Health Condition 1: M810- Age-related osteoporosis without current pathological fracture
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Individuals aged above 50 years, of post-menopausal women, with or without a diagnosis of osteoporosis. This includes: o Individuals with a T-score less or equal to -2.5 (osteoporosis) o Individuals with a T-score between -1.0 and -2.5 (osteopenia) o Individuals with normal BMD but having a high, moderate risk after administering Short OPAQ (Osteoporosis Assessment Questionnaire).
Exclusion criteria
Exclusion criteria: Individuals who use bisphosphonates, hormone replacement therapy, daily intake of highdose vitamin D (above 2000 IU/day), corticosteroids and suffering from cancer, renal diseases, congenital musculoskeletal disorders, or unwillingness to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Makhana supplementation is anticipated to improve BMD (bone mineral density), particularly at the lumbar spine, femoral neck, and whole-body composition as measured by DEXA. Improvements in BMD would indicate enhanced bone mass or slowed bone loss, which is critical in both osteoporotic and at-risk populations. Timepoint: baseline at 0 months and endline at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition, improvements in musculoskeletal function, reductions in bone resorption markers (e.g., CTX, NTX, DPD), and increases in bone formation markers (e.g., P1NP, osteocalcin) are expected. Makhana s rich nutrient profile may also contribute to increased serum calcium and vitamin D levels, reduced PTH, and improved overall bone health Timepoint: baseline at 0 months and endline at 6 months | — |
Countries
India
Contacts
ICMR National Institute of Nutrition, Hyderabad