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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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5 November 2018 |
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Main ID: |
ChiCTR1800019277 |
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Date of registration:
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2018-11-02 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Zoledronic Acidameliorate theSecondary Osteoporosis in Rheumatoid Arthritis patients
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Scientific title:
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The Zoledronic Acidameliorate theSecondary Osteoporosis in Rheumatoid Arthritis patients |
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Date of first enrolment:
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2018-11-01 |
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Target sample size:
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Control group:22;Treatment group 1:22;Treatment group 2:22; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=32545 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Other
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Countries of recruitment
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China
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Contacts
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Name:
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Xie Jun
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Address:
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540 Xinhua Road, Shanghai, China
200052
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Telephone:
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+86 13661941356 |
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Email:
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leoxie199@126.com |
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Affiliation:
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Shanghai Traditional Medicine University Affiliated Guanghua Hospital |
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Name:
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Xiao Lianbo
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Address:
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540 Xinhua Road, Shanghai, China
200052
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Telephone:
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+86 021 62805833 |
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Email:
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xiaolianbo199@126.com |
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Affiliation:
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Shanghai Traditional Medicine University Affiliated Guanghua Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: The consent to participation was obtained from patients who were clearly diagnosed as rheumatoid arthritis andeither:
1) L1-L4 or hip T value =-2.5 in BMD measurement plus obvious low back pain, night convulsions and limited life function symptoms, or
2) L1-L4 or hip joint T value = -1.5, = -2.5 in BMD measurement plus obvious low back pain, night convulsions and limited life function symptoms, with previous one or more fracture history.
Exclusion criteria: (1) severe primary diseases in cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, consumptive chronic diseases, or mental illness;
(2) hypercalcemia, fresh fractures, liver or kidney dysfunction, thyroid-related diseases (such as hypothyroidism, hyperthyroidism), or malignant tumors;
(3) other joint-involving rheumatic diseases, such as systemic lupus erythematosus, dermatomyositis, Sjogren's syndrome, ankylosing spondylitis, gout, etc;
(4) allergy to the test drug zoledronate, or history of other allergies;
(5) pregnancy, breastfeeding, or planning to become pregnant in the near future;
(6) currently participating in other clinical trials.
Age minimum:
18
Age maximum:
65
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Control group:MTX;Treatment group 1:Zoledronate Acid(ZA);Treatment group 2:MTX+Zoledronate Acid;
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Primary Outcome(s)
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CRP;ESR;BMD;
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Secondary Outcome(s)
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Morning time;Patient and doctor evaluation;
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Source(s) of Monetary Support
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Shanghai Science and Technology Commission
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Ethics review
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Status: Approved
Approval date: 26/08/2013
Contact:
Li Dan
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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