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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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18 April 2017 |
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Main ID: |
ChiCTR-TRC-11001313 |
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Date of registration:
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2011-04-29 |
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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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Effect of rhPTH on bone metabolism of Postmenopausal Osteoporosis: a randomized control trial
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Scientific title:
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Effect of rhPTH on bone metabolism of Postmenopausal Osteoporosis: a randomized control trial |
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Date of first enrolment:
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2009-10-01 |
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Target sample size:
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Goup A:89;Group B:35; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=8226 |
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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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Post-market
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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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Gangyi Yang
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Address:
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Department of Endocrinology, the Second Affiliated Hospital, Chongqing Medical University, Chongqing, China
410016
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Telephone:
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+86 023 68485216 |
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Email:
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gangyiyang@yahoo.com.cn |
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Affiliation:
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The Second Affiliated Hospital, Chongqing Medical University |
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Name:
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Gangyi Yang
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Address:
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Department of Endocrinology, the Second Affiliated Hospital, Chongqing Medical University, Chongqing, China
410016
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Telephone:
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+86 023 68485216 |
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Email:
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gangyiyang@yahoo.com.cn |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Postmenopausal wemon of 50 to 75 years old
2. Criteria of osteoporosis in 1994, including one of the following:
1) BMD of lumbar vertebrae =<2.5SD (DEXA method);
2) compression fracture in one of the lumbar vertebrae and T<1.0SD.
Exclusion criteria: 1. Non-primary osteoporosis or bone diseases caused by renal failure, Osteomalacia, etc.
2. Uncontroled diabetes with HbA1c>7% or with other serious complication, other endocrine disease such as hyperthyoidism;
3. Impaired hepatic function with ALT higher than 2 X upper limit of normal;
4. Impaired renal function with serum Cr higher than upper limit of normal;Myocardial infarction, stroke
5. Use other anti osteoporosis drugs within 6 months prior to informed consent.
Age minimum:
50
Age maximum:
75
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Postmenopausal Osteoporosis
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Intervention(s)
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Goup A:rhPTH;Group B:elcatonin ;
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Primary Outcome(s)
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BMD;factors correlated bone metabolism;
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Source(s) of Monetary Support
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the National Natural Science Foundation of China
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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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