UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027501 |
|---|---|
| Receipt number | 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 14:38:42 |
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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
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
yute0131@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031501
