A Phase 2 interventional study of Alphacalcidol in Scoliosis; Adolescence, sponsored by University of Ioannina. Recruiting at 2 sites in Greece. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by University of Ioannina · Phase 2, Interventional, and Treatment
The purpose of this current prospective study is to determine the role of vitamin D in the development and restoration of spinal deformities in adolescence.
The investigator will record the medical history of each patient and information such as age, body size (weight, height) and body mass index (BMI = kg / m \^ 2). Girls will also be given the time of appearance of menstruation, a factor that needs to be evaluated because the growth of the skeleton continues three years after its appearance. Patients will be subjected to Adam's Test, x-ray's and as well as lateral bending radiographs.In the first contact with each patient, will be evaluated bone density measured by DEXA as well as haematological testing including PTH, alkaline phosphatase (ALP), calcium (Ca), phosphorus( P ), Calcitonin and, of course, vitamin D (total and metabolite 25 (OH) D).
Each patient's follow-up will be completed in two years by a clinical examination every six months and a clinical, laboratory and radiological examination per year. Patients will be divided into two groups. In a group with patients with normal 25 (OH) D and in a second group with patients with low levels of 25 (OH) D. Members of the second group will receive substitution treatment with an appropriate formulation. The results will be collected and evaluated using statistical programme.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's planned enrollment of 80 is above the median of 44 across 344 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →University of Ioannina is the lead sponsor of 53 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0,5mg tablet by mouth, one each day for one year
Drug: Alphacalcidol
Alphacalcidol 0,5mg tablet
25(OH)D
Measurement of the major metabolite of vitamin D
Time frame: 48 weeks
X - rays
Cobb angle measurement
Time frame: 48 weeks
Dexa
BMD and Z - score measurement
Time frame: 48 weeks
BMD (weight in kilograms, height in meters)
weight and height will be combined to report BMI in kg/m\^2
Time frame: 48 weeks
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University of Ioannina