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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028169
Receipt No. R000032240
Scientific Title Effects of denosumab for bone resorption in the femur after total hip arthroplasty
Date of disclosure of the study information 2017/07/10
Last modified on 2017/07/10

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Basic information
Public title Effects of denosumab for bone resorption in the femur after total hip arthroplasty
Acronym Effects of denosumab for bone resorption in the femur after total hip arthroplasty
Scientific Title Effects of denosumab for bone resorption in the femur after total hip arthroplasty
Scientific Title:Acronym Effects of denosumab for bone resorption in the femur after total hip arthroplasty
Region
Japan

Condition
Condition patients treated with primary total hip arthroplasty
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of denosumab for inhibition of bone resorption in the femur after total hip arthroplasty.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes DEXA of the femur
Key secondary outcomes P1NP, TRAP5b
plain radiographs of the hip joint

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Denosumab: 60 mg once in 6 months by subcutaneous injection.
Eldecalcitol: 0.75 micro g once a day orally.
These 2 drugs will be continued for 2 years.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Male:20 years old or more,
Female: menopause
(2) Japanese
(3) Osteoarthritis of the hip or
Osteonecrosis of the hip
(4) No treatment of osteoporosis
(5) Independence of daily living
(6) Change of bone mineral density is
within 10% or decrease of bone
mineral density is 10% or more
between 1 year and last follow-up.
(7) Patients agree to participate in
this study with written informed consent.
Key exclusion criteria (1) Severe renal failure
(CCr:less than 30mL/min)
(2) Hypercalcemea or hypocalcemia
(3) Past history of femoral osteotomy
(4) Systemic bone disease
(5) Patients, who are considered to be
inappropriate for this study by
doctors.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Inaba
Organization Yokohama City University
Division name Department of Orthopaedic Surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL 045-787-2655
Email yute0131@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hyonmin Choe
Organization Yokohama City University
Division name Department of Orthopaedic Surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL 045-787-2655
Homepage URL
Email hyonmin@hotmail.com

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Yokohama City University
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
2017 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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 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
2017 Year 07 Month 10 Day
Last modified on
2017 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032240

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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