Growth Disorders Clinical Trial
Official title:
Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray
Bone age assessment in children is based on the interpretation of hand x-ray scans according
to Greulich and Pyle (GP) standard atlas and frequently used for evaluating growth and
puberty in children and adolescents.
To address the disadvantage of repeated irradiation, the need for specialized radiation
centers, heavy equipment and subjective reading a new device, SonicBone was developed.
SonicBone utilizes a quantitative ultrasonographic technology of ultrasonic (US) waves,
propagating along a measured bone distance. The aim of the study is to evaluate an ultrasound
based device, SonicBone, compared to the current method in children. The investigators will
be compared the US assessment to available bone age X-ray that exists in the medical files of
the patients. The investigators will not do bone age X-ray scans especially for the current
study.
Bone age assessment in children is based on the interpretation of hand x-ray scans according
to Greulich and Pyle standard atlas and frequently used for evaluating growth and puberty in
children and adolescents.
To address the disadvantage of repeated irradiation, the need for specialized radiation
centers, heavy equipment and subjective reading a new device, SonicBone was developed.
SonicBone utilizes a quantitative ultrasonographic technology of ultrasonic (US) waves,
propagating along a measured bone distance. The aim of the study is to evaluate the
ultrasound based device, SonicBone, and to compare it to the current method used in children.
The SonicBone device (Rishon Lezion, Israel) is a small (50cm X 25cm X 25cm), portable, bone
sonometer, which measures two parameters:
1. speed of propagation through bone (speed-of-sound, SOS, m/sec) of inaudible high
frequency waves of a short ultrasound pulse; and
2. attenuation (ATN; the decay rate) of the sound wave by the bone as a function of the
distance it travels between a transmitter probe and a receiver probe15. The hand is
measured by: 1- wrist (W), measuring SOS and ATN at the distal radius and ulna secondary
ossification centers of the epiphyses; 2-metacarpals (MC), measuring SOS and ATN at the
distal metacarpal epiphyses; and 3- phalange (P), measuring SOS and ATN along the bent
proximal third phalanx shaft, growth plate and epiphysis. The average of those 3
readings is define as the child's bone age by SonicBone. All ultrasonic examinations
will be conducted at the Pediatric Endocrinology Clinic, by a trained technician.
X-ray scans will be evaluated independently by a pediatric endocrinologist according to the
GP atlas.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01376921 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Spain
|
N/A | |
| Completed |
NCT01400997 -
Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Czech Republic
|
N/A | |
| Completed |
NCT05244785 -
Health and Nutrition Survey on Shenzhen Children
|
||
| Completed |
NCT00097539 -
A Postmarketing Surveillance Program for Nutropin, Nutropin AQ, and Protropin
|
Phase 4 | |
| Not yet recruiting |
NCT04576845 -
The Effect of Early Childhood Cow's Milk Allergy Elimination Diet on Eating Behaviors, Nutrition, and Growth Status
|
||
| Not yet recruiting |
NCT05056285 -
Pattern of Growth and Characteristics of Down Syndrome Pediatrics Patients
|
||
| Completed |
NCT01263457 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in the UK
|
||
| Terminated |
NCT00330668 -
Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency
|
Phase 3 | |
| Completed |
NCT00378859 -
The Effect of Milk and Meat on IGFs in Prepubertal Boys
|
N/A | |
| Not yet recruiting |
NCT05577130 -
Growth Pattern and Characteristics of Cardiac Pediatric Patients
|
||
| Recruiting |
NCT05033119 -
PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics
|
||
| Completed |
NCT01402999 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Hungary
|
N/A | |
| Completed |
NCT01267526 -
A Canadian, Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Pediatric Subjects Using SAIZEN® Via Easypod™ Auto-injector for Growth Hormone Treatment
|
N/A | |
| Completed |
NCT00139451 -
Nutrients and Hormones: Effects in Boys With Disordered Growth
|
Phase 2 | |
| Terminated |
NCT03274973 -
Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner Syndrome
|
||
| Completed |
NCT02015286 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Middle East
|
N/A | |
| Completed |
NCT01582334 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Argentina
|
N/A | |
| Completed |
NCT01439061 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy
|
N/A | |
| Completed |
NCT00125164 -
Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
|
Phase 3 | |
| Completed |
NCT00174408 -
Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age
|
Phase 3 |