跳至主要内容
临床试验/CTRI/2025/08/093788
CTRI/2025/08/093788尚未招募不适用

Reconfiguration of management of osteoporosis in children and adults a shift in paradigm from treatment to prevention using a novel biotechnology device Swastya for Asthi Tavasya

Department of BiotechnologyDBT1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2025年9月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,500
试验地点
1
主要终点
Cortical sound velocity from newly developed device

研究概览

简要总结

The objective  of the current mixed method study is :

1.To develop  a novel, portable, non-invasive, handheld device to estimate fracture risk by measuring bone mineral density at the radial styloid bone using cortical sound velocity as an outcome measure.

  1. To study bone mineral density in-vitro and non-invasive measurement of bone cortical sound velocity in human radius bone

  2. To study the reliability and validity of the device in healthy adults.

  3. To establish a reference band of waveform (produced based on cortical bone sound velocity) ranging from healthy to osteoporotic bone density for screening people with osteoporosis.

To achieve the above objective the novel device will be first developed with ensuring all safety guidelines and tested in cadaveric bones of different porosity. Then will be pilot tested with novel device and DEXA scan for bone mineral density in 1500 healthy children and adults in the age a group of 7- 15 years and 18 to 70 years. With the study finding association between cortical

bone sound velocity and bone mineral density will be found.

研究设计

研究类型
Observational

入排标准

年龄范围
7.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Healthy children 7 to 15 years Healthy adults elderly individual 40 to 70 years.

排除标准

  • Individuals with grade 3 and 4 severe osteoarthritis low back pain with VAS more than 5 neurological deficit stroke diabetes or hypertension congenital or acquired bony deformities of lower extremities and spine and those having cognitive issues will be excluded.

结局指标

主要结局

Cortical sound velocity from newly developed device

时间窗: Baseline

Bone mineral density measured using DEXA

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
Department of BiotechnologyDBT
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Rajani Mullerpatan

MGM School of Physiotherapy MGM Institute of Health Sciences

研究点 (1)

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