To find out effect and safety of drug Zoledronic acid as an add on treatment to vitamin D in patients having stress fractures in bones of both the legs.
- Conditions
- Health Condition 1: M843- Stress fracture
- Registration Number
- CTRI/2023/02/050079
- Lead Sponsor
- PT BD SHARMA PGIMS ROHTAK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1-patients between 18 to 45 years of age.
2- patients newly diagnosed as having stress fracture.
3- patients having MRI evidence of stress fracture as per TSI grading 1 to 2.
4- patients willing to give written informed consent.
5- patients with low level of vitamin d3 then normal.
1. MRI grade 3 and 4 for stress fracture as per TSI grading.
2. Patients who have received any intraarticular injection of zoledronic acid at least 3 months before the study.
3. Patients with known hypersensitivity to study drugs.
4. Patients with severe renal insufficiency or hepatic disease.
5. Pregnant females.
6. Patients who refused to give informed consent.
7. Patients older than 45 years of age
8. Patients with osteoporosis
9. Patients with pathological fractures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TSI MRI grading <br/ ><br> <br/ ><br>Verbal rating scale (VRS) scoring <br/ ><br> <br/ ><br>Visual analog scale(VAS) scoring <br/ ><br> <br/ ><br>Pressure pain test [PPT] <br/ ><br>Timepoint: <br/ ><br>TSI MRI grading (at 0 weeks and at end of 4 months) <br/ ><br> <br/ ><br>Verbal rating scale (VRS) scoring(at 0 , 2 ,4 and 6 months) <br/ ><br> <br/ ><br>Visual analog scale(VAS) scoring(at 0 , 2 ,4 and 6 months) <br/ ><br> <br/ ><br>Pressure pain test [PPT]grading(at 0 , 2 ,4 and 6 months) <br/ ><br>
- Secondary Outcome Measures
Name Time Method Pain disability index (PDI) scoring <br/ ><br>Timepoint: Pain disability index (PDI) scoring (at 0,2,4 and 6 months) <br/ ><br>
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