Scoliosis Clinical Trial
Official title:
Preventing Curve Progression and the Need for Bracing in Early Diagnosed Adolescent Idiopathic Scoliosis Using Calcium Plus Vitamin D Supplementation - A Randomized Double-blinded Placebo-controlled Trial
There is an association between adolescent idiopathic scoliosis (AIS) and low bone mass which has been reported to be a significant prognostic factor for curve progression. Given that dietary calcium (Ca) intake and serum Vit-D levels were also low in AIS, we therefore propose a randomized double-blinded placebo-controlled trial to evaluate if daily [500mg Ca + 800 IU Vit-D] can improve bone health and prevent curve progression in AIS. Immature AIS girls with Cobb angle 10-20 degrees will be randomized either to the Treatment or Placebo group with 3-year of treatment. The main outcome measures for evaluation for those who have completed the 3-year treatment and have reached skeletal maturity at the end of 3-year treatment include: (1) percentage of patients with increase in Cobb angle≥6 degrees and (2) percentage of patients who require bracing. Bone measurements using advanced image acquisition technology(HR-pQCT) to assess bone health will also be evaluated.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 10 Years to 14 Years |
Eligibility | Inclusion Criteria: 1. girls with diagnosis of AIS confirmed after detailed clinical and radiological assessment and 2. between 10 to 14 years old and 3. Risser between 0 to 2 and 4. pre-menarche or < 1 year post-menarche and 5. Cobb angle between 10° to 20 ° and 6. no prior bracing or other treatment for scoliosis and 7. no prior treatment for bone health Exclusion Criteria: 1. scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia or 2. patients with known endocrine and connective tissue abnormalities, or 3. patients with eating disorders or gastrointestinal malabsorption disorders or any disorders that are known to affect calcium or bone metabolism or 4. prior treatment for bone health before being recruited into the study or 5. patient currently taking medication that affects bone metabolism eg steroid or 6. patient with contra-indications for calcium and Vit-D supplementation: 1. history of hypersensitivity to the active or placebo tablets 2. history of renal diseases and renal calculi (nephrolithiasis) 3. diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria 4. hypervitaminosis D |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Orthopaedics and Traumatology, Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Curve progression (Cobb) | Percentage of patients with increase in Cobb angle = 6 degrees | 3 years | |
Primary | Curve progression (Bracing) | Percentage of patients who require bracing | 3 years | |
Secondary | Bone health (BMD) | Improvement in areal bone mineral density measured with Dual-energy X-ray absorptiometry | 3 years | |
Secondary | Bone health (bone quality) | Improvement in bone quality measured with High-resolution peripheral quantitative computed tomography | 3 years |
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