Thalassemia-associated osteoporosis Thalassemia Osteoporosis Alendronate Bone Density P1NP peptide CTx telopeptide Iron Overload
Conditions
Interventions
Alendronate sandoz (70 mg/tablet)
1 tablet orally once weekly 30 minutes before meal
Experimental Drug
Alendronate
Sponsors
Faculty of Medicine, Chiang Mai University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed thalassemia disease (both transfusion-dependent and non-transfusion-dependent) 2. Bone mineral density at hip or lumbar spine or total body Z-score < -2.0 SD by Dual Energy X-ray Absorptiometry (DXA) or have vertebral deformity/fracture seen from vertebral fracture analysis (VFA) 3. ECOG performance status 0-2
Exclusion criteria
Exclusion criteria: 1. Currently or ever use bisphosphonate drug 2. Creatinine clearance less than 35 ml/min/1.73 sq.m 3. Hypocalcemia 4. Esophageal disorder or abnormality, or cannot maintain upright position for 30 minutes after take the drug 5. Uncorrected dental problem 6. Pregnancy 7. Herb use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density (BMD) 1 year Dual Energy X-ray Absorptiometry (DXA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum bone turnover markers (BTMs): P1NP, CTx 6 months, 1 year Blood test,Back pain, bone pain 6 months, 1 year Visual analog scale,Prevalence of vitamin D deficiency and insufficiency baseline Blood test,Prevalence of endocrinopathy baseline history taking, physical examination, blood test,Prevelence of vertebral fracture or deformity baseline Vertebral fracture analysis by DXA,non-transferrin-bound iron (NTBI), labile plasma iron (LPI), hepcidin baseline blood test | — |
Countries
Thailand
Contacts
Public ContactAdisak Tantiworawit
Faculty of Medicine, Chiang Mai University
Outcome results
None listed