
Last modified on
| 2019 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014017
