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临床试验/CTRI/2024/12/078375
CTRI/2024/12/078375尚未招募4 期

Treating osteoporosis with yoga: Indias first clinical trial

Ravi Sankaran1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月30日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
DEXA scan

研究概览

简要总结

Background:

More than 10,000,000 Americans have osteoporosis; mor than 44 million have osteopenia.  These 54,000,000 people were found in a country of 330,000,000 people, approximately  1/6 of the population.  Extrapolating to the 8,000,000,000 people on our planet, and acknowledging the older and younger populations in Europe and China, and the younger average age in Africa, we may conclude that 1/6 of the world’s population: more than one billion people are affected by weakened bones.

Although vertebral fractures are by far the most frequent, occurring at the rate of every three seconds, hip fractures are the most serious.  Fully 25% of people with these fractures will perish, and another 25% will be permanently chair-bound. The pain and subsequent disability after hip and femoral fractures is well-known.

Since the population of the world is aging, a worsening of the epidemiology here is nearly certain.  A safe and inexpensive way to deal effectively with bone loss will relieve this serious public health issue.  The following study, if successful, will do just that.

Objective:

To determine the extent to which basic nutritional supplementation and brief yoga sessions can reverse bone loss.

Methods:

The study will calculate changes in DEXA scan measurements from before starting the study to those seen at study entry, and compare them with changes in DEXA scan measurements made after two years in the study.  The rate of change of bone mineral density (BMD) in the one or more years preceding study entry will be compared with the rate of change in BMD in the two years of study participation. The study will track both intervention and control patient with an on-line database that participants fill out weekly.

Each patient will first be randomized using random.org, and then will give a full history and have a selective physical exam, by a physician who does not know their randomized group.  The participant will then be taught the appropriate yogic modality, given a 3-months’ dose of the appropriate tablets/capsule or placebo, and a log on for the on-line database.

Weekly classes for yoga will be given and attendance and level of participation noted.

Tri monthly visits to the endocrinologist or physiatrist are in order.

Statistics will involve t-tests, MANCOVA, and Bayesian methods.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

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

入选标准

  • DEXA scan at least one year prior to entry.
  • Normal serum values of: TSH PTH CMP ESR or CRP Vitamin D 25 Hydroxyl Vitamin D 1,25 Dihydroxyl Serum Collagen 1B telopeptide or Urine NTX.

排除标准

  • Neuromuscular, metabolic or endocrinological abnormalities, e.g., Guillaine-Barre, diabetes mellitus, Graves disease, cancer.
  • Physical disability preventing yoga practice.

结局指标

主要结局

DEXA scan

时间窗: 0 and at 24 months

次要结局

  • Compliance to medications and yoga interventions(0 and at 24 months)

研究者

发起方
Ravi Sankaran
申办方类型
Other [n/a]
责任方
Principal Investigator
主要研究者

Ravi Sankaran

Amrita Hospital Kochi

研究点 (1)

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