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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016158
Receipt No. 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

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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
Email 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
Email naomik58@aol.com

Sponsor
Institute Yokohama City University
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 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
URL(English) https://upload.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
Registered date File name


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