Achondroplasia
Conditions
Brief summary
This is a registry study in children with achondroplasia, age 0-10 years, to be conducted at multiple clinical centers in several countries. Information collected will include in anthropometric characteristics, related symptoms, tests, & treatments Children's information will be collected in the registry for a maximum of 5 years.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent is obtained from the children's parent(s) / legal guardian(s) before any study-related activity is carried out 2. The child is able to provide written informed assent, where this is required according to national legislation, before any study related activity is carried out 3. The child has been diagnosed as having achondroplasia documented by clinical diagnosis 4. The child is between 0 years and 10 years of age, inclusive, on the date of consent / assent 5. The investigator has considered the family and prospective participating child being able to comply with the study procedures
Exclusion criteria
1. The child has a diagnosis of hypochondroplasia or any short stature condition other than achondroplasia (eg, spondyloepiphyseal dysplasia congenital \[SEDC\], pseudoachondroplasia, trisomy 21) 2. The child has any medical condition that may impact growth or where the treatment is known to impact growth, such as but not limited to hypothyroidism or hyperthyroidism, insulin-requiring diabetes mellitus, autoimmune inflammatory disease (including celiac disease, systemic lupus erythematosus \[SLE\], juvenile dermatomyositis, scleroderma, and others), autonomic neuropathy, or inflammatory bowel disease 3. Treatment in the previous 12 months prior to consent and assent with growth hormone, insulin-like growth factor 1 (IGF-1), anabolic steroids, or any other drug expected to affect growth velocity 4. Any surgery that affects the growth plate of the long bones that is planned, or has occurred in the past 18 months 5. Participation in any interventional study (investigational product or device) for treatment of achondroplasia or short stature 6. Has had bone-related surgery impacting assessment of anthropometric measurements or is expected to have it during the study period. Children with previous limb-lengthening surgery may enroll if surgery occurred at least 18 months prior to the date of consent/assent and healing is complete without sequelae as determined by the investigator 7. Has any condition that in the view of the investigator places the child at high risk of poor compliance with the visit schedule or of not completing the study. 8. Any concurrent disease or condition that in the view of the investigator would interfere with study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Knee Height | Baseline, 1 year, 2 years, 3 years, 4 years | Knee height means lower segment length (lower segment=standing height - sitting height). Knee height was measured using knee height caliper. Three valid measurements were performed at each visit and the average of the 3 valid measurements was reported and used in descriptive summaries. Data is reported according to age group (\<2 years, 2-10 years, and ≥10 years) and gender of the participants. |
| Change From Baseline in Standing Height | Baseline, 1 year, 2 years, 3 years, 4 years | Standing height (for participants aged ≥2 years) is an assessment of maximum vertical size. Standing height was measured using a stadiometer with a fixed vertical backboard and an adjustable head piece. Height in supine position (or length for participants aged \<2 years) was measured using measuring board. Three valid measurements were performed at each visit and the average of the 3 valid measurements was reported and used in descriptive summaries. Data is reported according to age group (\<2 years and ≥2 years) and gender of the participants. |
| Change From Baseline in Sitting Height | Baseline, 1 year, 2 years, 3 years, 4 years | Sitting height (for participants aged ≥2 years) is a measure of the trunk of the body from the buttocks to the top of the head when the participant is sitting upright. Sitting height was measured using a stadiometer and sitting height table. Crown-rump length (for participants aged \<2 years) was measured using measuring board. Three valid measurements were performed at each visit and the average of the 3 valid measurements was reported and used in descriptive summaries. Data is reported according to age group (\<2 years and ≥2 years) and gender of the participants. |
| Number of Participants With Achondroplasia-Related Treatments | Baseline to end of study visit (up to 55 months) | Achondroplasia-related treatments were collected in a prospective and standardized fashion to allow characterization of the natural history of the disease course in the youngest participants in relation to the level of actual disease burden over time due to treatments, as well as data to support identification of possible risk factors. Data is reported according to the gender of the participants. |
| Change From Baseline in Head Circumference | Baseline, 1 year, 2 years, 3 years, 4 years | Head circumference is a measurement of the circumference of the child's head at its largest area, above the eyebrows and ears and around the back of the head. Head circumfernce was measured using measuring tape. Three valid measurements were performed at each visit and the average of the 3 valid measurements was reported and used in descriptive summaries. Data is reported according to age group (\<2 years, 2-10 years, and ≥10 years) and gender of the participants. |
| Change From Baseline in Arm Span | Baseline, 1 year, 2 years, 3 years, 4 years | Arm span measurement is the distance between fingertips when the arms are outstretched. All participants should be measured supine lying on the measurement grid. Three valid measurements were performed at each visit and the average of the 3 valid measurements was reported and used in descriptive summaries. Data is reported according to age group (\<2 years, 2-10 years, and ≥10 years) and gender of the participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline and Post-baseline Measurements of Serum Collagen X Marker | Baseline, 1 year, 2 years, 3 years | Collagen X Marker (CXM), is a degradation by-product of endochondral ossification that is released into the circulation in proportion to overall growth plate activity. This marker corresponds to the rate of linear bone growth at time of measurement as recently demonstrated in children of normal average growth. Data is reported according to age group (\<2 years, 2-10 years, and ≥10 years) and gender of the participants. |
Countries
Australia, Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Portugal, Spain, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
This was a prospective, registry study, and conducted at multiple clinical centers globally. A total of 315 participants with eligibility-verified were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Participants Participants with achondroplasia were followed over 4 years with respect to achondroplasia symptoms, tests and treatments, anthropometric parameters and biomarkers of bone growth. No study intervention was administered, and no other type of therapy was provided. | 315 |
| Total | 315 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | At sponsor's request | 151 |
| Overall Study | Inclusion/exclusion criteria | 8 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Other | 10 |
| Overall Study | Physician Decision | 1 |
| Overall Study | The child is enrolled in an interventional study | 70 |
| Overall Study | Withdrawal by Subject | 66 |
Baseline characteristics
| Characteristic | Enrolled Participants |
|---|---|
| Age, Customized 0-2 Years | 82 Participants |
| Age, Customized ≥10 Years | 18 Participants |
| Age, Customized 2-10 Years | 213 Participants |
| Age, Customized Missing age | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 288 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race/Ethnicity, Customized Asian | 52 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants |
| Race/Ethnicity, Customized Not Applicable | 4 Participants |
| Race/Ethnicity, Customized Other | 24 Participants |
| Race/Ethnicity, Customized White | 233 Participants |
| Sex: Female, Male Female | 137 Participants |
| Sex: Female, Male Male | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 315 |
| other Total, other adverse events | 0 / 315 |
| serious Total, serious adverse events | 0 / 315 |
Outcome results
Primary
Change From Baseline in Arm Span
Arm span measurement is the distance between fingertips when the arms are outstretched. All participants should be measured supine lying on the measurement grid. Three valid measurements were performed at each visit and the average of the 3 valid measurements was reported and used in descriptive summaries. Data is reported according to age group (\<2 years, 2-10 years, and ≥10 years) and gender of the participants.
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years
Population: Analysis population included all enrolled participants, among whom, 2 participants have not been included due to missing age. The Overall Number of Participants Analyzed was based on age at baseline. The Number Analyzed in a row was based on actually analyzed participants at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Male (Aged <2 Years) | Change From Baseline in Arm Span | Change at 2 years | 12.8 cm | Standard Deviation 2.4 |
| Male (Aged <2 Years) | Change From Baseline in Arm Span | Change at 1 year | 7.7 cm | Standard Deviation 1.94 |
| Male (Aged <2 Years) | Change From Baseline in Arm Span | Baseline | 56.5 cm | Standard Deviation 6.13 |
| Male (Aged <2 Years) | Change From Baseline in Arm Span | Change at 3 years | 17.0 cm | Standard Deviation 2.16 |
| Female (Aged <2 Years) | Change From Baseline in Arm Span | Change at 2 years | 14.3 cm | Standard Deviation 3.16 |
| Female (Aged <2 Years) | Change From Baseline in Arm Span | Baseline | 55.2 cm | Standard Deviation 5.89 |
| Female (Aged <2 Years) | Change From Baseline in Arm Span | Change at 3 years | 17.9 cm | Standard Deviation 4.29 |
| Female (Aged <2 Years) | Change From Baseline in Arm Span | Change at 1 year | 8.6 cm | Standard Deviation 2.02 |
| Male (Aged ≥2 Years) | Change From Baseline in Arm Span | Change at 2 years | 8.6 cm | Standard Deviation 2.24 |
| Male (Aged ≥2 Years) | Change From Baseline in Arm Span | Change at 3 years | 11.6 cm | Standard Deviation 2.71 |
| Male (Aged ≥2 Years) | Change From Baseline in Arm Span | Baseline | 80.5 cm | Standard Deviation 11.07 |
| Male (Aged ≥2 Years) | Change From Baseline in Arm Span | Change at 4 years | 10.1 cm | Standard Deviation 2.19 |
| Male (Aged ≥2 Years) | Change From Baseline in Arm Span | Change at 1 year | 4.2 cm | Standard Deviation 1.63 |
| Female (Aged ≥2 Years) | Change From Baseline in Arm Span | Change at 1 year | 4.4 cm | Standard Deviation 1.76 |
| Female (Aged ≥2 Years) | Change From Baseline in Arm Span | Baseline | 79.4 cm | Standard Deviation 11.51 |
| Female (Aged ≥2 Years) | Change From Baseline in Arm Span | Change at 2 years | 8.7 cm | Standard Deviation 2.41 |
| Female (Aged ≥2 Years) | Change From Baseline in Arm Span | Change at 3 years | 12.4 cm | Standard Deviation 2.69 |
| Male (Aged ≥10 Years) | Change From Baseline in Arm Span | Change at 3 years | 10.7 cm | Standard Deviation 0.96 |
| Male (Aged ≥10 Years) | Change From Baseline in Arm Span | Change at 2 years | 7.2 cm | Standard Deviation 0.88 |
| Male (Aged ≥10 Years) | Change From Baseline in Arm Span | Baseline | 99.3 cm | Standard Deviation 10.09 |
| Male (Aged ≥10 Years) | Change From Baseline in Arm Span | Change at 1 year | -1.1 cm | Standard Deviation 10.93 |
| Female (Aged ≥10 Years) | Change From Baseline in Arm Span | Baseline | 99.3 cm | Standard Deviation 3.54 |
| Female (Aged ≥10 Years) | Change From Baseline in Arm Span | Change at 1 year | 4.2 cm | Standard Deviation 1.16 |
Primary
Change From Baseline in Head Circumference
Head circumference is a measurement of the circumference of the child's head at its largest area, above the eyebrows and ears and around the back of the head. Head circumfernce was measured using measuring tape. Three valid measurements were performed at each visit and the average of the 3 valid measurements was reported and used in descriptive summaries. Data is reported according to age group (\<2 years, 2-10 years, and ≥10 years) and gender of the participants.
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years
Population: Analysis population included all enrolled participants, among whom, 2 participants have not been included due to missing age. The Overall Number of Participants Analyzed was based on age at baseline. The Number Analyzed in a row was based on actually analyzed participants at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Male (Aged <2 Years) | Change From Baseline in Head Circumference | Change at 1 year | 3.8 cm | Standard Deviation 2.31 |
| Male (Aged <2 Years) | Change From Baseline in Head Circumference | Change at 3 years | 4.7 cm | Standard Deviation 2.22 |
| Male (Aged <2 Years) | Change From Baseline in Head Circumference | Baseline | 48.9 cm | Standard Deviation 3.75 |
| Male (Aged <2 Years) | Change From Baseline in Head Circumference | Change at 2 years | 5.6 cm | Standard Deviation 3.27 |
| Female (Aged <2 Years) | Change From Baseline in Head Circumference | Baseline | 47.7 cm | Standard Deviation 3.1 |
| Female (Aged <2 Years) | Change From Baseline in Head Circumference | Change at 1 year | 4.0 cm | Standard Deviation 2.43 |
| Female (Aged <2 Years) | Change From Baseline in Head Circumference | Change at 3 years | 4.6 cm | Standard Deviation 2.88 |
| Female (Aged <2 Years) | Change From Baseline in Head Circumference | Change at 2 years | 5.3 cm | Standard Deviation 2.79 |
| Male (Aged ≥2 Years) | Change From Baseline in Head Circumference | Change at 4 years | 1.1 cm | Standard Deviation 0.09 |
| Male (Aged ≥2 Years) | Change From Baseline in Head Circumference | Change at 2 years | 0.9 cm | Standard Deviation 0.74 |
| Male (Aged ≥2 Years) | Change From Baseline in Head Circumference | Baseline | 55.5 cm | Standard Deviation 2.28 |
| Male (Aged ≥2 Years) | Change From Baseline in Head Circumference | Change at 1 year | 0.6 cm | Standard Deviation 0.7 |
| Male (Aged ≥2 Years) | Change From Baseline in Head Circumference | Change at 3 years | 1.0 cm | Standard Deviation 0.7 |
| Female (Aged ≥2 Years) | Change From Baseline in Head Circumference | Baseline | 54.4 cm | Standard Deviation 2.42 |
| Female (Aged ≥2 Years) | Change From Baseline in Head Circumference | Change at 1 year | 0.4 cm | Standard Deviation 1.02 |
| Female (Aged ≥2 Years) | Change From Baseline in Head Circumference | Change at 2 years | 1.1 cm | Standard Deviation 0.71 |
| Female (Aged ≥2 Years) | Change From Baseline in Head Circumference | Change at 3 years | 1.4 cm | Standard Deviation 0.55 |
| Male (Aged ≥10 Years) | Change From Baseline in Head Circumference | Baseline | 57.2 cm | Standard Deviation 2.56 |
| Male (Aged ≥10 Years) | Change From Baseline in Head Circumference | Change at 3 years | -0.4 cm | Standard Deviation 3.68 |
| Male (Aged ≥10 Years) | Change From Baseline in Head Circumference | Change at 2 years | 1.0 cm | Standard Deviation 0.38 |
| Male (Aged ≥10 Years) | Change From Baseline in Head Circumference | Change at 1 year | 0.2 cm | Standard Deviation 0.43 |
| Female (Aged ≥10 Years) | Change From Baseline in Head Circumference | Baseline | 55.2 cm | Standard Deviation 2.11 |
| Female (Aged ≥10 Years) | Change From Baseline in Head Circumference | Change at 1 year | 0.9 cm | Standard Deviation 0.51 |
Primary
Change From Baseline in Knee Height
Knee height means lower segment length (lower segment=standing height - sitting height). Knee height was measured using knee height caliper. Three valid measurements were performed at each visit and the average of the 3 valid measurements was reported and used in descriptive summaries. Data is reported according to age group (\<2 years, 2-10 years, and ≥10 years) and gender of the participants.
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years
Population: Analysis population included all enrolled participants, among whom, 2 participants have not been included due to missing age. The Overall Number of Participants Analyzed was based on age at baseline. The Number Analyzed in a row was based on actually analyzed participants at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Male (Aged <2 Years) | Change From Baseline in Knee Height | Change at 3 years | 6.2 cm | Standard Deviation 0.95 |
| Male (Aged <2 Years) | Change From Baseline in Knee Height | Baseline | 15.0 cm | Standard Deviation 2.16 |
| Male (Aged <2 Years) | Change From Baseline in Knee Height | Change at 2 years | 4.6 cm | Standard Deviation 1.03 |
| Male (Aged <2 Years) | Change From Baseline in Knee Height | Change at 1 year | 2.3 cm | Standard Deviation 1.39 |
| Female (Aged <2 Years) | Change From Baseline in Knee Height | Change at 3 years | 6.4 cm | Standard Deviation 1.85 |
| Female (Aged <2 Years) | Change From Baseline in Knee Height | Change at 2 years | 4.8 cm | Standard Deviation 1.44 |
| Female (Aged <2 Years) | Change From Baseline in Knee Height | Baseline | 14.0 cm | Standard Deviation 1.92 |
| Female (Aged <2 Years) | Change From Baseline in Knee Height | Change at 1 year | 2.7 cm | Standard Deviation 0.95 |
| Male (Aged ≥2 Years) | Change From Baseline in Knee Height | Change at 1 year | 1.6 cm | Standard Deviation 1 |
| Male (Aged ≥2 Years) | Change From Baseline in Knee Height | Change at 3 years | 4.5 cm | Standard Deviation 2.31 |
| Male (Aged ≥2 Years) | Change From Baseline in Knee Height | Change at 2 years | 3.2 cm | Standard Deviation 1.96 |
| Male (Aged ≥2 Years) | Change From Baseline in Knee Height | Baseline | 22.5 cm | Standard Deviation 3.91 |
| Male (Aged ≥2 Years) | Change From Baseline in Knee Height | Change at 4 years | 3.5 cm | Standard Deviation 1.25 |
| Female (Aged ≥2 Years) | Change From Baseline in Knee Height | Change at 2 years | 3.4 cm | Standard Deviation 1.44 |
| Female (Aged ≥2 Years) | Change From Baseline in Knee Height | Baseline | 21.9 cm | Standard Deviation 3.69 |
| Female (Aged ≥2 Years) | Change From Baseline in Knee Height | Change at 1 year | 1.5 cm | Standard Deviation 0.93 |
| Female (Aged ≥2 Years) | Change From Baseline in Knee Height | Change at 3 years | 5.0 cm | Standard Deviation 1.99 |
| Male (Aged ≥10 Years) | Change From Baseline in Knee Height | Change at 3 years | 3.4 cm | Standard Deviation 0.99 |
| Male (Aged ≥10 Years) | Change From Baseline in Knee Height | Baseline | 29.1 cm | Standard Deviation 3.64 |
| Male (Aged ≥10 Years) | Change From Baseline in Knee Height | Change at 1 year | 1.3 cm | Standard Deviation 0.83 |
| Male (Aged ≥10 Years) | Change From Baseline in Knee Height | Change at 2 years | 2.0 cm | Standard Deviation 0.41 |
| Female (Aged ≥10 Years) | Change From Baseline in Knee Height | Change at 1 year | 1.4 cm | Standard Deviation 0.16 |
| Female (Aged ≥10 Years) | Change From Baseline in Knee Height | Baseline | 27.8 cm | Standard Deviation 2.7 |
Primary
Change From Baseline in Sitting Height
Sitting height (for participants aged ≥2 years) is a measure of the trunk of the body from the buttocks to the top of the head when the participant is sitting upright. Sitting height was measured using a stadiometer and sitting height table. Crown-rump length (for participants aged \<2 years) was measured using measuring board. Three valid measurements were performed at each visit and the average of the 3 valid measurements was reported and used in descriptive summaries. Data is reported according to age group (\<2 years and ≥2 years) and gender of the participants.
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years
Population: Analysis population included all enrolled participants, among whom, 2 participants have not been included due to missing age. The Overall Number of Participants Analyzed was based on age at baseline. The Number Analyzed in a row was based on actually analyzed participants at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Male (Aged <2 Years) | Change From Baseline in Sitting Height | Change at 1 year | 7.5 cm | Standard Deviation 5.66 |
| Male (Aged <2 Years) | Change From Baseline in Sitting Height | Baseline | 46.2 cm | Standard Deviation 4.39 |
| Male (Aged <2 Years) | Change From Baseline in Sitting Height | Change at 2 years | 14.3 cm | Standard Deviation 1.11 |
| Female (Aged <2 Years) | Change From Baseline in Sitting Height | Change at 1 year | 6.7 cm | Standard Deviation 1.49 |
| Female (Aged <2 Years) | Change From Baseline in Sitting Height | Change at 2 years | 10.8 cm | Standard Deviation 3.41 |
| Female (Aged <2 Years) | Change From Baseline in Sitting Height | Baseline | 44.8 cm | Standard Deviation 3.54 |
| Male (Aged ≥2 Years) | Change From Baseline in Sitting Height | Change at 4 years | 6.3 cm | Standard Deviation 1.65 |
| Male (Aged ≥2 Years) | Change From Baseline in Sitting Height | Baseline | 61.3 cm | Standard Deviation 6.78 |
| Male (Aged ≥2 Years) | Change From Baseline in Sitting Height | Change at 2 years | 4.9 cm | Standard Deviation 1.49 |
| Male (Aged ≥2 Years) | Change From Baseline in Sitting Height | Change at 3 years | 7.0 cm | Standard Deviation 1.74 |
| Male (Aged ≥2 Years) | Change From Baseline in Sitting Height | Change at 1 year | 2.6 cm | Standard Deviation 1.06 |
| Female (Aged ≥2 Years) | Change From Baseline in Sitting Height | Change at 2 years | 5.6 cm | Standard Deviation 1.27 |
| Female (Aged ≥2 Years) | Change From Baseline in Sitting Height | Baseline | 59.9 cm | Standard Deviation 6.64 |
| Female (Aged ≥2 Years) | Change From Baseline in Sitting Height | Change at 1 year | 2.9 cm | Standard Deviation 1.11 |
| Female (Aged ≥2 Years) | Change From Baseline in Sitting Height | Change at 3 years | 7.8 cm | Standard Deviation 1.85 |
Primary
Change From Baseline in Standing Height
Standing height (for participants aged ≥2 years) is an assessment of maximum vertical size. Standing height was measured using a stadiometer with a fixed vertical backboard and an adjustable head piece. Height in supine position (or length for participants aged \<2 years) was measured using measuring board. Three valid measurements were performed at each visit and the average of the 3 valid measurements was reported and used in descriptive summaries. Data is reported according to age group (\<2 years and ≥2 years) and gender of the participants.
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years
Population: Analysis population included all enrolled participants, among whom, 2 participants have not been included due to missing age. The Overall Number of Participants Analyzed was based on age at baseline. The Number Analyzed in a row was based on actually analyzed participants at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Male (Aged <2 Years) | Change From Baseline in Standing Height | Change at 1 year | 8.4 centimeter (cm) | Standard Deviation 5.74 |
| Male (Aged <2 Years) | Change From Baseline in Standing Height | Change at 2 years | 18.8 centimeter (cm) | Standard Deviation 1.72 |
| Male (Aged <2 Years) | Change From Baseline in Standing Height | Baseline | 64.1 centimeter (cm) | Standard Deviation 6.5 |
| Female (Aged <2 Years) | Change From Baseline in Standing Height | Change at 1 year | 9.6 centimeter (cm) | Standard Deviation 2.53 |
| Female (Aged <2 Years) | Change From Baseline in Standing Height | Baseline | 61.8 centimeter (cm) | Standard Deviation 5.27 |
| Female (Aged <2 Years) | Change From Baseline in Standing Height | Change at 2 years | 15.7 centimeter (cm) | Standard Deviation 4.94 |
| Male (Aged ≥2 Years) | Change From Baseline in Standing Height | Change at 4 years | 11.6 centimeter (cm) | Standard Deviation 2.03 |
| Male (Aged ≥2 Years) | Change From Baseline in Standing Height | Baseline | 90.7 centimeter (cm) | Standard Deviation 12.26 |
| Male (Aged ≥2 Years) | Change From Baseline in Standing Height | Change at 2 years | 8.8 centimeter (cm) | Standard Deviation 2.03 |
| Male (Aged ≥2 Years) | Change From Baseline in Standing Height | Change at 3 years | 12.5 centimeter (cm) | Standard Deviation 2.69 |
| Male (Aged ≥2 Years) | Change From Baseline in Standing Height | Change at 1 year | 4.6 centimeter (cm) | Standard Deviation 1.3 |
| Female (Aged ≥2 Years) | Change From Baseline in Standing Height | Change at 2 years | 9.0 centimeter (cm) | Standard Deviation 2.01 |
| Female (Aged ≥2 Years) | Change From Baseline in Standing Height | Baseline | 88.8 centimeter (cm) | Standard Deviation 11.52 |
| Female (Aged ≥2 Years) | Change From Baseline in Standing Height | Change at 1 year | 4.8 centimeter (cm) | Standard Deviation 1.44 |
| Female (Aged ≥2 Years) | Change From Baseline in Standing Height | Change at 3 years | 13.4 centimeter (cm) | Standard Deviation 2.79 |
Primary
Number of Participants With Achondroplasia-Related Treatments
Achondroplasia-related treatments were collected in a prospective and standardized fashion to allow characterization of the natural history of the disease course in the youngest participants in relation to the level of actual disease burden over time due to treatments, as well as data to support identification of possible risk factors. Data is reported according to the gender of the participants.
Time frame: Baseline to end of study visit (up to 55 months)
Population: Analysis population included all enrolled participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Osteopathic Treatment | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Bilevel Positive Airway Pressure | 4 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Pharyngeal Operation | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Mechanical Ventilation | 3 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Spinal Laminectomy | 2 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Specialist Consultation | 3 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Adenotonsillectomy | 11 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Epiphysiodesis | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Ultrasound Skull | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Ergotherapy | 2 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Psychotherapy | 2 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Hearing Aid User | 3 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Spinal Decompression | 2 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Walking Aid User | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Dental Care | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Magnetic Resonance Imaging | 3 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Middle Ear Operation | 2 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Cervical Spinal Stenosis | 0 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Orthodontic Procedure | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Kyphosis | 0 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Magnetic Resonance Imaging Spinal | 2 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Ventriculo-Peritoneal Shunt | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Hearing Aid Therapy | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Lordosis | 0 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Kinesitherapy | 0 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Maxillofacial Operation | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Laryngoplasty | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Foramen Magnum Stenosis | 0 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Mastoidectomy | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Nasal Irrigation | 0 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Medical Device Removal | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Otitis Media Chronic | 0 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Ear Tube Insertion | 32 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Brain Stem Auditory Evoked Response | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Physiotherapy | 21 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Pharyngeal Reconstruction | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Posterior Fossa Decompression | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Splint Application | 0 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Nasal Operation | 0 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Therapeutic Procedure | 0 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Tongue Tie Operation | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Decompressive Craniectomy | 11 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Tooth Extraction | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Bronchoscopy | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Weight Loss Diet | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Speech Rehabilitation | 13 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Bone Operation | 2 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Audiogram | 3 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Tonsillectomy | 13 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Magnetic Resonance Imaging Brain | 3 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Orthopaedic Insoles | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Magnetic Resonance Imaging Neck | 2 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Electromyogram | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Sleep Study | 3 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Continuous Positive Airway Pressure | 7 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Abdominal X-Ray | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Laryngoscopy | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Acoustic Stimulation Tests Normal | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Ear, Nose And Throat Examination | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Spinal Support | 6 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Adenoidectomy | 26 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Otoacoustic Emissions Test | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Occupational Therapy | 5 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Otoscopy | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Neurological Examination Abnormal | 0 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Skeletal Survey | 0 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Oxygen Therapy | 3 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Sleep Endoscopy | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Ultrasound Scan | 1 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Somatosensory Evoked Potentials | 0 Participants |
| Male (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Myringotomy | 5 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Middle Ear Operation | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Bone Operation | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Ventriculo-Peritoneal Shunt | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Mastoidectomy | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Nasal Operation | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Orthopaedic Insoles | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Pharyngeal Reconstruction | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Posterior Fossa Decompression | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Therapeutic Procedure | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Magnetic Resonance Imaging Spinal | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Acoustic Stimulation Tests Normal | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Brain Stem Auditory Evoked Response | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Bronchoscopy | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Ear, Nose And Throat Examination | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Laryngoscopy | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Hearing Aid User | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Cervical Spinal Stenosis | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Otitis Media Chronic | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Ultrasound Scan | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Ultrasound Skull | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Walking Aid User | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Kyphosis | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Lordosis | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Foramen Magnum Stenosis | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Adenoidectomy | 7 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Physiotherapy | 11 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Decompressive Craniectomy | 11 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Speech Rehabilitation | 9 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Tonsillectomy | 4 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Adenotonsillectomy | 5 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Continuous Positive Airway Pressure | 3 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Spinal Support | 3 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Occupational Therapy | 2 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Oxygen Therapy | 4 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Myringotomy | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Bilevel Positive Airway Pressure | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Mechanical Ventilation | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Specialist Consultation | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Epiphysiodesis | 2 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Ergotherapy | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Psychotherapy | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Spinal Decompression | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Dental Care | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Ear Tube Insertion | 17 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Orthodontic Procedure | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Spinal Laminectomy | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Hearing Aid Therapy | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Kinesitherapy | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Laryngoplasty | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Maxillofacial Operation | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Medical Device Removal | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Nasal Irrigation | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Osteopathic Treatment | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Pharyngeal Operation | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Splint Application | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Tongue Tie Operation | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Tooth Extraction | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Weight Loss Diet | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Magnetic Resonance Imaging | 3 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Audiogram | 2 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Magnetic Resonance Imaging Brain | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Magnetic Resonance Imaging Neck | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Sleep Study | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Abdominal X-Ray | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Electromyogram | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Neurological Examination Abnormal | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Otoacoustic Emissions Test | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Otoscopy | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Skeletal Survey | 1 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Sleep Endoscopy | 0 Participants |
| Female (Aged <2 Years) | Number of Participants With Achondroplasia-Related Treatments | Somatosensory Evoked Potentials | 1 Participants |
Secondary
Baseline and Post-baseline Measurements of Serum Collagen X Marker
Collagen X Marker (CXM), is a degradation by-product of endochondral ossification that is released into the circulation in proportion to overall growth plate activity. This marker corresponds to the rate of linear bone growth at time of measurement as recently demonstrated in children of normal average growth. Data is reported according to age group (\<2 years, 2-10 years, and ≥10 years) and gender of the participants.
Time frame: Baseline, 1 year, 2 years, 3 years
Population: Analysis population included all enrolled participants, among whom, 2 participants have not been included due to missing age. The Overall Number of Participants Analyzed was based on age at baseline. The Number Analyzed in a row was based on actually analyzed participants at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Male (Aged <2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 1 year | 16053 nanogram per liter (ng/L) | Standard Deviation 6025 |
| Male (Aged <2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 2 years | 13757 nanogram per liter (ng/L) | Standard Deviation 3906.2 |
| Male (Aged <2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | Baseline | 20433 nanogram per liter (ng/L) | Standard Deviation 8479.2 |
| Male (Aged <2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 3 years | 13719 nanogram per liter (ng/L) | Standard Deviation 3198.7 |
| Female (Aged <2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 2 years | 17534 nanogram per liter (ng/L) | Standard Deviation 5558 |
| Female (Aged <2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 1 year | 18767 nanogram per liter (ng/L) | Standard Deviation 5128.7 |
| Female (Aged <2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 3 years | 14953 nanogram per liter (ng/L) | Standard Deviation 3227 |
| Female (Aged <2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | Baseline | 20998 nanogram per liter (ng/L) | Standard Deviation 8959.5 |
| Male (Aged ≥2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 2 years | 14046 nanogram per liter (ng/L) | Standard Deviation 4520.1 |
| Male (Aged ≥2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 3 years | 14416 nanogram per liter (ng/L) | Standard Deviation 3943.9 |
| Male (Aged ≥2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | Baseline | 15336 nanogram per liter (ng/L) | Standard Deviation 4360.7 |
| Male (Aged ≥2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 1 year | 15623 nanogram per liter (ng/L) | Standard Deviation 4208.9 |
| Female (Aged ≥2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 3 years | 14088 nanogram per liter (ng/L) | Standard Deviation 4463 |
| Female (Aged ≥2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 1 year | 15820 nanogram per liter (ng/L) | Standard Deviation 4830.7 |
| Female (Aged ≥2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | Baseline | 15516 nanogram per liter (ng/L) | Standard Deviation 5019.8 |
| Female (Aged ≥2 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 2 years | 15172 nanogram per liter (ng/L) | Standard Deviation 4932.6 |
| Male (Aged ≥10 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 3 years | 13597 nanogram per liter (ng/L) | Standard Deviation 6226.5 |
| Male (Aged ≥10 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 1 year | 13815 nanogram per liter (ng/L) | Standard Deviation 4726.9 |
| Male (Aged ≥10 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | Baseline | 11798 nanogram per liter (ng/L) | Standard Deviation 4330 |
| Male (Aged ≥10 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 2 years | 13630 nanogram per liter (ng/L) | Standard Deviation 4404.8 |
| Female (Aged ≥10 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | 1 year | 13343 nanogram per liter (ng/L) | Standard Deviation 4635.4 |
| Female (Aged ≥10 Years) | Baseline and Post-baseline Measurements of Serum Collagen X Marker | Baseline | 14433 nanogram per liter (ng/L) | Standard Deviation 2433.7 |