Health Condition 1: M843- Stress fracture
Conditions
Interventions
Intervention1: INJ. ZOLEDRONIC ACID: Tab.Vitamin D3 600 IU per day for 6 months + Inj. Zoledronic acid 4 mg slow IV infusion in 100ml Normal saline in 1 hour OD once at baseline
Control Intervention1:
Sponsors
PT BD SHARMA PGIMS ROHTAK
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TSI MRI grading Verbal rating scale (VRS) scoring Visual analog scale(VAS) scoring Pressure pain test [PPT] Timepoint: TSI MRI grading (at 0 weeks and at end of 4 months) Verbal rating scale (VRS) scoring(at 0 , 2 ,4 and 6 months) Visual analog scale(VAS) scoring(at 0 , 2 ,4 and 6 months) Pressure pain test [PPT]grading(at 0 , 2 ,4 and 6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain disability index (PDI) scoring Timepoint: Pain disability index (PDI) scoring (at 0,2,4 and 6 months) | — |
Countries
India
Contacts
Public ContactDr Chintan Makwana
Pandit BD Sharma PGIMS Rohtak HARYANA
Outcome results
None listed