UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020381 |
|---|---|
| Receipt number | R000023276 |
| Scientific Title | The effect of osteoporosis drug against bone remodeling around femoral implant after total hip arthroplasty |
| Date of disclosure of the study information | 2016/01/04 |
| Last modified on | 2015/12/16 16:25:53 |
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Basic information
Public title
The effect of osteoporosis drug against bone remodeling around femoral implant after total hip arthroplasty
Acronym
THA bone remodeling study
Scientific Title
The effect of osteoporosis drug against bone remodeling around femoral implant after total hip arthroplasty
Scientific Title:Acronym
THA bone remodeling study
Region
| Japan |
Condition
Condition
hip osetoarthritis
Osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of osteoporosis drug against bone mineral density loss around femoral implant after cementless total hip arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
% change in bone mineral density in zone 7 based on zones of Gruen et al. at 12 months after cementless total hip arthroplasty in groups treated denosumab therapy compared the control groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral alfacalcidol + inject denosumab 60mg subcutaneously every six months
Interventions/Control_2
Oral alfacalcidol
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)patients with osteoarthritis of hip who are undergoing a primary total hip arthroplasty
2)BMD T score <-2.5%
3)patients who obtained informed consent in our study
Key exclusion criteria
1)hypocalcemia
2)hypercalcemia
3)patients who are allergic to the study drug
4)patients who had liver dysfunction or renal dysfunction
5)patients who fractured in surgery
6)patients who has been determined to be inappropriate by Officer
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Miyazaki |
Organization
Mie University Hospital
Division name
Orthopaedics
Zip code
Address
2-174 Edobashi Tsu, Mie, Japan
TEL
059-231-1111
shinmiya@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Miyazaki |
Organization
Mie University Hospital
Division name
Orthopaedics
Zip code
Address
2-174 Edobashi Tsu, Mie, Japan
TEL
059-231-1111
Homepage URL
shinmiya@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital
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
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
| 2016 | Year | 01 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | 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
| 2015 | Year | 12 | Month | 28 | Day |
Last modified on
| 2015 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023276
