UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030571 |
|---|---|
| Receipt number | 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 | 2024/07/18 09:19:25 |
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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
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
tettu59@hotmail.com
Sponsor or person
Institute
Yokohama City University, Orthopaedic Surgery
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
Clinical Research Coordination Department, Center for Novel and Exploratory Clinical Trials
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
+81-45-787-2714
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
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
28
Results
In zone 1, denosumab significantly reduced periprosthetic bone mineral density loss compared to zoledoronic acid. As for zone 7, however, denosumab and zoledronic acid showed similar effects on bone mineral density loss.
Results date posted
| 2024 | Year | 07 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patient background of the denosumab and zoledronic acid groups is shown below.
Number of patients 12/10, female:male 11:1/10:0, mean age (years) 68.7/68, BMI (kg/m2)24.4/26, OA: ONFH 12:0/10:0, JOA score 48.8/48, Harris Hip Score 58/53, lumbar spine bone density frontal image (g/cm2)0.94/ 0.92, Lateral image of lumbar spine bone density (g/cm2)0.59/0.57.
Participant flow
Participants who are scheduled to undergo total hip arthroplasty and meet the selection criteria will receive an explanation from their treating physician, and if they agree, they will be randomly assigned to either the denosumab or zoledronic acid group by simple randomization after eligibility confirmation. In the denosumab group, the drug is administered once every 6 months, and in the zoledronic acid group, the drug is administered once a year. Both groups are also to take eldecalcitol once daily. Participants will undergo peri-implant bone density testing at 1 week, 6 months, and 1 year after total hip arthroplasty. Clinical evaluations will be conducted at six months and one year postoperatively. Adverse drug events will also be investigated.
Adverse events
No apparent adverse events were observed in the participants.
Outcome measures
The primary endpoints were changes in bone mineral density around the femoral implant and adverse events at 1 year after total hip arthroplasty. Secondary endpoints were changes in bone mineral density around the femoral implant and clinical and functional assessments at 1 week, 6 months, and 1 year after total hip arthroplasty.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
The reason the protocol and results were not published was due to a change in the person in charge at the time and the fact that the target number of patients could not be reached and a sufficient number of cases could not be collected for analysis.
Management information
Registered date
| 2017 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034841
