Unique ID issued by UMIN | UMIN000030571 |
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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 | 2019/06/28 13:43:33 |
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
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
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
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
Japan |
Patients with hip osteoarthritis or osteonecrosis who are undergoing total hip arthroplasty.
Orthopedics |
Others
NO
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.
Efficacy
Changes in bone mineral density around the femoral implants in 1 year after total hip arthroplasty.
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
2
Treatment
Medicine |
Denosumab is administered by injection along with Eldecalcitol biannually.
Zoledronic acid is administered by injection along with Eldecalcitol once a year.
20 | years-old | <= |
80 | years-old | > |
Male and Female
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.
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.
80
1st name | Naomi |
Middle name | |
Last name | Kobayashi |
Yokohama City University Medical Center
Department of Orthopaedic Surgery
2320024
4-57 Urafune-cho, Minami-ku, Yokohama, Japan
045-261-5656
naomik58@aol.com
1st name | Taro |
Middle name | |
Last name | Tezuka |
Yokohama City University
Department of Orthopaedic Surgery
2360004
Yokohama
+81457872655
tettu59@hotmail.com
Yokohama City University, Orthopaedic Surgery
Yokohama City University
Other
Clinical Research Coordination Department, Center for Novel and Exploratory Clinical Trials
3-9 Fukuura, Kanazawa-ku, Yokohama
+81-45-787-2714
nextjim1@yokohama-cu.ac.jp
NO
2017 | Year | 12 | Month | 26 | Day |
Unpublished
Open public recruiting
2017 | Year | 10 | Month | 20 | Day |
2017 | Year | 11 | Month | 15 | Day |
2018 | Year | 01 | Month | 10 | Day |
2020 | Year | 06 | Month | 30 | Day |
2017 | Year | 12 | Month | 26 | Day |
2019 | Year | 06 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034841
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