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CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome (PMOP)

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ClinicalTrials.gov Identifier: NCT02981732
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
xuhuijuan, Fujian Academy of Traditional Chinese Medicine

Brief Summary:
For nearly 112 million patients with osteoporosis in China, it is of great significance for preventing and treating by clearly understanding the molecular mechanism of kidney deficiency. Thus, the research group has demonstrated in the earlier research that CLCF1 is an associated gene that can regulate JAK2/STAT3 signal pathway and impact bone metabolism for kidney yin deficiency of postmenopausal osteoporosis (PMOP). To make clear understanding of the direct-acting mechanism of CLCF1 for bone metabolism, this study intends to: ①observe impacts of low expression of CLCF1 upon immunities in mice and OPG/RANKL/RANK signal system using the technology of adenovirus associated virus. ②explore impacts of over-expression and silencing of CLCF1 on B lymphocytes by culcuturing the cells together with osteoblasts. ③ analyze the impacts of treating kidney yin deficiency of PMOP by Liuwei Dihuang pill upon immunities and OPG/RANKL/RANK system, and discuss the mechanism of regulating bone metabolism by CLCF1 by OPG/RANKL/RANK system via the bridge between immune system and bone metabolism, so as to demonstrate if the hypothesis of this study that "the molecular osteoimmunological mechanism of kidney yin deficiency of postmenopausal osteoporosis (PMOP) is possibly closely related to the impacts of CLCF1 regulation of OPG/RANKL/RANK signal system on bone metabolism" is right or not.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Other: Liuwei Dihuang Pill Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome Regulating the Bone Osteoimmunology Mechanism by the OPG/RANKL/RANK Signal System
Study Start Date : October 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Shen (Kidney) yin deficiency
Shen (Kidney) yin deficiency
Other: Liuwei Dihuang Pill
No Intervention: the control group
the control group,there is no intervention



Primary Outcome Measures :
  1. osteoporosis treatment within six months of study enrollment [ Time Frame: Liuwei Dihuang Pills therapy(up to six months) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   46 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients were included if they were female Han Chinese patients who had undergone natural menopause at least 2 years prior and

    • met the diagnostic criteria for osteoporosis according to the "clinical practice guidelines of traditional medicine for primary osteoporosis"
    • met the CM diagnostic criteria according to "Syndrome Differentiation in Modern Research of Traditional Chinese Medicine"
    • provided informed consent, which was approved by the Fujian Academy of Traditional Chinese Medicine Clinical Research Ethics Committee

Exclusion Criteria:

  • patients who did not meet the diagnostic criteria for osteoporosis or CM standards
  • patients with rheumatoid arthritis, diabetes, secondary osteoporosis due to hyperthyroidism, and severe cardiovascular or cerebrovascular diseases
  • patients with abnormal liver and/or Shen function test results
  • patients with osteoporosis who had received treatment with CM within the last month, hormone replacement therapy and calcitonin within the past three months, or bisphosphonates for 15 consecutive days within the past 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981732


Contacts
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Contact: Yao xin 0591-83570813 yjyllbgs@163.com

Locations
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China, Fujian
Fujian Academy of Trational Chiness Medicine Recruiting
Fuzhou, Fujian, China, 350003
Contact: Yao xin    0591-83570813    yjyllbgs@163.com   
Sponsors and Collaborators
xuhuijuan

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Responsible Party: xuhuijuan, Fujian Academy of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02981732     History of Changes
Other Study ID Numbers: 81674007
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017

Keywords provided by xuhuijuan, Fujian Academy of Traditional Chinese Medicine:
Osteoporosis
kidney yin deficiency syndrome
liuwei dihuang pill

Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Yin Deficiency
Pathologic Processes
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases