UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016158 |
|---|---|
| Receipt number | R000018750 |
| Scientific Title | Comparison of alendronate and teriparatide for the bone mineral density around implant after total hip arthroplasty |
| Date of disclosure of the study information | 2015/01/09 |
| Last modified on | 2015/01/08 11:34:12 |
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Basic information
Public title
Comparison of alendronate and teriparatide for the bone mineral density around implant after total hip arthroplasty
Acronym
RCT for BMD loss after THA
teriparatide vs alendronate
Scientific Title
Comparison of alendronate and teriparatide for the bone mineral density around implant after total hip arthroplasty
Scientific Title:Acronym
RCT for BMD loss after THA
teriparatide vs alendronate
Region
| Japan |
Condition
Condition
cases after primary total hip arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of teriparatide for the prevention of BMD loss after THA comparing with alendronate in a randomized controlled trial
Basic objectives2
Others
Basic objectives -Others
Comparison of bone metabolism markers
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of bone mineral density in teriparatide treatment, alendronate treatment, and control group
Key secondary outcomes
Change of bone formation markers in teriparatide treatment, alendronate treatment, and control group
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
teriparatide daily administration (Forteo 20 ug, Eli Lilly Japan K.K.) beginning on postoperative week 2 and continuing until week 48
Interventions/Control_2
weekly administration of alendronate (Bonalon 35 mg, Teijin Pharma Limited)
beginning on postoperative week 2 and continuing until week 48
Interventions/Control_3
no medication
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Primary total hip arthroplasty cases
applicable for standardized implant
under informed consent
Key exclusion criteria
cases of malignant tumor
cases with difficulty of one year follow-up
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naomi Kobayashi |
Organization
Yokohama City University
Division name
Orthopaedic surgery
Zip code
Address
3-9 Fukuuram Kanazawa-ku, Yokohama, Japan
TEL
045-787-2655
naomik58@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naomi Kobayashi |
Organization
Yokohama City University
Division name
Orthopaedic surgery
Zip code
Address
3-9 Fukuuram Kanazawa-ku, Yokohama, Japan
TEL
045-787-2655
Homepage URL
naomik58@aol.com
Sponsor or person
Institute
Yokohama City University
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
横浜市立大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 09 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 10 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 08 | Day |
Last modified on
| 2015 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018750
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
