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Beijing Osteoporosis With Neurological Disorders in Epigenetic Changes Study (BONE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03401619
Recruitment Status : Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : September 17, 2020
Sponsor:
Collaborators:
National Natural Science Foundation of China
Ministry of Education, China
Beijing Municipal Science & Technology Commission
Ministry of Science and Technology of the People´s Republic of China
Peking University Health Science Center
Information provided by (Responsible Party):
Dongwei Fan, Peking University Third Hospital

Study Description
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Brief Summary:
Epigenetic modification refers to the change of heritable gene expression occurring in the case of unchanged DNA sequence, including DNA methylation, epigenetic modification, RNAS, chromatin modification, etc. The study found that osteoporosis (OSTEOPOROSIS,OP) with neurological disorders is very common, the risk of fracture of patients increased. It is considered that epigenetic regulation plays an important role in the occurrence and development of OP with neurological disorders. In particular, the role and molecular mechanism of epigenetic modification in OP with neurological disorders are not clear, and the results of clinical studies with different sample sizes are not consistent. (1) Two-way continuous queues,an ambispective cohort study， namely: forward-looking queue method (2017-2027) and Retrospective queue method (2007-2017) were used to understand the effect of epigenetic modification on bone mineral density, bone metabolic Biochemical Index, imaging index and fracture incidence of patients with neurological diseases in outpatients and wards, and to provide basis for further study. To observe the effects of epigenetic modification on cognitive function in two groups of patients (memory scale, life activity Energy meter (ADL) and cognitive scale (MMSE) and clinical physical examination and neuropsychological test, etc., Bone correlation detection (Lumbar and hip bone mineral density T-score, imaging index, bone Metabolic Biochemical Index and fracture incidence index) Influence. Multivariate stepwise regression analysis was performed to eliminate confounding factors, such as age, body mass index (BMI), related risk factors, and internal diseases. The patient's previous information is also analyzed; (2) To find meaningful epigenetic modification from clinical data, the molecular mechanism was studied in depth, and the imaging indexes (X-ray, CT, MRI) and Bone marker Index (serum osteocalcin (OC), total I-type procollagen peptide (TP1NP) were found in the study. Type I collagen hydroxy-terminated peptide beta degradation product (Β-CTX)). The relationship between the reaction epigenetic modification and cognitive function index, image and bone markers and the mechanism model were further established.

Condition or disease Intervention/treatment
Osteoporosis，Neurological Disorders Combination Product: Exercise，Nutrition，Bisphosphonates，Statins，Calcitonin,Vitamin D，et al.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: Beijing Osteoporosis With Neurological Disorders in Epigenetic Changes Study: an Ambispective, Multicentre, Open Cohort Study
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : September 22, 2026
Estimated Study Completion Date : September 22, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Osteoporosis With Cognitive impairment Combination Product: Exercise，Nutrition，Bisphosphonates，Statins，Calcitonin,Vitamin D，et al.
The long-term effect of comprehensive treatment on health, especially for osteoporosis and neurodegenerative diseases, we hope to find association from epigenetics and provide clues for further exploration of its pathogenesis.
Osteoporosis With Arterial stiffness Combination Product: Exercise，Nutrition，Bisphosphonates，Statins，Calcitonin,Vitamin D，et al.
The long-term effect of comprehensive treatment on health, especially for osteoporosis and neurodegenerative diseases, we hope to find association from epigenetics and provide clues for further exploration of its pathogenesis.
Osteoporosis Combination Product: Exercise，Nutrition，Bisphosphonates，Statins，Calcitonin,Vitamin D，et al.
The long-term effect of comprehensive treatment on health, especially for osteoporosis and neurodegenerative diseases, we hope to find association from epigenetics and provide clues for further exploration of its pathogenesis.
Normal Combination Product: Exercise，Nutrition，Bisphosphonates，Statins，Calcitonin,Vitamin D，et al.
The long-term effect of comprehensive treatment on health, especially for osteoporosis and neurodegenerative diseases, we hope to find association from epigenetics and provide clues for further exploration of its pathogenesis.


Outcome Measures
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Primary Outcome Measures :
  1. cognitive impairment improvement [ Time Frame: year 1,2,3,4 and 5 ]
    Change from baseline in Mild Cognitive Impairment assessment scale-cognitive subscale in year 1,2,3,4 and 5


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Volunteer, outpatient, inpatient
Criteria

Inclusion Criteria:

  • Normal hearing, vision, and pronunciation
  • DEXA examination

Exclusion Criteria:

  • Mental retardation
  • Blindness, deafness, and dumb
  • Severe schizophrenia
Contacts and Locations
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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): NCT03401619


Locations
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China, Beijing
Peking University Third Hospital
Beijing, Beijing, China, 100191
Sponsors and Collaborators
Peking University Third Hospital
National Natural Science Foundation of China
Ministry of Education, China
Beijing Municipal Science & Technology Commission
Ministry of Science and Technology of the People´s Republic of China
Peking University Health Science Center
  Study Documents (Full-Text)

Documents provided by Dongwei Fan, Peking University Third Hospital:
Statistical Analysis Plan  [PDF] September 15, 2020

More Information
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Additional Information:

Publications:

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Responsible Party: Dongwei Fan, Orthopeadic doctor, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03401619    
Other Study ID Numbers: BONEM2017294
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Nervous System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Calcitonin
Salmon calcitonin
 Diphosphonates
Calcitonin Gene-Related Peptide
Katacalcin
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Vasodilator Agents