Preventing Curve Progression and the Need for Bracing in Adolescent Idiopathic Scoliosis With Calcium + Vitamin D Supplementation

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03533010
• Other study ID #: CalE_Protocol_V04
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2023
• Source: Chinese University of Hong Kong
• Contact: Tsz Ping Lam
• Phone: 35052724
• Email: tplam[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study investigates if calcium (Ca) plus Vitamin D (Vit-D) supplementation can prevent curve progression and improve bone health in early Adolescent Idiopathic Scoliosis (AIS) during pubertal growth.

AIS is a prevalent three-dimensional spinal deformity mainly affecting girls at puberty. It can lead to serious complications including spine degeneration, cardiopulmonary compromise, grossly deformed torso and psychosocial disorders. Current treatments are far from being satisfactory, with bracing being lengthy and physically demanding and surgery being a major invasive procedure.

There is an association between AIS and low bone mass which has been reported to be a significant prognostic factor for curve progression. Given that dietary calcium 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. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bone Health
• Scoliosis
• Spinal Curvatures
• Spinal Diseases
• Vitamin D

Intervention

Dietary Supplement:
• Ca500mg
subjects receive a daily dose of 500mg elemental calcium
• VitD800IU
subjects receive a daily dose of 800IU VitD3

Other:
• Placebo
subjects receive placebo tablet

Locations

Country	Name	City	State
Hong Kong	Department of Orthopaedics and Traumatology, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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