UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of calcium, Vitamin D, and denosumab on osteoporosis and basal metabolism in postmenopausal diabetic women
Title of the study (Brief title)	The effect of denosumab on basal metabolism in type 2 diabetic women
Region	Japan

Condition
Condition	Type 2 Diabetes Mellitus, Osteoporosis
Classification by specialty	Medicine in general Endocrinology and Metabolism Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the change of the basal metabolism, glucose control and bone metabolism in patients with type 2 diabetes by improvement of osteoporosis with Calcium/vitamin D and Denosumab.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes of the Basal metabolism, and the marker of the bone metabolism before and after taking Calcium/Vitamin D and denosumab
Key secondary outcomes	Changes of the blood glucose control level, fasting CPR, iPTH, 25hydroxyvitamin D, blood cell count, serum calcium, phosphate and other general examination of blood, and diabetic neuropathy

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	Calcium / Vitamin D / Magnesium mixed tablet ; Calcium 305mg, Cholecalciferol 0.005mg (200IU), Magnesium carbonate 59.2mg is containing per tablet. Taking 2 tablet / day prior 1 month from Denosumab 60mg injection to subcutaneous, once per 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	50 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patient of type 2 Diabetes Mellitus 1: More than 50 years of age at the time of obtaining informed consent 2:With osteoporosis 3: At the participation in this study, that document consent is obtained due to free will of the patient's own by sufficient explanation and thorough understanding. 4:Control of blood pressure and blood glucose are relatively stable, and without planning for remarkable change.
Key exclusion criteria	The patients who Taking drug for osteoporosis With presence and past history of malignancy. With other endocrine diseases With liver dysfunction except fatty liver With macro proteinuria or with increased serum creatinine level over 2.0mg/dl Principal investigator of this study has determined to be inappropriate as a subject
Target sample size	50

Research contact person
Name of lead principal investigator	Yasuko Uchigata
Organization	Tokyo Women's Medical University
Division name	Diabetes Center
Address	8-1,Kawadacho Shinjyukuku Tokyo 1628666 Japan
TEL	03-3353-8111
Email	uchigata.dmc@twmu.ac.jp

Public contact
Name of contact person	Makiko Ogata
Organization	Tokyo Women's Medical University
Division name	Diabetes Center
Address	8-1,Kawadacho Shinjyukuku Tokyo 1628666 Japan
TEL	03-3353-8111
Homepage URL
Email	mogatamd.dmc@twmu.ac.jp

Sponsor
Institute	Tokyo Women's Mediclcal University
Institute
Department

Funding Source
Organization	Diabetes Center, Tokyo Women's Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

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	東京女子医科大学病院糖尿病センター（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 22 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 01 Month 20 Day
Anticipated trial start date	2015 Year 03 Month 19 Day
Last follow-up date	2017 Year 04 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 22 Day
Last modified on	2017 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017833