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临床试验/NCT05103592
NCT05103592Unknown不适用

Assessment of Tartrate- Resistant Acid Posphatase 5b (TRACP-5b) in Primary and Secondary Osteoprosis

Assiut University0 个研究点目标入组 84 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
84
主要终点
Assessment of the TRACP-5b level in 1ry OP and 2ry OP such as RA and seronegative, that may help in surrogating the use of BMD.

研究概览

简要总结

Assessment of the TRACP-5b level in 1ry OP and 2ry OP such as RA and seronegative spondylitis, that may help in surrogating the use of BMD.

详细描述

Osteoporosis is a disease characterized by low bone density and a deterioration of bone microarchitecture that reduces bone strength and increases the risk of fracture. The hallmark of osteoporosis is the loss of both bone mineral and bone matrix. Although Bone mass density (BMD) is still the gold standard for the diagnosis of osteoporosis, but bone turnover markers (BTMs) can provide helpful information regarding the bone remodelling process. One of these relatively recent markers is the Tartrate-resistant acid phosphatase (TRACP). TRACP, which was first identified in human leukocytes, has 2 isoforms TRAP-5a derived from macrophages and dendritic cells and TRACP-5b secreted by osteoclasts. it is believed that TRACP-5b is a useful marker of osteoclast activity, even a marker for osteoclast number, as it is associated with osteoclast differentiation, activation and proliferation. Furthermore, it has the advantage of not being affected by renal dysfunction, nor food intake and has a weak diurnal variability. And this is why it has been used as one of the bone turnover markers in evaluating the efficacy of different anti-resorptive treatments in postmenopausal osteoporosis and in 2ry OP due to rheumatoid arthritis as well as in evaluating its specificity in identification of postmenopausal OP when compared to measurement of more expensive, relatively unavailable bone mineral density (BMD).So far, limited researches are available regarding the TRACP-5b level difference among 1ry OP (postmenopausal women) and 2ry OP (ex. RA, SpA).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Patients with 1ry OP diagnosed by DXA scan .
  • Any RA and SpA patients (older than 18 years old), who fulfill the for mentioned diseases criteria with secondary osteoporosis as diagnosed by DXA scan.

排除标准

  • Patients unwilling to participate in the study.
  • Patients with other autoimmune diseases.
  • Patients depending on Glucocorticoids with in the last 6 month.
  • Patients with other causes of 2ry OP (ex. Endocrinal abnormalities, Gastrointestinal diseases, Renal diseases.....etc.)

结局指标

主要结局

Assessment of the TRACP-5b level in 1ry OP and 2ry OP such as RA and seronegative, that may help in surrogating the use of BMD.

时间窗: Baseline

Assessing Tartrate- resistant Acid Phosphatase Marker in primary osteoporosis, rheumatoid arthritis, ankylosing spondylitis and control group that may help in substituting Dxa scan.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amira Mohammad Abdalmageed Mansour

resident doctor at Rheumatology and Rehabilitation department

Assiut University

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