Health Condition 1: M810- Age-related osteoporosis without current pathological fracture
Conditions
Interventions
Intervention1: Group B vitamin K1 supplementation with standard treatment: Alendronate 70 mg once weekly, calcium 500 mg twice daily and vitamin K1 5 mg once daily
Intervention2: Group C vitamin D3 an
Sponsors
King George Medical University
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Postmenopausal women aged 45 to 65 years diagnosed with osteoporosis based on a DEXA scan with a T-score of -2.5 or above. Patient willing to provide written informed consent and available for follow-up during the study period
Exclusion criteria
Exclusion criteria: Subjects with chronic kidney disease stage 4 or stage 5. Subjects with short bowel syndrome or extensive bowel surgery. Subjects receiving glucocorticoid therapy. Subjects with chronic liver disease. Subjects with hypercalcemia. Subjects with rheumatological disorders. Subjects receiving anticoagulant therapy, including warfarin. Subjects treated with bisphosphonates during the previous twelve months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The combination of vitamin K1 and D3 supplementation is expected to enhance osteoblastic activity and reduce bone resorption markers such as CTX and PINP. Timepoint: Baseline and 12-month | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation analysis between BMD, bone turnover markers and inflammatory markers may identify early predictors of treatment response.Timepoint: Baseline and 12-month | — |
Countries
India
Contacts
Public ContactVivek Kumar Verma
King Georges Medical University, Lucknow
Outcome results
None listed