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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030571
Receipt No. R000034841
Scientific Title An Exploratory Randomized comparative clinical trial for the preventive effect of Denosumab versus Zoledronic acid against bone loss around femoral implants after total hip arthroplasty
Date of disclosure of the study information 2017/12/26
Last modified on 2019/06/28

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Basic information
Public title An Exploratory Randomized comparative clinical trial for the preventive effect of Denosumab versus Zoledronic acid against bone loss around femoral implants after total hip arthroplasty
Acronym An Exploratory Randomized comparative clinical trial for the preventive effect of Denosumab versus Zoledronic acid against bone loss around femoral implants after total hip arthroplasty
Scientific Title An Exploratory Randomized comparative clinical trial for the preventive effect of Denosumab versus Zoledronic acid against bone loss around femoral implants after total hip arthroplasty
Scientific Title:Acronym An Exploratory Randomized comparative clinical trial for the preventive effect of Denosumab versus Zoledronic acid against bone loss around femoral implants after total hip arthroplasty
Region
Japan

Condition
Condition Patients with hip osteoarthritis or osteonecrosis who are undergoing total hip arthroplasty.
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effectiveness and safety of Denosumab or Zoledronic acid for prevention of bone loss around femoral implants of patients undergoing total hip arthroplasty.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in bone mineral density around the femoral implants in 1 year after total hip arthroplasty.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Denosumab is administered by injection along with Eldecalcitol biannually.
Interventions/Control_2 Zoledronic acid is administered by injection along with Eldecalcitol once a year.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients diagnosed with hip osteoarthritis or necrosis and are undergoing total hip arthroplasty for the first time;
2)Patients who are using SL-PLUS MIA HA stem (Smith & Nephew) for their implants;
3)Patients who have been diagnosed with osteoporosis;
4)Men aged 20 to 79 or women aged 50 to 79
who had the last menstruation over a year ago at the time of informed consent;
5)Patients who can write the informed consent on their own.
Key exclusion criteria 1)Patients who have taken the following drugs for the treatment of osteoporosis:
a)calcium, b)female hormone, c)activated vitamin D3, d)vitamin K, e)bisphosphonate, f)SERM, g)calcitonin, h)parathyroid hormone, PTH, i)Anti-RANKL antibody, j)Ipriflavone and k)Anabolic hormone
2)Patients diagnosed with rheumatoid arthritis;
3)Patients diagnosed with diabetes (HbA1c>7.6) within 14 days of pre-registration;
4)Patients who has/had suffered from urinary tract stones;
5)Patients who are having tooth extraction or an implant at the time of registration or during a study period;
6)Patients with liver dysfunction (GOT>36IU/L, GPT>36IU/L) within 14 days of pre-registration;
7)Patients with urinary dysfunction (creatinine clearance<35ml/min) within 14 days of pre-registration;
8)Patients with serum calcium level of less than 9.0 or more than of 10.2;
9)Patients with paralysis or a brain degenerative disease;
10)Patients with systemic infection;
11)Patients who cannot take medicine orally;
12)Patients with gastrointestinal disorder that might inhibit the absorption of medicines;
13)patients who are disqualified as sample for this research by principal and co-investigator.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Naomi
Middle name
Last name Kobayashi
Organization Yokohama City University Medical Center
Division name Department of Orthopaedic Surgery
Zip code 2320024
Address 4-57 Urafune-cho, Minami-ku, Yokohama, Japan
TEL 045-261-5656
Email naomik58@aol.com

Public contact
Name of contact person
1st name Taro
Middle name
Last name Tezuka
Organization Yokohama City University
Division name Department of Orthopaedic Surgery
Zip code 2360004
Address Yokohama
TEL +81457872655
Homepage URL
Email tettu59@hotmail.com

Sponsor
Institute Yokohama City University, Orthopaedic Surgery
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 Clinical Research Coordination Department, Center for Novel and Exploratory Clinical Trials
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
Tel +81-45-787-2714
Email nextjim1@yokohama-cu.ac.jp

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 12 Month 26 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 Open public recruiting
Date of protocol fixation
2017 Year 10 Month 20 Day
Date of IRB
2017 Year 11 Month 15 Day
Anticipated trial start date
2018 Year 01 Month 10 Day
Last follow-up date
2020 Year 06 Month 30 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 12 Month 26 Day
Last modified on
2019 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034841

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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