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

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ClinicalTrials.gov Identifier: NCT03401619
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
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

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 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

Drug Information available for: Calcitonin

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.




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



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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
  • patients with multiple myeloma, bone metastases ,et al.

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


Contacts
Contact: Dongwei Fan, doctor 861013522421109 fdw@bjmu.edu.cn

Locations
China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Zhongqiang Chen, doctor    861082265557    chenzq@bjmu.edu.cn   
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

Publications:

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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Osteoporosis
Nervous System Diseases
Pathologic Processes
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Diphosphonates
Calcitonin
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents