Observational Study Investigating Clinical & Anthropometric Characteristics of Children With Achondroplasia.

Age Range:Any - 10
Start Date:June 15, 2018
End Date:June 15, 2023
Contact:Alison Slade
Phone:+41 61 551 3030

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A Multi-center, Prospective, Longitudinal, Observational Study to Investigate the Clinical and Anthropometric Characteristics of Children With the Diagnosis Achondroplasia.

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.

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 /

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

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
We found this trial at
1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
Wilmington, DE
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10 Wilrijkstraat
Antwerp, 2650
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Baltimore, Maryland 21287
Baltimore, MD
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
Boston, MA
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50 North Medical Drive
Salt Lake City, Utah 84132
Salt Lake City, UT
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