UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004847 |
|---|---|
| Receipt number | R000002436 |
| Scientific Title | The effect of Alendronate on bone mineral density in the acetabulum and proximal femur after cementless total hip arthroplasty |
| Date of disclosure of the study information | 2011/01/15 |
| Last modified on | 2023/01/18 14:21:51 |
* 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
The effect of Alendronate on bone mineral density in the acetabulum and proximal femur after cementless total hip arthroplasty
Acronym
The effect of Alendronate on bone mineral density in the acetabulum and proximal femur after cementless total hip arthroplasty
Scientific Title
The effect of Alendronate on bone mineral density in the acetabulum and proximal femur after cementless total hip arthroplasty
Scientific Title:Acronym
The effect of Alendronate on bone mineral density in the acetabulum and proximal femur after cementless total hip arthroplasty
Region
| Japan |
Condition
Condition
Post hip arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the inhibition of bone resorption by alendronate, administered after THA, can prevent the early postoperative periosthetic bone loss at acetabulum and proximal femur.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of bone mineral density in the acetabulum and proximal femur
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Medication with Alendronate
Interventions/Control_2
Control
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
Post hip arthroplasty
Key exclusion criteria
Metabolic bone disease except for osteopolosis, taking medications that could affect bone turnover (such as bisphosphonates, active vitamin D3, estrogen, calcitonin, SERM, ipriphrabones, vitamin K), renal disfunction.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Nozawa |
Organization
Juntendo University Nerima Hospital
Division name
Dept. of Orthopaedics
Zip code
Address
3-1-10 Takanodai Nerima-ku Tokyo
TEL
03-5923-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Sakamoto |
Organization
Juntendo University Nerima Hospital
Division name
Dept. of Orthopaedics
Zip code
Address
TEL
Homepage URL
u-sakamo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Nerima 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
| 2011 | Year | 01 | Month | 15 | 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
36
Results
Oral presentation at The 37th Annual Meeting of Japanese Hip Society
Results date posted
| 2023 | Year | 01 | Month | 18 | Day |
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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2006 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 09 | Day |
Last modified on
| 2023 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002436
