Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients With Extreme Short Stature

NCT00001190 | Completed Phase 2

• 2 other identifiers: 83019983-CH-0199
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dwarfism; Growth Disorder

Keywords

Growth; Adolescence; Children

Interventions

Deslorelin DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institute of Child Health and Human Development (NICHD)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Municchi G, Rose SR, Pescovitz OH, Barnes KM, Cassorla FG, Cutler GB Jr. Effect of deslorelin-induced pubertal delay on the growth of adolescents with short stature and normally timed puberty: preliminary results. J Clin Endocrinol Metab. 1993 Nov;77(5):1334-9. doi: 10.1210/jcem.77.5.8077329.

  PMID: 8077329 BACKGROUND

• Manasco PK, Pescovitz OH, Hill SC, Jones JM, Barnes KM, Hench KD, Loriaux DL, Cutler GB Jr. Six-year results of luteinizing hormone releasing hormone (LHRH) agonist treatment in children with LHRH-dependent precocious puberty. J Pediatr. 1989 Jul;115(1):105-8. doi: 10.1016/s0022-3476(89)80341-5. No abstract available.

  PMID: 2661787 BACKGROUND

• Bourguignon JP. Linear growth as a function of age at onset of puberty and sex steroid dosage: therapeutic implications. Endocr Rev. 1988 Nov;9(4):467-88. doi: 10.1210/edrv-9-4-467. No abstract available.

  PMID: 3065075 BACKGROUND

MeSH Terms

Conditions

Dwarfism; Growth Disorders

Interventions

deslorelin

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: May 22, 2002
• Study Start: November 1, 1983
• Study Completion: October 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2001-10

Locations

US (1)