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临床试验/CTRI/2024/05/067474
CTRI/2024/05/067474尚未招募不适用

Evaluation of Disease and Treatment Awareness, Self Medication Practices and Prescription Patterns in Patients of Osteoporosis Attending a Tertiary Care Hospital: A Cross-sectional, Questionnaire-based Study.

Dr Raakhi Tripathi1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年5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
600
试验地点
1
主要终点
1. The primary variable is percentage of patients stating yes for each item of the Disease

研究概览

简要总结

Osteoporosis is a condition characterized by low bone mass and micro-architectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Since the disease is chronic and the course of treatment spans from over 6 months to lifelong, adherence to drug therapy is an important factor to prevent deterioration of the disease. . Adherence to osteoporosis medications is relatively poor. The clinical benefit from osteoporosis therapies has a clear association with medication adherence.Treatment Awareness of the patient will help to improve the adherence of patients to Osteoporosis Medication. There have been no studies in India on Treatment Awareness of Osteoporosis. The study will focus on Assessing Treatment Awareness of Osteoporosis Patients. There have been only a few studies in the Western part of India to evaluate the awareness of Osteoporosis in patients hence, the study also aims to evaluate the Awareness of Osteoporosis in patients of Osteoporosis. 

Osteoporosis, being a chronic condition, apart from the issue of adherence and poor drug treatment awareness, being a chronic disorder, patient’s resort to self medications. Studies to date suggest that people with chronic conditions are more likely to use CAM (complementary and alternative medicine). Thus, this study will also focus on Self Medication practices in Osteoporosis.

The treatment for osteoporosis consists of Non-Pharmacological interventions such as prescribing exercise, weight-bearing physical activity and exercises that improve balance and posture, a diet rich in vitamin D and calcium, quitting smoking, and limiting alcohol use. Specific medication prescriptions are necessary. The Pharmacotherapy of Osteoporosis consists of prescribing drugs which are classified into two groups: those that decrease bone resorption (antiresorptive agents) and those that increase skeletal formation (anabolic agents). Antiresorptive drugs (bisphosphonates [BPs], denosumab, estrogen replacement therapy [ERT], and selective estrogen receptor modulator [SERM]) reduce the rate of bone resorption. Anabolic drugs (teriparatide, romosozumab) stimulate bone formation and partially bone resorption. Since a wide range of treatment options are available for Management of Osteoporosis, hence variability within the prescription pattern is seen. There are very few studies to evaluate prescription pattern. This study aims to evaluate prescription patterns in patients of Osteoporosis.

Primary Objective:

  1. To evaluate the Disease and Treatment Awareness in patients of Osteoporosis with or without comorbidities coming to Endocrinology OPD and Orthopaedic OPD using a Pre-validated Disease and Treatment Awareness Questionnaire.

 Secondary Objectives:

1.     To assess the Self Medication Practices in Patients of Osteoporosis with or without comorbidities using Pre-validated Self Medication Questionnaire.

2.     To evaluate the Prescription Pattern of drugs used in the treatment of patients with Osteoporosis with or without comorbidities.

Sample Size: Total of 600 patients attending Endocrinology OPD and Orthopaedic OPD, meeting the inclusion/ exclusion criteria during the study period shall be enrolled. Sample size is in accordance as per WHO guidelines for Good Prescribing Patterns in Health studies.

Primary and Secondary Variables shall be measured. Statistical Analysis will be done.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • attending Endocrinology OPD and Orthopaedic OPD and have already been receiving treatment for at least 1 month with confirmed diagnosis of Osteoporosis with or without comorbidities by treating physician.

排除标准

  • Patients not willing to give informed consent
  • Patients admitted in IPD and emergency department
  • Newly diagnosed and treatment naive patients.

结局指标

主要结局

1. The primary variable is percentage of patients stating yes for each item of the Disease

时间窗: As this is a cross-sectional survey, outcomes will be assessed at end of study,i.e, 18 months.

and Treatment awareness questionnaire.

时间窗: As this is a cross-sectional survey, outcomes will be assessed at end of study,i.e, 18 months.

2. Mean awareness score will be calculated

时间窗: As this is a cross-sectional survey, outcomes will be assessed at end of study,i.e, 18 months.

3. Mean Awareness Score will be correlated with demographic factors (Age, gender,

时间窗: As this is a cross-sectional survey, outcomes will be assessed at end of study,i.e, 18 months.

occupation, education, and socio-economic status as per Kuppuswamy scale).

时间窗: As this is a cross-sectional survey, outcomes will be assessed at end of study,i.e, 18 months.

次要结局

  • Percentage of patients of Osteoporosis with or without(comorbidities stating yes for each item of the self medication practice questionnaire using descriptive statistics)
  • To study the pattern of drugs used in the treatment of Osteoporosis .(As this is a cross-sectional survey, outcomes will be assessed at end of study,i.e, 18 months.)

研究者

发起方
Dr Raakhi Tripathi
申办方类型
Other [Associate Professor, PG Guide & Principal investigator]
责任方
Principal Investigator
主要研究者

Dr Raakhi K Tripathi

Seth GS Medical College and KEM Hospital

研究点 (1)

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