Post-menopausal osteoporosis
Conditions
Interventions
1. Post-menopausal women will be recruited from Bope-Poddala MOH area in Galle using latest electoral registers.
2. Participants who fulfill the eligibility criteria with high fracture risk will be
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed post-menopausal females with high fracture risk. Fracture risk assessment: The fracture risk will be assessed based on FRAX algorithm using clinical risk factors and bone mineral density values. Women with major fracture risk >10% and/or hip fracture risk >3% will be considered to have a high fracture risk. Lekamwasam S, (2013), Sri Lankan FRAX model and country-specific intervention thresholds. Arch Osteoporos;8:148.
Exclusion criteria
Exclusion criteria: 1. Females with a history of significant neuroendocrine disorder that affect the BTMs (disorders of thyroid gland like hyperthyroidism and disorders of parathyroid glands such as hyperparathyroidism and hypoparathyroidism) 2. Treatment with anticonvulsant, thyroxin and hydrochlorothiazide that affect the vitamin D and calcium metabolism 3. Chronic kidney disease stage 4 or 5 (when eGFR is less than <30 mL min-1 per 1.73 m2) 4. Chronic liver disease (clinically evident) 5. Other metabolic or inherited bone diseases other than postmenopausal bone loss including Paget’s disease and osteomalacia 6. Rheumatoid arthritis or collagen disease 7. Subjects with malignancies 8. Immobilized or disabled subjects due to cerebrovascular disease 9. Gastric surgery, major gastrointestinal disease that causes significant malabsorption, 10. Use of any systemic steroid (prednisolone, dexamethasone or equivalent), 11. Use of bisphosphonates within the year directly preceding the study 12. Other anti-osteoporotic drugs (selective oestrogen receptor modulators and calcitonin) and calcium, vitamin supplement during the last three months 13. Women who have experienced early menopause (before 45 years of age) 14. Women who have undergone any therapy which can affect the bone metabolism (hormone replacement therapy andandrogen-stimulating therapy) 15. Women who are known to take antipsychotics and antiepileptic sodium valproate 16. Fracture during the last one year 17. Acute illness at the time of recruitment or during last 3 months 18. Allergy for bisphosphonates
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction of the serum concentrations of selected bone turnover markers. 1) CTX (carboxy terminal telopeptide of collagen type I), 2) PINP (procollagen type I N-terminal pro-peptide) [At the baseline and at 24th week after the commencement of the intervention.] | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability measured by the rate of "dropouts" due to the adverse effects of alendronate Adverse effects of medications - upper GI tract symptoms (i.e. abdominal pain, nausea, vomiting [At the 24th week after commencement of the intervention.] | — |
Countries
Sri Lanka
Contacts
Public ContactMrs. M R P Hasanga
Lecturer (Probationary)
Outcome results
None listed