UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018048 |
|---|---|
| Receipt number | R000018978 |
| Scientific Title | Preventive efficacy of post-operative fracture after a total knee replacement: comparative study of PTH and anti-RANKL treatment |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2015/06/23 21:15:50 |
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Basic information
Public title
Preventive efficacy of post-operative fracture after a total knee replacement: comparative study of PTH and anti-RANKL treatment
Acronym
Preventive efficacy of post-operative fracture after a total knee replacement: comparative study of PTH and anti-RANKL treatment
Scientific Title
Preventive efficacy of post-operative fracture after a total knee replacement: comparative study of PTH and anti-RANKL treatment
Scientific Title:Acronym
Preventive efficacy of post-operative fracture after a total knee replacement: comparative study of PTH and anti-RANKL treatment
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our objective of this study is to evaluate osteoporosis and fracture risk of patients undergoing TKA surgery and to investigate a preventive efficacy of post-operative fracture with PTH and anti-RANKL treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
new fragility fracture
bone mineral density by DEXA
bone formation and resorption marker
Key secondary outcomes
change of bone mineral density around the implant after TKA
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
teriparatide
Interventions/Control_2
denosumab
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with osteoporosis undergoing total knee replacement
provided a consent to participate in this study
Key exclusion criteria
patients undergoing treatment for osteoporosis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki Okumura |
Organization
Shiga University of Medical Science
Division name
Orthopaedic Surgery
Zip code
Address
Seta, Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2252
noriaki@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriaki Okumura |
Organization
Shiga University of Medical Science
Division name
Orthopaedic Surgery
Zip code
Address
Seta, Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2252
Homepage URL
noriaki@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
| 2015 | Year | 07 | Month | 01 | 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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | 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
| 2015 | Year | 06 | Month | 23 | Day |
Last modified on
| 2015 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018978
