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临床试验/NCT05732870
NCT05732870招募中不适用

OSTEOMICS: Identifying Regulators of Bone Homeostasis

Relation Therapeutics8 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2023年1月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
8
主要终点
Acquisition of bone waste

研究概览

简要总结

Diseases of bone associated with ageing, including osteoporosis (OP) and osteoarthritis (OA), reduce bone mass, bone strength and joint integrity. Current non-surgical approaches are limited to pharmaceutical agents that are not disease modifying and have poor patient tolerability due to side effect profiles. Developing a fundamental understanding of cellular bone homeostasis, including how key cell types affect tissue health, and offering novel therapeutic targets for prevention of bone disease is therefore essential. This is the focus of OSTEOMICS.

A number of factors have been linked to increased risk of bone disease, including genetic predisposition, diet, smoking, ageing, autoimmune disorders and endocrine disorders. In our study, we will recruit patients undergoing elective and non-elective orthopaedic surgery and obtain surgical bone waste for analysis. This will capture a cohort of patients with bone disorders like OP and OA, in addition to patients without overt clinical bone disease. We will study the relationship between the molecular biology of bone cells, bone structure, genetics (DNA) and environmental factors with the aim of identifying and validating novel therapeutic targets.

We will leverage modern single cell technologies to understand the diversity of cell types found in bone. These technologies have now led to the characterisation of virtually every tissue in the body, however bone and bone-adjacent tissues are massively underrepresented due to the anatomical location and underlying technical challenges. Early protocols to demineralise bone and perform single cell profiling have now been developed. We will systematically scale up these efforts to observe how genetic variation at the population level leads to alterations in bone structure and quality.

Over the next 10 years, we will generate data to comprehensively characterise bone across health and disease, use machine learning to drive analysis, and experimentally validate hypotheses - which will ultimately contribute to developing the next generation of therapeutic agents.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with osteoarthritis undergoing total joint arthroplasty, osteotomy or arthrodesis of any joint (including hip, knee, shoulder, wrist, elbow, ankle).
  • Patient with fractured neck of femurs undergoing hemiarthroplasty or total hip arthroplasty, or other internal fixation procedure.
  • Patients undergoing acute low-velocity or fragility fracture fixation surgery.
  • Patients aged between 18-110 years old with capacity to consent.
  • Since deteriorating bone health including diseases like osteoporosis are primarily conditions of older age there is no practical upper age-limit. However, study involvement is limited by suitability for surgery which encompasses multiple factors considered on an individual case basis including age, frailty, comorbidities, baseline mobility, renal function and ability to consent (for instance due to dementia or delirium).
  • We note that our inclusion criteria is purposefully broad as we aim to deduce trends across a wide range of conditions and backgrounds.

排除标准

  • Patients unable to provide informed consent.
  • Patients with suspected/established underlying malignancy.
  • Patients with suspected/established osteomyelitis.
  • Patients with suspected/established bloodborne disease
  • Patients who are currently a subject of a clinical trial involving an investigational medicinal product.

研究组 & 干预措施

Participant undergoing orthopaedic surgery

  • Patients with osteoarthritis undergoing total joint arthroplasty, osteotomy or arthrodesis of any joint (including hip, knee, shoulder, elbow, ankle).
  • Patients with fractured neck of femurs undergoing hemiarthroplasty or total hip arthroplasty, or other internal fixation procedure.
  • Patients undergoing acute low-velocity or fragility fracture fixation surgery.

干预措施: Relevant orthopaedic surgery (Procedure)

结局指标

主要结局

Acquisition of bone waste

时间窗: Within 4 hours of resection.

Discarded bone waste to be used for the study of RNA.

次要结局

  • Acquisition of 10ml of blood.(Within 4 hours of resection.)
  • Completion of participant questionnaire(EDC entry within 1 week of surgery.)

研究者

发起方
Relation Therapeutics
申办方类型
Industry
责任方
Sponsor

研究点 (8)

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