Effects of Melatonin on Bone Metabolism in Thalassemia Patients with Low Bone Mineral Density (Randomized Controlled Study)
- Conditions
- ow bone mineral density (BMD Z-score less than DŽ.0)ThalassemiaIron overloadOsteoporosisThalassemiaIron Overload
- Registration Number
- TCTR20201223008
- Lead Sponsor
- Faculty of Medicine, Chiang Mai university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 64
1. Male or premenopausal female with age 19-50 years
2. Thalassemia disease, either TDT or NTDT, confirmed by hemoglobin typing (High Performance Liquid Chromatography method) or PCR for thalassemia gene result
3. Iron overload defined as serum ferritin more than 1,000 ng/ml in TDT or 800 ng/ml in NTDT
4. The axial BMD is less than -2 standard deviation of the reference value for that age (Z-score < -2.0)
5. Physically fit defined as ECOG performance status 0-1
1. Currently use or history of any bone modifying agent use within 1 year before enrollment: bisphosphonates, RANKL inhibitor, sclerostin inhibitor, SERMs, strontium ranelate (not include calcium and vitamin D)
2. Pregnancy or breastfeeding
3. History of allergy or severe adverse event from melatonin
4. Cannot evaluate BMD by DXA at L-spine and hips
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean difference of BMD at L-spine 12 months BMD
- Secondary Outcome Measures
Name Time Method Mean difference of BMD at proximal femur 12 months BMD,Serum bone turnover marker (CTX, P1NP) differences between groups 6, 12 months Blood,Pain score differences between groups 6, 12 months Questionnaire (Numeric rating scale),changes of serum NTBI, hepcidin 6, 12 months Blood,changes of plasma F2-isoprostanes, melatonin, calcitonin, FGF21 level 6, 12 months Blood,Adverse events 3, 6, 9, 12 months Questionnaire