Osteoporosis,Neurological Disorders Clinical Trial
— BONEOfficial title:
Beijing Osteoporosis With Neurological Disorders in Epigenetic Changes Study: an Ambispective, Multicentre, Open Cohort Study
| Verified date | September 2020 |
| Source | Peking University Third Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Active, not recruiting |
| Enrollment | 2000 |
| Est. completion date | September 22, 2027 |
| Est. primary completion date | September 22, 2026 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 55 Years to 105 Years |
| Eligibility |
Inclusion Criteria: - Normal hearing, vision, and pronunciation - DEXA examination Exclusion Criteria: - Mental retardation - Blindness, deafness, and dumb - Severe schizophrenia |
| Country | Name | City | State |
|---|---|---|---|
| China | Peking University Third Hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Peking University Third Hospital | Beijing Municipal Science & Technology Commission, Ministry of Education, China, Ministry of Science and Technology of the People´s Republic of China, National Natural Science Foundation of China, Peking University Health Science Center |
China,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |