NCT03401619: BONE

Beijing Osteoporosis With Neurological Disorders in Epigenetic Changes Study

Active, enrolled Last updated 17 September 2020

What this trial tests

trial testing Exercise，Nutrition，Bisphosphonates，Statins，Calcitonin,Vitamin D，et al. in Osteoporosis，Neurological Disorders in 2,000 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 September 2017

Primary endpoint
22 September 2026

22 September 2027

Quick facts

Lead sponsor	Peking University Third Hospital
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	2,000
Start date	21 September 2017
Primary completion	22 September 2026
Estimated completion	22 September 2027
Sites	1 location across China

Drugs / interventions tested

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

Conditions studied

• Osteoporosis，Neurological Disorders — all drugs for Osteoporosis，Neurological Disorders →

Sponsor

Peking University Third Hospital

Who can join

Adults 55 to 105, any sex, with Osteoporosis，Neurological Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Proximity to major roads and the incidence of osteoporotic fractures in elderly women: The BONE study in Beijing.
   Ren Y, Li W, Chen Z, Liu J, et al · · 2022 · cited 3× · PMID 36530693 · DOI 10.3389/fpubh.2022.1036534