Health Condition 1: M810- Age-related osteoporosis without current pathological fracture
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria : Women aged 50 - 65 years, Menopausal at least since 5 years Diagnosed as osteoporosis at femur or lumbar spine using DXA Normal ECG findings Cognitive, able to do their day to day activities, Not willing to take antiresorptive medicines Physically able to participate in the study for 2 years duration, Willing to undergo dietary modifications and maintain log of the same Willing to undergo exercise along with yoga on daily basis and under supervision on weekly basis Undergone the 3-month exercise and yoga course at the community hall Staying nearby and willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: Women with systemic diseases like cardiac, cancer and other debilitating diseases, or with secondary osteoporosis Undergoing daily exercise and yoga since the past one year Use of medications like steroids, anticonvulsant or bisphosphonates, SERMs etc, or on any treatment for osteoporosis Lowest T scores at any one site spine/hip below - 3.5 History of any atraumatic fractures like wrist, vertebral fractures etc Non-ambulatory women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measures- Impact on bone health: Increase in bone mineral density over the time period from baseline to 12, and 24 months due to intervention model Changes in bone turnover markers over the time period from baseline to 6, 12, and 24 months due to intervention model Timepoint: Primary Outcome Measures- Impact on bone health: Increase in bone mineral density over the time period from baseline to 12, and 24 months due to intervention model Changes in bone turnover markers over the time period from baseline to 6, 12, and 24 months due to intervention model | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life Changes ( Time Frame: baseline, 6,12,18, and 24 months ) Compliance with dietary modifications along with calcium and vitamin D supplementation Compliance with physical activity and yoga i.e. intervention model acceptability and feasibility Timepoint: 0,6,12,18,24 months since recritement | — |
Countries
India
Contacts
National Institute for Research in Reproductive Health (ICMR)