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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027501
Receipt No. R000031501
Scientific Title Efficacy of Alendronate for the Prevention of Bone Loss in Calcar Region Following Total Hip Arthroplasty.
Date of disclosure of the study information 2017/05/26
Last modified on 2017/05/26

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Basic information
Public title Efficacy of Alendronate for the Prevention of Bone Loss in Calcar Region Following Total Hip Arthroplasty.
Acronym Alendronate for the Prevention of Bone Loss around Total Hip Arthroplasty.
Scientific Title Efficacy of Alendronate for the Prevention of Bone Loss in Calcar Region Following Total Hip Arthroplasty.
Scientific Title:Acronym Alendronate for the Prevention of Bone Loss around Total Hip Arthroplasty.
Region
Japan

Condition
Condition Osteoarthritis of hip joint
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Bone mineral density loss around femoral implants, particularly in the proximal femur, is a common outcome after total hip arthroplasty. Previous studies reported the prevention of postsurgical decreases in bone mineral density with the use of osteoporosis drug therapy. This randomized study evaluates the efficacy of alendronate and alfacalcidol for preserving bone mineral density over long-term follow-up.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Periprosthetic bone mineral density measured by dual-energy X-ray(Postoperative 1-year, 2-year, 8 to 9-year)
Key secondary outcomes Occurrence of aseptic loosening and periprsthetic fracture

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of alendronate(5mg/day) after total hip arthroplasty atleast 2 years.
Interventions/Control_2 Administration of alphacalcidolfollowing(0.001g/day) total hip arthroplasty atleast 2 years.
Interventions/Control_3 No medication after surgery at least 2 years.
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 Patients who underwent primary total hip arthroplasty for osteoarthritis at our institute
Key exclusion criteria (a) a history of disorder(s) that might affect bone or mineral metabolism, (b) gastrointestinal disease, (c) renal dysfunction, (d) taking any agents for osteoporosis, (e) taking corticosteroids, and (f) perioperative fracture of femur that required additional fixation using plates and wires.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukizawa, Yohei
Organization Yokohama City University
Division name Orthopaedic Surgery
Zip code
Address 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa Japan
TEL 045-787-2600
Email snowriverjp@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Inaba, Yutaka
Organization Yokohama City University
Division name Orthopaedic Surgery
Zip code
Address 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa Japan
TEL 045-787-2600
Homepage URL
Email yute0131@med.yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Yokohama City University
Organization
Division
Category of Funding Organization Other
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
2017 Year 05 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

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
2006 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 15 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 26 Day
Last modified on
2017 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031501

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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