UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034736
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last 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
Email n-sugano@umin.net

Public contact
1st 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
Email w-ando@umin.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine, Orthopedic Medical Engineering
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039602

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.