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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022985
Receipt No. R000026492
Scientific Title Effect of Denosumab and Alendronate on osteoporosis in hemodialysis patients :a randomized controlled trial
Date of disclosure of the study information 2016/07/10
Last modified on 2018/04/10

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Basic information
Public title Effect of Denosumab and Alendronate on osteoporosis in hemodialysis patients :a randomized controlled trial
Acronym Effect of Denosumab and Alendronate on osteoporosis in hemodialysis patients :a randomized controlled trial
Scientific Title Effect of Denosumab and Alendronate on osteoporosis in hemodialysis patients :a randomized controlled trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Makoto Watanabe
Organization Makita general hospital
Division name Internal medicine
Zip code
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
1st name
Middle name
Last name Ken Iseri
Organization Makita general hospital
Division name Internal medicine
Zip code
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)

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
2016 Year 07 Month 10 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
2016 Year 06 Month 10 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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