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临床试验/CTRI/2025/12/099057
CTRI/2025/12/099057尚未招募不适用

STUDY EFFECT OF ZOLENDRONIC ACID VS DENOSUMAB ON BACK PAIN IN PATIENTS WITH OSTEOPOROSIS IN TERTIARY CARE CENTRE -RANDOMIZED CONTROLLED STUDY

school of medical sciences and research Sharda university1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2026年1月1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
56
试验地点
1
主要终点
To compare the reduction in low back pain intensity (measured using the Visual Analog Scale [VAS]) over a 6-month period between patients receiving zoledronic acid and those receiving denosumab.

研究概览

简要总结

This randomized controlled trial aims to compare the efficacy of Zoledronic Acid and Denosumab in reducing chronic low back pain among patients with osteoporosis at a tertiary care center. Osteoporosis leads to reduced bone mineral density and chronic pain, especially in postmenopausal women. Both Zoledronic Acid and Denosumab are established anti-resorptive agents but act through different mechanisms. This study will evaluate changes in pain intensity using the Visual Analog Scale (VAS) and bone mineral density (BMD) at the lumbar spine using DEXA scans over six months. Fifty-six patients aged 50 years and above with diagnosed osteoporosis will be randomized into two groups: one receiving Zoledronic Acid 5 mg IV yearly and the other Denosumab 60 mg subcutaneously every six months, along with calcium and vitamin D supplementation. The findings will help determine which agent provides better pain relief and improvement in bone health, aiding clinical decision-making in osteoporosis management.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

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

入选标准

  • Age MORE THAN AND EQUAL TO 50 years Patient of any gender diagnosed with osteoporosis (T-score LESS THAN -2.5 on DEXA) Chronic low back pain (MORE THAN 3 months) VAS MORE THAN 4 Pain not relieved by NSAIDs AND opiods and physiotherapy.

排除标准

  • Prior use of bisphosphonates or denosumab in the last 12 months History of malignancy and metabolic bone disease (other than osteoporosis) Patients with traumatic fractures of the spine Patients on long term glucocorticoid therapy Any other cause of lower back ache.

结局指标

主要结局

To compare the reduction in low back pain intensity (measured using the Visual Analog Scale [VAS]) over a 6-month period between patients receiving zoledronic acid and those receiving denosumab.

时间窗: 0 , 3 AND 6 MONTHS

次要结局

未报告次要终点

研究者

发起方
school of medical sciences and research Sharda university
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

anmol kakkar

school of medical sciences and research sharda university

研究点 (1)

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