Health Condition 1: M80-M85- Disorders of bone density and structure
Conditions
Interventions
Intervention1: High dose vitamin D: The treatment group will receive the same regimen as the control group, along with daily high-dose vitamin D of 60,000IU supplementation for initial 5 days as a co
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: 1.All patients who had given consent for the study. 2.Patients of age between more than 50 years with osteoporosis (T score less than -2.5 SD) as determined by DEXA scan. 3.Patients with normal Sr Creatinine, Sr Calcium, Sr Phosphate, Sr Alkaline Phosphatase.
Exclusion criteria
Exclusion criteria: 1. Secondary osteoporosis due to utilization of drugs like phenytoin, warfarin, corticosteroids etc and disuse osteoporosis due to deformity or stiffness or patients with endocrinological disorders causing osteoporosis. 2. Patients with abnormally high Sr Parathyroid levels with hypercalcemia ( primary hyperparathyroidism causes - secondary osteoporosis) 3. Subjects with vitamin D level more than 30ng/dL. 4. HIV patients using ART. 5. Patients with active tuberculosis or patients on anti-tubercular treatment. 6. Renal Failure patients on dialysis or post transplantation or patients with high serum creatinine. 7. Subjects with history of nephrolithiasis, urolithiasis. 8. Elderly women using hormone replacement therapy. 9. Elderly men using testosterone inhibitors for BPH. 10. Patients with sarcoidosis or malignancies or chemotherapy. 11. Alcoholic liver disease or any other significant liver disease with elevated enzymes. 12. Malabsorption syndromes. 13. Rheumatological disorders on DMARDs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in T-score on DEXA scan of right hip from baseline to 6 months. Change in serum 25-hydroxy Vitamin D levels from baseline to 6 months. Proportion of patients achieving Vitamin D sufficiency at 6 months.Timepoint: Baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactS Kavin Balaji
AIIMS
Outcome results
None listed