UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034736 |
|---|---|
| Receipt number | R000039602 |
| Scientific Title | Restoration of periprosthetic bone loss by zoledronic acid in total hip arthroplasty with osteoporosis. |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2018/11/01 14:03:10 |
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Basic information
Public title
Restoration of periprosthetic bone loss by zoledronic acid in total hip arthroplasty with osteoporosis.
Acronym
Restoration of periprosthetic bone loss by zoledronic acid in total hip arthroplasty with osteoporosis.
Scientific Title
Restoration of periprosthetic bone loss by zoledronic acid in total hip arthroplasty with osteoporosis.
Scientific Title:Acronym
Restoration of periprosthetic bone loss by zoledronic acid in total hip arthroplasty with osteoporosis.
Region
| Japan |
Condition
Condition
Osteoporotic patients treaed with Total hip arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effect and safety of zoledronic acid on restoration of periprosthetic bone loss in the osteoporotic patients with total hip arthroplasty more than fifteen years ago.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The changes of periprosthetic bone mineral density were compared and evaluated at two years.
Key secondary outcomes
Bone mineral density, bone biomarker, Japanese orthopaedic asssciation hip scpre, WOMAC were compared between groups.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
zoledronic acid
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
The 123 patitents who were treated with total hip arthroplasety using Versys Fiber Metalwere included in this study and fulfilled the criteia of osteoporosis were included in this study.
Key exclusion criteria
The criteria of osteoporosis were not fulfilled.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhiko Sugano |
Organization
Osaka University Graduate School of Medicine
Division name
Orthopedic Medical Engineering
Zip code
Address
2-2, Yamakaoka, Suita, Osaka, Japan
TEL
06-6879-3271
n-sugano@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wataru Ando |
Organization
Osaka University Graduate School of Medicine
Division name
Orthopedic Medical Engineering
Zip code
Address
2-2, Yamakaoka, Suita, Osaka, Japan
TEL
06-6879-3271
Homepage URL
w-ando@umin.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Orthopedic Medical Engineering
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine, Orthopedic Medical Engineering
Organization
Division
Category of Funding Organization
Other
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
| 2019 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | 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
| 2018 | Year | 11 | Month | 01 | Day |
Last modified on
| 2018 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039602
