UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Denosumab and Alendronate on osteoporosis in hemodialysis patients :a randomized controlled trial
Title of the study (Brief title)	Effect of Denosumab and Alendronate on osteoporosis in hemodialysis patients :a randomized controlled trial
Region	Japan

Condition
Condition	osteoporosis
Classification by specialty	Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the effect of denosumab and alendronate on osteoporosis in hemodialysis patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percent change of bone mineral density (BMD) in lumber spine, femoral neck and distal radius at 6, 12 month after intervention
Key secondary outcomes	Percent change of bone metabolism markers, rate of continuation, side effect at 6, 12 month after intervention

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	denosumab (60 mg) subcutaneously every 6 months
Interventions/Control_2	Alendronate (900 maicrog) by Intravenous administration every 4 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) Hemodialysis patient whose age is not less than 20 years old 2) A written informed consent is obtained. 3) Patients whose T-score is not greater than -2.5 or YAM is less than 70%. Patients with an existing insufficiency whose YAM is less than 80%. 4) Patients who have maintained dialysis therapy for over 6 months 5) Patients whose i-PTH is 60-240.
Key exclusion criteria	) Patients who are considered to be contraindicated for denosumab. 2) Patients who are considered to be contraindicated for alendronate. 3) Cancer patients. 4) Patients who have pretreated with bisphosphonate in recent 6 months. 5) Patients who have pretreated with denosumab in recent 6 months. 6) Patients whose corrected Ca is less than 8.4 mg/dL. 7) Patients with severe liver disease 8) Patients with severe heart disease 9) Patients may be pregnant 10) Patients who have bad oral consitions 11) Patients who are thought to be inappropriate for this study by physician.
Target sample size	80

Research contact person
Name of lead principal investigator	Makoto Watanabe
Organization	Makita general hospital
Division name	Internal medicine
Address	1-34-6 Omorikita, Ohta-ku, Tokyo
TEL	03-3762-4671
Email	makotonb@med.showa-u.ac.jp

Public contact
Name of contact person	Ken Iseri
Organization	Makita general hospital
Division name	Internal medicine
Address	1-34-6 Omorikita, Ohta-ku, Tokyo
TEL	03-3762-4671
Homepage URL
Email	iseriken@med.showa-u.ac.jp

Sponsor
Institute	Makita general hospital
Institute
Department

Funding Source
Organization	The Kidney Foundation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Haneda oozora Clinic Adachimotoki jin Clinic Heiwa Hospital
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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 10 Day
Anticipated trial start date	2016 Year 07 Month 10 Day
Last follow-up date
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 02 Day
Last modified on	2018 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026492