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Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients with Extreme Short Stature Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients with Extreme Short Stature conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients with Extreme Short Stature Clinical research trials and Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients with Extreme Short Stature medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients with Extreme Short Stature. Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients with Extreme Short Stature Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients with Extreme Short Stature clinical trial. Subjects often receive the most expert healthcare possible for their Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients with Extreme Short Stature condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients with Extreme Short Stature  Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients with Extreme Short Stature
Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients with Extreme Short Stature
For Condition: Dwarfism,Growth Disorder
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: Children with extreme short stature (height) and their families often experience significant psychological stress related to concerns about adult height. In addition, short stature often results in life-long emotional, social, and physical obstacles to the affected person. Normal growth occurs in two phases. The first phase, known as childhood growth, occurs below the age of 10. The second phase of growth, teen-age or adolescent growth, begins between the ages of 10 and 15. In addition, puberty marks the time when the bone's growth plates (epiphysis) begin to close, initiating the completion of linear growth (height). Some children suffer from a condition called precocious puberty, meaning that puberty begins at a younger age than normal. The development of medications known as synthetic LHRH analogs have provided a method to delay puberty and treat these patients. LHRHa (deslorelin) is a hormone created to act like naturally occurring LHRH. It been used in patient's diagnosed with precocious (early onset) puberty. The drugs were able to regress patient's clinical signs of puberty, decrease the levels of adult sex hormones produced, and slow the rate of bone aging.
Details: Children with extreme short stature and their families frequently experience significant psychological stress related to concerns about adult height. Additionally, extreme short stature often presents life-long emotional, social, and physical obstacles to the affected individual. The onset of puberty in such patients presents a critical management problem because puberty initiates the process of epiphyseal closure that terminates linear growth. Until recently, there was no way to delay the onset of puberty in such patients. The development of synthetic LHRH analogs, however, has provided such a method. Administration of such analogs to children with precocious puberty caused a regression of their clinical signs of puberty, a decrease in their gonadotropins and sex steroids, and a slowing of the rate of bone age advancement. We propose to treat pubertal children with extreme short stature with a long-acting analog of luteinizing hormone-releasing hormone (D-Trp6-Pro9-NEt-LHRHa). The goal of LHRHa treatment in these children is to halt the normal progression into puberty and thereby delay epiphyseal fusion. We postulate that delay of puberty will prolong pre-pubertal growth prior to the pubertal spurt and subsequent epiphyseal fusion, and thus will enhance ultimate height. This study will test this hypothesis through a double-blind, randomized comparison of the effect of LHRHa and placebo on final adult height. Patients will be treated with LHRHa or placebo for 4 years, and will then be followed until they have completed puberty and have stopped growing.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients with extreme short stature will qualify for inclusion under this protocol if they meet the following criteria: Age 9 through 15.99 years at the start of treatment. Tanner II-V pubertal development. Height at least 2.25 S.D. below the median for chronologic age at the time of pubertal onset, or a predicted adult height at least 2.25 S.D. below median adult height. The height criterion must be met before study entry, but not necessarily on the actual date the patient starts to take the protocol injections because advancing puberty may cause an increase in height velocity that temporarily increases height standard deviation score. Unfused carpal and phalangeal epiphyses by bone age x-ray.
Total Enrollment: 50
Location and Contact Information:
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 830199; 83-CH-0199
Study Start Date: November 14, 1983
Record last reviewed: October 31, 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001190
Other Growth Disorder Studies:
1. Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients with Extreme Short Stature
2. Issues Surrounding Prenatal Genetic Testing for Achondroplasia
3. Growth Hormone Therapy in Osteogenesis Imperfecta
4. Study of Skeletal Disorders and Short Stature
5. The Effects of Hormones in Growth Hormone-Treated Girls with Turner Syndrome
Related Studies:
Other Growth Disorder Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients with Extreme Short Stature
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