24-month use of once-weekly GH, LB03002, in prepubertal children with GH deficiency

Journal of Clinical Endocrinology and Metabolism

Volumn 99, Issue 1, 2014, Pages 126-132

  Khadilkar, Vaman ^a   Radjuk, Klavdia A ^b   Bolshova, Elena ^c   Khadgawat, Rajesh ^d   El Kholy, Mohamed ^e   Desai, Meena ^f   Peterkova, Valentina ^g   Mericq, Veronica ^h   Kratzsch, Jürgen ⁱ   Siepl, E Christine ^j   Martin, Dieter ^j   Lopez, Prema ^j   Ji, Hyi Jeong ^k   Bae, Yoon Ju ^k   Lee, Jin Hwa ^k   Saenger, Paul H ^l  

^a JEHANGIR HOSPITAL   (India)

^b Second Children's Hospital   (Belarus)

^c STATE INSTITUTION NATIONAL RESEARCH CENTER FOR RADIATION MEDICINE OF THE NATIONAL ACADEMY OF MEDICAL SCIENCES OF UKRAINE   (Ukraine)

^d ALL INDIA INSTITUTE OF MEDICAL SCIENCES   (India)

^e AIN SHAMS UNIVERSITY   (Egypt)

^f Sir Hurkisondas Nurrotumdas Hospital & Research Centre   (India)

^g INSTITUTE OF BIOMEDICAL CHEMISTRY   (Russian Federation)

^h Institute of Maternal and Child Research   (Chile)

ⁱ Institute of Laboratory Medicine   (Germany)

^j BioPartners GmbH   (Switzerland)

^k LG Chemical Ltd   (South Korea)

^l STONY BROOK UNIVERSITY   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN GROWTH HORMONE; SOMATOMEDIN BINDING PROTEIN 3; SOMATOMEDIN C;

ANALYSIS OF COVARIANCE; ARTICLE; BONE GROWTH; BONE MATURATION; CHEMOLUMINESCENCE; CHILD; CONTROLLED STUDY; DOSAGE SCHEDULE COMPARISON; DRUG EFFICACY; DRUG SAFETY; FEMALE; GROWTH HORMONE DEFICIENCY; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PREPUBERTY; PRESCHOOL CHILD; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SEX DIFFERENCE; SUSTAINED RELEASE FORMULATION; TREATMENT DURATION; TREATMENT RESPONSE;

ANTIBODIES; BODY HEIGHT; CHILD; CHILD, PRESCHOOL; DELAYED-ACTION PREPARATIONS; DRUG ADMINISTRATION SCHEDULE; FEMALE; GROWTH DISORDERS; HUMAN GROWTH HORMONE; HUMANS; MALE; PUBERTY; TIME FACTORS;

EID: 84892176292     PISSN: 0021972X     EISSN: 19457197     Source Type: Journal    
DOI: 10.1210/jc.2013-2502     Document Type: Article

References (22)

1. Rosenfeld RG, Bakker B. Compliance and persistence in pediatric and adult patients receiving growth hormone therapy. Endocr Pract. 2008;14:143-154.
2. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353:487-497.
3. Kruk ME, Schwalbe N. The relation between intermittent dosing and adherence: preliminary insights. Clin Ther. 2006;28:1989-1995.
4. Cutfield WS, Derraik JG, Gunn AJ, et al. Non-compliance with growth hormone treatment in children iscommonand impairs linear growth. PLoS One. 2011;6:e16223.
5. Fisher BG, Acerini CL. Understanding the growth hormone therapy adherence paradigm: a systematic review. Horm Res Paediatr. 2013; 79:189-196.
6. Polonsky WH, Fisher L, Hessler D, Bruhn D, Best JH. Patient perspectives on once-weekly medications for diabetes. Diabetes Obes Metab. 2011;13:144-149.
7. Peterkova V, Arslanoglu I, Bolshova-Zubkovskaya E, et al. A randomized, double-blind study to assess the efficacy and safety of valtropin, a biosimilar growth hormone, in children with growth hormone deficiency. Horm Res. 2007;68:288-293.
8. Peter F, Savoy C, Ji HJ, Juhasz M, Bidlingmaier M, Saenger P. Pharmacokinetic and pharmacodynamic profile of a new sustained-release GH formulation, LB03002, in children with GH deficiency. Eur J Endocrinol. 2009;160:349-355.
9. Bidlingmaier M, Kim J, Savoy C, et al. Comparative pharmacokinetics and pharmacodynamics of a new sustained-release growth hormone (GH), LB03002, versus daily GH in adults with GH deficiency. J Clin Endocrinol Metab. 2006;91:2926-2930.
10. Péter F, Bidlingmaier M, Savoy C, Ji HJ, Saenger PH. Three-year efficacy and safety of LB03002, a once-weekly sustained-release growth hormone (GH) preparation, in prepubertal children with GH deficiency (GHD). J Clin Endocrinol Metab. 2012;97:400-407.
11. Biller BM, Ji HJ, Ahn H, et al. Effects of once-weekly sustainedrelease growth hormone: a double-blind, placebo-controlled study in adult growth hormone deficiency. J Clin Endocrinol Metab. 2011; 96:1718-1726.
12. Kuczmarski RJ, Ogden CL, Guo SS, et al. 2000 CDC growth charts for the United States: methods and development. Vital Health Stat 11. 2002;246:1-190.
13. Prader A, Largo RH, Molinari L, Issler C. Physical growth of Swiss children from birth to 20 years of age. First Zurich longitudinal study of growth and development. Helv Paediatr Acta Suppl. 1989; 52:1-125.
14. Greulich W, Pyle S. Radiographic Atlas of Skeletal Development of the Hand and Wrist. Palo Alto, CA: Stanford University; 1959.
15. Roche AF, Wainer H, Thissen D. The RWT method for the prediction of adult stature. Pediatrics. 1975;56:1027-1033.
16. Elmlinger MW, Kühnel W, Weber MM, Ranke MB. Reference ranges for two automated chemiluminescent assays for serum insulin- like growth factor I (IGF-I) and IGF-binding protein 3 (IGFBP-3). Clin Chem Lab Med. 2004;42:654-664.
17. Hwang JS, Lee HS, Chung WY, et al. Efficacy and safety of LB03002, a once-weekly sustained-releasehuman GH for 12-month treatment in Korean children with GH deficiency. Eur J Endocrinol. 2013;169:179-185.
18. Ranke MB, Lindberg A; KIGS International Board. Observed and predicted growth responses in prepubertal children with growth disorders: guidance of growth hormone treatment by empirical variables. J Clin Endocrinol Metab. 2010;95:1229-1237.
19. Ranke MB, Guilbaud O. Growth response in prepubertal children with idiopathic growth hormone deficiency during the first two years of treatment with human growth hormone. Analysis of the Kabi Pharmacia International Growth Study. Acta Paediatr Scand Suppl. 1991;379:109-115.
20. de Wit CC, Sas TC, Wit JM, Cutfield WS. Patterns of catch-up growth. J Pediatr. 2013;162:415-420.
21. Boersma B, Wit JM. Catch-up growth. Endocr Rev. 1997;18:646-661.
22. Mullis PE. Genetic control of growth. Eur J Endocrinol. 2005;152:11-31.