UMIN-CTR Clinical Trial

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
Last 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
Email	takaichi-tky@umin.ac.jp

Public contact
1st 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
Email	jhoshino-ind@umin.ac.jp

Sponsor
Institute	Nephrology Center, Toranomon Hospital Nephrology Center, Toranomon Hospital Kajigaya
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014017