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

September 15, 2020 updated by: Dongwei Fan, Peking University Third Hospital

Beijing Osteoporosis With Neurological Disorders in Epigenetic Changes Study: an Ambispective, Multicentre, Open Cohort Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 105 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Volunteer, outpatient, inpatient

Description

Inclusion Criteria:

  • Normal hearing, vision, and pronunciation
  • DEXA examination

Exclusion Criteria:

  • Mental retardation
  • Blindness, deafness, and dumb
  • Severe schizophrenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
year 1,2,3,4 and 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Collaborators

National Natural Science Foundation of China
Ministry of Science and Technology of the People´s Republic of China
Beijing Municipal Science & Technology Commission
Peking University Health Science Center
Ministry of Education, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2017

Primary Completion (Anticipated)

September 22, 2026

Study Completion (Anticipated)

September 22, 2027

Study Registration Dates

First Submitted

January 3, 2018

First Submitted That Met QC Criteria

January 9, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BONEM2017294

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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