UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035653 |
|---|---|
| Receipt number | R000040613 |
| Scientific Title | Denosumab prevents periprosthetic bone mineral density loss in the tibial metaphysis in total knee arthroplasty |
| Date of disclosure of the study information | 2019/01/25 |
| Last modified on | 2019/01/24 09:48:05 |
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Basic information
Public title
Denosumab prevents periprosthetic bone mineral density loss in the tibial metaphysis in total knee arthroplasty
Acronym
The effect of denosumab in periprosthetic bone mineral density
Scientific Title
Denosumab prevents periprosthetic bone mineral density loss in the tibial metaphysis in total knee arthroplasty
Scientific Title:Acronym
The effect of denosumab in periprosthetic bone mineral density
Region
| Japan |
Condition
Condition
Primary osteoarthritis of knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether denosumab treatment after total knee arthroplasty could prevent periprosthetic bone resorption in the patients of primary osteoarthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We measure periprosthetic bone mineral density using dual energy X-ray absorptiometry after total knee arthroplasty for 12 months.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients in the intervention group received 0.5 ug vitamin D3 (Alfacalcidol) daily and 60 mg denosumab every 6 months from the day after total knee arthroplasty for 12 months.
Interventions/Control_2
Patients in the control group received 0.5 ug active vitamin D3 (Alfacalcidol) daily from the day after total knee arthroplasty for 12 months.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We include only patients with osteoporosis and primary osteoarthritis of the knee.
Key exclusion criteria
We exclude patients who are undergoing revision surgery, and those who had previously taken anti-osteoporotic drugs or other medications known to influence bone mineral metabolism.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Teramoto |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
S-1, W-16, Chuo-ku, Sapporo, 060-8543, Hokkaido, Japan
TEL
01161112111(33330)
teramoto.atsushi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasutaka Murahashi |
Organization
Sapporo Medical Univ. School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
S-1, W-16, Chuo-ku, Sapporo, 060-8543, Hokkaido, Japan
TEL
01161112111(33330)
Homepage URL
yayayaya1126@yahoo.co.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
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
札幌医科大学附属病院(北海道) Sapporo Medical University Hospital
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 25 | 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
| 2014 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 27 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 27 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 24 | Day |
Last modified on
| 2019 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040613
