UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028169 |
|---|---|
| Receipt number | 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 | 2022/07/25 15:11:01 |
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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
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
hyonmin@hotmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
| 2016 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 25 | Day |
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
| 2022 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032240
