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Short Stature clinical trials

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NCT ID: NCT03575221 Completed - Clinical trials for Osteogenesis Imperfecta

Natural History of the Collagen-Related Disorder Osteogenesis Imperfecta and Genotype Phenotype Correlation

Start date: July 30, 2018
Phase:
Study type: Observational

Background: Osteogenesis Imperfecta (OI) is a connective tissue disorder. OI affects many aspects of a person s health and growth. It can cause frequent fractures, short stature, and bowing of the long bones. There is no known cure for OI so researchers want to learn more about it. Objectives: To obtain a natural history of the course of OI. To find changes in genes that affect the disease. Eligibility: People from birth to age 12 years with certain types of OI People who previously had childhood data collected in certain other protocols Design: Participants will stay in the clinic for a few days each visit. Visits will be about every 3-4 months to age 5 then about every 6-12 months. Visits may include: Medical history Physical exam Hearing test Dental exam Blood, urine, and heart tests Breathing measured while wearing a clear plastic hood for about 30 minutes Tests of motion, strength, and motor skills X-rays of the left hand, chest, legs, and spine Bone density scan. Participants will lie on a flat table while a very small dose of x-rays is passed through the body. Computed tomography and magnetic resonance imaging scans. Participants will lie on an exam table that moves in and out a scanner. Breathing tests using stickers on the chest, a light probe on a finger or foot, and a face mask Ultrasound of the kidneys, ureters, and bladder Questionnaires A small section of skin removed from the arm or thigh For some tests, participants may take medicine to make them sleepy. Participants may give separate consent for photos to be taken.

NCT ID: NCT03323177 Withdrawn - Growth Disorders Clinical Trials

Long Term Effects of Nutritional Supplementation on Final Height

Start date: June 2018
Phase: N/A
Study type: Interventional

The proposed study is an extension study to two ongoing double blind, randomized, placebo-controlled studies evaluating the effect of gender-specific nutritional supplementation on growth of short and lean adolescent boys and girls. The aim of the current study is to extend these short term double blind, randomized, placebo controlled studies (one in boys and one in girls) and to add an extension study, which will evaluate the long term effect of the gender specific nutritional supplementation on final height. Patients completing the ongoing studies will be offered to continue treatment with the study formula until final height. Patients reluctant to continue to consume the study formula will be offered to continue followup only during the extension study without any intervention.

NCT ID: NCT03288103 Completed - Short Stature Clinical Trials

Growth Hormone Treatment in Patients With Aggrecan (ACAN) Deficiency

Start date: February 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, single-arm prospective pilot study to study the effects of a single dose regimen of daily growth hormone medication (Norditropin) on pre-pubertal children with Aggrecan deficiency. The growth response will be tracked over a 12 month period. A protocol extension has been approved to continue subjects on treatment for an additional 2 years.

NCT ID: NCT03123003 Recruiting - Growth Disorders Clinical Trials

Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02879747 Completed - Short Stature Clinical Trials

Individualizing Dose of Growth Hormone to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children

MAINTENANCE
Start date: December 2003
Phase: Phase 2/Phase 3
Study type: Interventional

The objective was to study whether normal growth velocity can be maintained with adapted GH dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled catch up growth (=difference to target height reached, less than - 0.6 SDS).

NCT ID: NCT02826902 Completed - Osteoarthritis Clinical Trials

Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial

Start date: September 27, 2016
Phase: N/A
Study type: Interventional

The effect of total intravenous anesthesia (TIVA) versus inhalational anesthesia on the quality of recovery from surgery has been reported in several different types of operations. The Quality of Recovery 40 (QoR-40) questionnaire is designed multi-dimensionally to assess the degree of recovery after anesthesia and surgery, and has been validated in previous studies. The present study aims to compare the quality of recovery with the QoR-40 questionnaire, in patients undergoing correctional tibial osteotomy under general anesthesia with either TIVA with propofol or inhalational anesthesia with desflurane.

NCT ID: NCT02636270 Completed - Short Stature Clinical Trials

IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency

Start date: December 21, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

With this study we want to investigate the pharmacokinetic (PK) effect of a single injection of rhIGF-1 in patients with PAPP-A2 mutations compared to heterozygous carriers and healthy controls. This will be followed by treatment of PAPP-A2 deficient patients with IGF-1 for a period of one-year to assess growth velocity. Additionally, we want to further describe the phenotypic characteristics of patients with PAPP-A2 deficiency.

NCT ID: NCT02389803 Completed - Short Stature Clinical Trials

Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys

Start date: June 2015
Phase: N/A
Study type: Interventional

Study design: Double blind, randomized, placebo controlled study. Participants will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1. The primary objective of the study is to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on weight Standard Deviation Score (SDS) and height SDS The Secondary Objectives of the study are to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on BMI SDS, growth velocity, time to puberty, quality of life and self-esteem The study will continue for 6 months of intervention versus active placebo, with additional optional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the study supplement. All analyses of the effect's on primary and secondary outcome measurements will take into account the consumption rate of the study formula/placebo

NCT ID: NCT02311322 Terminated - Short Stature Clinical Trials

Genetic Causes of Growth Disorders

Start date: December 2, 2014
Phase:
Study type: Observational

Background: - Some growth disorders are caused by a change in genes. Genes are the instructions the body uses to function. Changes in genes often cause them not to work correctly. Researchers want to use a new technology called exome sequencing, to look at many genes at once. This is done by looking at DNA from blood or saliva in a lab. This method may help find the cause of disorders that researchers haven t been able to find using past methods. Objectives: - To better understand genetic causes of growth disorders. Eligibility: - Children and adults with growth disorders and their family members. Design: - Participants will give a small sample of blood and/or saliva. - Researchers will purify DNA from the sample. They will perform exome sequencing and other tests to look for changes in genes. Some participants may receive limited or no genetic tests. Researchers will let them know if exome sequencing is performed. - Participants may have a medical history, physical exam, and lab tests. They may have x-rays or ultrasound tests to study the disorder in their family. - Some participants may be recommended for a specific genetic test from a commercial lab. They may have to pay for that test. - Participants will be told about test results that relate to the growth disorder. This may happen up to years after the testing. They may have to give another blood and/or saliva sample. - Some participants may get results about other health conditions. This will only happen if the information would help the person or their family protect their health. They may have to give another blood and/or saliva sample.

NCT ID: NCT02137538 Completed - Short Stature Clinical Trials

Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole

Start date: November 18, 2009
Phase: Phase 4
Study type: Interventional

The purpose of the study is to determine if there are differences in the final height or hormone profile of short pubertal boys placed on different forms of aromatase inhibitor now routinely used to increase stature: Anastrozole and Letrozole. It also should determine if there are differences in the side effect profiles of the two drugs to be used.