Effects of two different GH doses in children with growth hormone deficiency

Completed

• Conditions: growth hormone deficiency, growth hormone treatment, dose response study

• Registration Number: NL-OMON29520
• Lead Sponsor: ovo Nordisk A/S Denmark

Brief Summary

de Muinck Keizer-Schrama SM, Rikken B, Wynne HJ, Hokken-Koelega AC, Wit JM, Bot A, Drop SL 1992 Dose-response study of biosynthetic human growth hormone (GH) in GH-deficient children: effects on auxological and biochemical parameters. Dutch Growth Hormone Working Group. J Clin Endocrinol Metab74:898-905<br><br> - De Muinck Keizer-Schrama S, Rikken B, Hokken-Koelega A, Wit JM, Drop S 1994 Comparative effect of two doses of growth hormone for growth hormone deficiency. The Dutch Growth Hormone Working Group. Arch Dis Child 71:12-18

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

1. Documented GHD of organic or idiopathic origin, including isolated GHD as well as multiple pituitary hormone deficiencies;

2. BA < 12 for boys and < 10 yr for girls, determined according to the procedure of Tanner and Whitehouse, 20 bones (TW2-20)

Exclusion Criteria

1. Growth retardation due to diabetes mellitus, inborn error of metabolism, primary bone disease, disorders of cardiopulmonary, gastrointestinal, genitourinary, or nervous tracts, or serious suspicion of psychosocial dwarfism;

2. Any kind of drug that might interfere with GH therapy, with the exception of replacement doses of T4 and/or hydrocortisone in multiple hormone deficiencies;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Adult height; attained AH minus target height (TH)

Secondary Outcome Measures

Name	Time	Method
- Adverse events <br /><br>- Timing of puberty<br /><br>- Bone maturation