Beijing Osteoporosis With Neurological Disorders in Epigenetic Changes Study

NCT03401619 | Active Not Recruiting DMC

• 1 other identifier: BONEM2017294
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis，Neurological Disorders

Outcome Measures

Primary Outcomes (1)

• cognitive impairment improvement

  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

Study Arms (4)

Osteoporosis With Cognitive impairment

Combination Product: Exercise，Nutrition，Bisphosphonates，Statins，Calcitonin,Vitamin D，et al.

Osteoporosis With Arterial stiffness

Combination Product: Exercise，Nutrition，Bisphosphonates，Statins，Calcitonin,Vitamin D，et al.

Osteoporosis

Combination Product: Exercise，Nutrition，Bisphosphonates，Statins，Calcitonin,Vitamin D，et al.

Normal

Combination Product: Exercise，Nutrition，Bisphosphonates，Statins，Calcitonin,Vitamin D，et al.

Interventions

Exercise，Nutrition，Bisphosphonates，Statins，Calcitonin,Vitamin D，et al. COMBINATION_PRODUCT

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; Osteoporosis; Osteoporosis With Arterial stiffness; Osteoporosis With Cognitive impairment

Eligibility Criteria

• Age: 55 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteer, outpatient, inpatient

You may qualify if:

• Normal hearing, vision, and pronunciation
• DEXA examination

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (8)

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  PMID: 26144908 BACKGROUND

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  PMID: 25456365 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopeadic doctor

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 17, 2018
• Study Start: September 21, 2017
• Primary Completion (Estimated): September 22, 2026
• Study Completion (Estimated): September 22, 2027
• Last Updated: September 17, 2020

Record last verified: 2020-09

Locations

CN (1)