UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination for the effect of combination therapy with Eldecalcitol and Alendronate in primary osteoporotic patients
Title of the study (Brief title)	Examination for the effect of combination therapy with Eldecalcitol and Alendronate in primary osteoporotic patients
Region	Japan

Condition
Condition	Osteoporosis
Classification by specialty	Endocrinology and Metabolism Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect and safety in primary osteoporotic patients undergoing therapy with Alendronate by adding Eldecalcitol
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Change of lumbar spine bone mineral density
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Alendronate (35mg/week) + Eldecalcitol (0.75ug/day) for 48 weeks
Interventions/Control_2	Alendronate (35mg/week)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Primary osteoporotic patients 2.Patients who are treated with Alendronate for more than two years 3.Patients with informed of consent
Key exclusion criteria	1. Patients who are diagnosed as contraindication of Alendronate treatments 2. Patients who are diagnosed as contraindication of Eldecalcitol treatments 3.Patients who have taken osteoporosis treatments other than Alendronate 4.Patients with cancer 5. Patients who are inappropriate for this study by physician
Target sample size	100

Research contact person
Name of lead principal investigator	Takashi Nagai
Organization	Showa University
Division name	Department of Orthopaedic Surgery
Address	1-5-18 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8543
Email	nagai.babby@gmail.com

Public contact
Name of contact person	Takashi Nagai
Organization	Showa University
Division name	Department of Orthopaedic Surgery
Address	1-5-18 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8543
Homepage URL
Email	nagai.babby@gmail.com

Sponsor
Institute	Showa University
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)

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	昭和大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 16 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2017 Year 11 Month 30 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	2012 Year 06 Month 18 Day
Last modified on	2017 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009653