UMIN-CTR Clinical Trial

Basic information
Public title	Examination for the effect of combination therapy with alendronate and eldecalcitol in primary osteoporotic patients :A randomized active comparator study -Switch from alfacalcidol to eldecalcitol-
Acronym	Examination for the effect of combination therapy with alendronate and eldecalcitol for osteoporosis -Switch from alfacalcidol to eldecalcitol-
Scientific Title	Examination for the effect of combination therapy with alendronate and eldecalcitol in primary osteoporotic patients :A randomized active comparator study -Switch from alfacalcidol to eldecalcitol-
Scientific Title:Acronym	Examination for the effect of combination therapy with alendronate and eldecalcitol for osteoporosis -Switch from alfacalcidol to eldecalcitol-
Region	Japan

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

Objectives
Narrative objectives1	To examine the BMD increase at lumbar spine in primary osteoporotic patients who had taken combination therapy with alendronate and alfacalcidol by switching from alfacalcidol to eldecalcitol.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of lumbar spine bone mineral density
Key secondary outcomes	Change of total hip bone mineral density Number of fracture occurred Change of bone metabolic markers Safety

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	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Alendronate (35mg/week) + alfacalcidol (1.0ug/day) for 48 weeks
Interventions/Control_2	Alendronate (35mg/week) + eldecalcitol (0.75ug/day) for 48 weeks
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	(1) Primary osteoporotic patients (2) Patients who are treated with alendronate and alfacalcidol for more than 24 weeks and less than five 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 are treated with glucocorticoid (4) Patients who have serum calcium levels of above 10.5mg/dL (5) Patients who have taken osteoporosis treatments other than alendronate and alfacalcidol (6) Patients who are inappropriate for this study by physician
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Junji Chiba
Organization	Tokyo Women's Medical University Medical Center East
Division name	Department of Orthopaedic Surgery
Zip code
Address	2-1-10 Nishiogu, Arakawa, Tokyo, Japan
TEL	03-3810-1111
Email

Public contact
Name of contact person	1st name Middle name Last name Yasuo Inoue
Organization	Tokyo Women's Medical University Medical Center East
Division name	Department of Orthopaedic Surgery
Zip code
Address	2-1-10 Nishiogu, Arakawa, Tokyo, Japan
TEL	03-3810-1111
Homepage URL
Email	i-yasuo2@apr.so-net.jp

Sponsor
Institute	Tokyo Women's Medical University Medical Center East
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

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 27 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	2011 Year 12 Month 26 Day
Date of IRB	2011 Year 11 Month 13 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2014 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 12 Month 27 Day
Last modified on	2021 Year 01 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008223