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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004847
Receipt No. 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 2011/01/09

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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
Email

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
Email u-sakamo@juntendo.ac.jp

Sponsor
Institute Juntendo University Nerima Hospital
Institute
Department

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
Email

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
Results
Oral presentation at The 37th Annual Meeting of Japanese Hip Society 
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 No longer recruiting
Date of protocol fixation
2007 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 04 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
2011 Year 01 Month 09 Day
Last modified on
2011 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002436

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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