ScoliosisNCT02904421
6 Years Study on Changes in Bone Quality, Bone Turnover and Curve Severity in AIS With and Without Calcium and Vit-D Supplementation
An observational study of Scoliosis and Vitamin D, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The study aimed to: 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: 1. Read more about this study
- Who is it for?
- Ages 16 to 21 years, women only
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 21 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Subjects from the Cal study
Who cannot join
- Subjects that are pregnant
- Subjects with fracture
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Orthopaedics and Traumatology, Prince of Wales Hospital
Hong Kong, Hong Kong
About this study
Official title: A Six Years Longitudinal Cohort Study on the Changes in Bone Density, Bone Quality and Its Association With Bone Turnover Markers and Curve Severity in Adolescent Idiopathic Scoliosis With and Without 2 Years of Calcium and Vit-D Supplementation
The study aimed to:
- 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:
- Group A: subjects followed at a mean of 4 years after completion of 2-year calcium and Vit-D supplementation and
- Group B: subjects without calcium and Vit-D supplementation
- 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
Read the detailed description
Adolescent Idiopathic Scoliosis (AIS) is a complex three-dimensional spinal deformity mostly affecting girls in the peri-pubertal period. Prevalence ranges from 2 to 4% in the general population. When the deformity becomes severe, serious morbidities can occur including early back degeneration, cardiopulmonary compromise, grossly deformed torso and associated psychosocial issues which could pose serious health threats for these young patients.
One important health threat that deserves special attention is osteopenia as defined by Bowden et al. for children having BMD age and gender-adjusted Z-score < -1. 30-38% of AIS girls were osteopenic. Osteopenia could persist across puberty and was found to be a significant and independent prognostic factor for curve progression in AIS. Osteopenia was also found to be associated with low dietary calcium (Ca) intake at a median of 400mg/day among AIS girls. The low Ca intake was significantly correlated with age-adjusted peripheral volumetric bone mineral density (vBMD) measured by peripheral quantitative computed tomography (pQCT), as well as axial and peripheral areal BMD (aBMD) measured by Dual-Energy X-ray Absorptiometry (DXA).
Low calcium intake when coupled with low Vit-D status can seriously affect a child's bone health. Without Vit-D, only 10 to 15% of dietary calcium is absorbed, and 1,25-(OH)2Vit-D can increase intestinal calcium absorption to 30-40%. Vit-D insufficiency or disturbance in Vit-D physiology is associated with osteopenia, deranged muscle function and ligamentous laxity which could potentially predispose AIS subjects to curve progression.
Given that serum 25(OH)Vit-D level was also found to be low at a mean level of 41.6 nmol/L among AIS subjects, our group has conducted the first 2-year randomized double-blinded placebo-controlled trial using calcium and Vit-D supplementation for young AIS girls with low bone mass (the Cal study). There were three study groups in the trial, namely Group 1 (the placebo group), Group 2 (the low-dose treatment group with 600mg calcium + 400IU Vit-D3/day) and Group 3 (the high-dose treatment group with 600mg calcium + 800IU Vit-D3/day). The study showed strong evidences of positive bone accretion effects and therapeutic control of curve progression in groups with supplementation (Group 2 and 3). Following the therapeutic gain in BMD and improvement in bone quality with 2-year intervention with calcium and Vit-D supplementation, it will be important to evaluate if the effects persist after supplement withdrawal. This study would help to address this key issue by evaluating whether the beneficial effects of 2-year calcium and Vit-D supplementation persist at an average of 4 years after withdrawal of supplementation. The BMD, trabecular bone micro-architecture, bone strength, image-based and serum bone turnover parameters, and curve severity at 4 years after withdrawal of supplement would be compared with measurements done before and at end of supplementation.
Outcome of this study will provide important scientific data on the long term effects of 2-year calcium and Vit-D supplementation, thus justifying the need of lifestyle modification, duration and dose of supplementation for better bone health and curve control in adolescents suffering from AIS. If the beneficial effects are proven to be sustainable, the 2-year calcium and Vit-D supplements can be incorporated into the treatment protocol for AIS not only in Hong Kong, but also in Mainland China and other parts of the world; otherwise longer period of supplementation for sustained positive bone accretion effects and prevention of curve progression will be desirable for attaining peak bone mass and curve control to prevent osteopenia-related and scoliosis-related complications when approaching adulthood.
This six years longitudinal follow-up study with 2-year active supplementation period and 4-year post-withdrawal follow up for this cohort of adolescent girls is unique. Not only are the effects of calcium and vitamin D supplementation being followed, the placebo group in the original clinical trial provides the longitudinal changes on anthropometric, bone density, bone quality parameters and curve severity which will yield important reference information for local adolescents with AIS.
- Keywords
- scoliosis, spinal deformity, vitamin D, bone health
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
The dietary intake and physical activity data are recorded as covariates for statistical analysis on bone changes of the study groups.
Measured: 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
Detail anthropometric measurements including body height, weight, arm span will be measured with standard stadiometry techniques.
Measured: baseline, end of 2 year supplementation, 4 years post-treatment follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsz-ping Lam, Chinese University of Hong Kong
- Investigators
- Tsz Ping Lam, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904421
- Sponsor's protocol ID
- CALTC4_v1
- Status last verified
- Dec 2019
- First submitted
- 4 Sep 2016
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six Years Longitudinal Cohort Study on the Changes in Bone Density, Bone Quality and Its Association With Bone Turnover Markers and Curve Severity in Adolescent Idiopathic Scoliosis With and Without 2 Years of Calcium and Vit-D Supplementation
- ClinicalTrials.gov ID
- NCT02904421
- Acronym / sponsor ID
- CALTC4_v1
- Keywords
- scoliosis, spinal deformity, vitamin D, bone health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to:
- 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:
- Group A: subjects followed at a mean of 4 years after completion of 2-year calcium and Vit-D supplementation and
- Group B: subjects without calcium and Vit-D supplementation
- 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
Detailed description
Adolescent Idiopathic Scoliosis (AIS) is a complex three-dimensional spinal deformity mostly affecting girls in the peri-pubertal period. Prevalence ranges from 2 to 4% in the general population. When the deformity becomes severe, serious morbidities can occur including early back degeneration, cardiopulmonary compromise, grossly deformed torso and associated psychosocial issues which could pose serious health threats for these young patients.
One important health threat that deserves special attention is osteopenia as defined by Bowden et al. for children having BMD age and gender-adjusted Z-score < -1. 30-38% of AIS girls were osteopenic. Osteopenia could persist across puberty and was found to be a significant and independent prognostic factor for curve progression in AIS. Osteopenia was also found to be associated with low dietary calcium (Ca) intake at a median of 400mg/day among AIS girls. The low Ca intake was significantly correlated with age-adjusted peripheral volumetric bone mineral density (vBMD) measured by peripheral quantitative computed tomography (pQCT), as well as axial and peripheral areal BMD (aBMD) measured by Dual-Energy X-ray Absorptiometry (DXA).
Low calcium intake when coupled with low Vit-D status can seriously affect a child's bone health. Without Vit-D, only 10 to 15% of dietary calcium is absorbed, and 1,25-(OH)2Vit-D can increase intestinal calcium absorption to 30-40%. Vit-D insufficiency or disturbance in Vit-D physiology is associated with osteopenia, deranged muscle function and ligamentous laxity which could potentially predispose AIS subjects to curve progression.
Given that serum 25(OH)Vit-D level was also found to be low at a mean level of 41.6 nmol/L among AIS subjects, our group has conducted the first 2-year randomized double-blinded placebo-controlled trial using calcium and Vit-D supplementation for young AIS girls with low bone mass (the Cal study). There were three study groups in the trial, namely Group 1 (the placebo group), Group 2 (the low-dose treatment group with 600mg calcium + 400IU Vit-D3/day) and Group 3 (the high-dose treatment group with 600mg calcium + 800IU Vit-D3/day). The study showed strong evidences of positive bone accretion effects and therapeutic control of curve progression in groups with supplementation (Group 2 and 3). Following the therapeutic gain in BMD and improvement in bone quality with 2-year intervention with calcium and Vit-D supplementation, it will be important to evaluate if the effects persist after supplement withdrawal. This study would help to address this key issue by evaluating whether the beneficial effects of 2-year calcium and Vit-D supplementation persist at an average of 4 years after withdrawal of supplementation. The BMD, trabecular bone micro-architecture, bone strength, image-based and serum bone turnover parameters, and curve severity at 4 years after withdrawal of supplement would be compared with measurements done before and at end of supplementation.
Outcome of this study will provide important scientific data on the long term effects of 2-year calcium and Vit-D supplementation, thus justifying the need of lifestyle modification, duration and dose of supplementation for better bone health and curve control in adolescents suffering from AIS. If the beneficial effects are proven to be sustainable, the 2-year calcium and Vit-D supplements can be incorporated into the treatment protocol for AIS not only in Hong Kong, but also in Mainland China and other parts of the world; otherwise longer period of supplementation for sustained positive bone accretion effects and prevention of curve progression will be desirable for attaining peak bone mass and curve control to prevent osteopenia-related and scoliosis-related complications when approaching adulthood.
This six years longitudinal follow-up study with 2-year active supplementation period and 4-year post-withdrawal follow up for this cohort of adolescent girls is unique. Not only are the effects of calcium and vitamin D supplementation being followed, the placebo group in the original clinical trial provides the longitudinal changes on anthropometric, bone density, bone quality parameters and curve severity which will yield important reference information for local adolescents with AIS.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Subjects from the Cal study
Key exclusion criteria (2 listed)
- Subjects that are pregnant
- Subjects with fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline clinical features of scoliosis at end of 2 year supplementation and at 4 years post-treatment follow up
Time frame: baseline, end of 2 year supplementation, 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.
Change from baseline BMD Measurement at end of 2 year supplementation and at 4 years post-treatment follow up
Time frame: baseline, end of 2 year supplementation, 4 years post-treatment follow up
Areal BMD (g/cm2) and BMC (g/cm) of bilateral hips (femoral neck) will be measured by DXA.
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
Time frame: baseline, end of 2 year supplementation, 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.
Change from baseline bone mechanical strength at end of 2 year supplementation and at 4 years post-treatment follow up
Time frame: baseline, end of 2 year supplementation, 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.
Change from baseline biochemical markers for bone formation and resorption at end of 2 year supplementation and at 4 years post-treatment follow up
Time frame: baseline, end of 2 year supplementation, 4 years post-treatment follow up
Serum P1NP and β-CTx will be assayed to determine bone formation and resorption activity.
Change from baseline serum Vitamin D concentration at end of 2 year supplementation and at 4 years post-treatment follow up
Time frame: baseline, end of 2 year supplementation, 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).
2 secondary outcomes
Change from baseline dietary intakes and physical activity at end of 2 year supplementation and at 4 years post-treatment follow up
Time frame: 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
Time frame: baseline, end of 2 year supplementation, 4 years post-treatment follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsz Ping Lam principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis and Vitamin D, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline clinical features of scoliosis at end of 2 year supplementation and at 4 years post-treatment follow up (time frame: baseline, end of 2 year supplementation, 4 years post-treatment follow up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019; AzTrials last refreshed its copy on 29 Oct 2026.