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Beijing Osteoporosis With Neurological Disorders in Epigenetic Changes Study

Study acronym: BONE
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 30 days later Sep 22, 2026 → Oct 22, 2026
See other at-risk trials from Peking University Third Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion pushed from Sep 22, 2026 to Oct 22, 2026
    • Collaborators: details revised at 1 of 5 entries
    • Publications: details revised at 8 of 8 entries
    • Eligibility criteria expanded, about 5 words
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Eligibility criteria shortened, about 8 words
    • Site details revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03401619
Lead Sponsor Peking University Third Hospital
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
Conditions
(from sponsor)
Osteoporosis,Neurological Disorders
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov