UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014074 |
|---|---|
| Receipt number | R000016382 |
| Scientific Title | The effect of improving the bone density at the surrounding total knee arthroplasty by Human Parathyroid Hormone (PTH) |
| Date of disclosure of the study information | 2014/05/26 |
| Last modified on | 2017/07/22 10:32:39 |
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Basic information
Public title
The effect of improving the bone density at the surrounding total knee arthroplasty by Human Parathyroid Hormone (PTH)
Acronym
The effect of improving the bone density at the surrounding TKA by PTH
Scientific Title
The effect of improving the bone density at the surrounding total knee arthroplasty by Human Parathyroid Hormone (PTH)
Scientific Title:Acronym
The effect of improving the bone density at the surrounding TKA by PTH
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study that previously conducted suggested that reduced bone density of surround the specific part of artificial knee joint.It cause the fracture of that with high potentiality.
This time, we investigate of improvement effect of the bone atrophy at surround the artificial knee joint by Human Parathyroid Hormone,among the patient who has osteoporosis and was post-operation of total knee arthroplasty.In addition to improvement effect on the clinical evaluation of osteoporosis or knee joint.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Investigation of improvement effect the bone atrophy of surround the artificial knee joint by Human Parathyroid Hormone
Key secondary outcomes
Investigation of improvement effect on the clinical evaluation of osteoporosis or knee joint by Human Parathyroid Hormone
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Human Parathyroid Hormone is administered by subctaneous injection(20 microgram with single daily dosing during 2 year or 56.5 microgram with single weekly dosing during 1.5 year)
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
1)Osteoporosis patient who is postoperative total knee arthroplasty and administered the Human Parathyroid Hormone.
2)Patient who is a subject of the present study and consented to the data provided.
Key exclusion criteria
1)Patient who is suspected of being pregnant or pregnant women
2)Patient who is difficult to communicate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Sukesaki MD |
Organization
Showa university Hospital
Division name
Orthopedics
Zip code
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
TEL
03-3784-8543
tatsuyawahaha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumio Sukesaki |
Organization
Showa university Hospital
Division name
Orthopedics
Zip code
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
TEL
03-3784-8543
Homepage URL
tatsuyawahaha@yahoo.co.jp
Sponsor or person
Institute
Showa university Hospital Department of Orthopedics
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
| 2014 | Year | 05 | Month | 26 | 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
At the time of the end for six months, it was recognized that the influence on bone metabolism with the PTH dosage in drawing blood data , but not recognized the rise in bone density of the region of interest.
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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 07 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 07 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 07 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 26 | Day |
Last modified on
| 2017 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016382
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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