Health Condition 1: M80- Osteoporosis with current pathological fracture Health Condition 2: M81- Osteoporosis without current pathological fracture
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant having postmenopausal osteoporosis (diagnosed clinically and /or by Bone Densitometry/ DXA scan) and T-score -2.5 or below as per criteria. (WHO criteria) 2. Participant of diagnosed PMO with current pathological fracture and asymptomatic. 3. Postmenopausal women aged 45 to 65years of age. 4. Postmenopausal for at least 1 year (Menopause as having permanent cessation of menses for at least 12 months (as per current guidelines) without any other obvious pathological or physiological cause. 5. Participants who are not under any therapy or medications for PMO 6. Participant willing to give consent for the study
Exclusion criteria
Exclusion criteria: 1. Participant who are suffering secondary osteoporosis and serious illness /or suffering from critical illness 2. Participants who are pregnant or/ and lactating mothers and those who have glucocorticoid-induced osteoporosis 3. Deranged renal function, any significant liver disease 4. Participant who has received estrogen replacement therapy (within the previous 12 months. 5. Participant who are severely drug/alcohol addicted. 6. Participants having mental and behavioral disorders due to psychoactive substance other than tobacco
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T-SCORE with help of DEXA scan Changes in Bone mass densityTimepoint: Baseline, 12 months and 30 Months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum Calcium, Serum 25-hydroxyvitamin DTimepoint: Baseline, 12months and 30 Months (End Of Treatment );QUALEFFO-41,Quality of Life for Osteoporosis, Osteoporosis Assessment Questionnaire-Physical FunctionTimepoint: Baseline/16Week/6 Months/9Months/12 Months till end treatment. | — |
Countries
India
Contacts
DACRRI(H).Kolkata