6 Years Study on Changes in Bone Quality, Bone Turnover and Curve Severity in AIS With and Without Calcium and Vit-D Supplementation

NCT02904421 | Completed

• 1 other identifier: CALTC4_v1
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to:

1. 1.To investigate and compare the changes in bone mineral density (BMD), trabecular bone micro-architecture, bone strength, and curve severity at a mean of 6 years longitudinal follow up in AIS girls with low bone mass between Group A and B:
2. 2.Group A: subjects followed at a mean of 4 years after completion of 2-year calcium and Vit-D supplementation and
3. 3.Group B: subjects without calcium and Vit-D supplementation
4. 4.To evaluate the correlation between changes in BMD, trabecular bone micro-architecture, and bone strength documented in Objective 1 with changes in serum bone turnover markers

Conditions

Scoliosis; Vitamin D; Bone

Keywords

scoliosis; spinal deformity; vitamin D; bone health

Outcome Measures

Primary Outcomes (6)

• Change from baseline clinical features of scoliosis at end of 2 year supplementation and at 4 years post-treatment follow up

  A long standard standing postero-anterior (PA) whole spine radiograph will be used for grading curve severity in terms of Cobb angle according to the standard Cobb method.

  baseline, end of 2 year supplementation, 4 years post-treatment follow up

• Change from baseline BMD Measurement at end of 2 year supplementation and at 4 years post-treatment follow up

  Areal BMD (g/cm2) and BMC (g/cm) of bilateral hips (femoral neck) will be measured by DXA.

  baseline, end of 2 year supplementation, 4 years post-treatment follow up

• Change from baseline volumetric BMD (vBMD), bone geometry and trabecular bone micro-architecture at end of 2 year supplementation and at 4 years post-treatment follow up

  Detailed bone measurement of the non-dominant distal radius will be carried out with the in-vivo HR-pQCT using an established measurement protocol.

  baseline, end of 2 year supplementation, 4 years post-treatment follow up

• Change from baseline bone mechanical strength at end of 2 year supplementation and at 4 years post-treatment follow up

  Finite element analysis (FEA) will be used to assess the bone strength non-invasively. Finite element (FE) models of the radius will be created directly from the HR-pQCT images using Scanco FE solver integrated in the IPL software.

  baseline, end of 2 year supplementation, 4 years post-treatment follow up

• Change from baseline biochemical markers for bone formation and resorption at end of 2 year supplementation and at 4 years post-treatment follow up

  Serum P1NP and β-CTx will be assayed to determine bone formation and resorption activity.

  baseline, end of 2 year supplementation, 4 years post-treatment follow up

• Change from baseline serum Vitamin D concentration at end of 2 year supplementation and at 4 years post-treatment follow up

  Serum 25(OH)Vit-D concentrations will be measured by liquid chromatography isotope-dilution electrospray ionization tandem mass spectrometry (LCTMS).

  baseline, end of 2 year supplementation, 4 years post-treatment follow up

Secondary Outcomes (2)

• Change from baseline dietary intakes and physical activity at end of 2 year supplementation and at 4 years post-treatment follow up

  baseline, end of 2 year supplementation, 4 years post-treatment follow up

• Change from baseline anthropometric measurements and maturity assessment at end of 2 year supplementation and at 4 years post-treatment follow up

  baseline, end of 2 year supplementation, 4 years post-treatment follow up

Study Arms (3)

Group 1

the placebo group

Group 2

the low-dose treatment group with 600mg calcium + 400IU Vit-D3/day

Group 3

the high-dose treatment group with 600mg calcium + 800IU Vit-D3/day

Eligibility Criteria

• Age: 16 Years - 21 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All 330 subjects from the Cal study will be invited to participate. Order of recruitment will follow the order of recruitment during the initial study at a first-entry first-serve basis.

You may qualify if:

• Subjects from the Cal study

You may not qualify if:

• Subjects that are pregnant
• Subjects with fracture

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Orthopaedics and Traumatology, Prince of Wales Hospital

Hong Kong, Hong Kong, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Tsz Ping Lam

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 4, 2016
• First Posted: September 19, 2016
• Study Start: October 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

CN (1)