Effects of once-weekly sustained-release growth hormone: A double-blind, placebo-controlled study in adult growth hormone deficiency

Journal of Clinical Endocrinology and Metabolism

Volumn 96, Issue 6, 2011, Pages 1718-1726

  Biller, Beverly M K ^a   Ji, Hyi Jeong ^b   Ahn, Hyunji ^b   Savoy, Conrad ^c   Siepl, E Christine ^c   Popovic, Vera ^d   Coculescu, Mihail ^e   Roemmler, Josefine ^f   Gavrila, Catalin ^g   Cook, David M ^h   Strasburger, Christian J ⁱ  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b LG Chemical Ltd   (South Korea)

^c Biopartners GmbH   (Switzerland)

^d Institute of Endocrinology   (Serbia)

^e C I PARHON NATIONAL INSTITUTE OF ENDOCRINOLOGY   (Romania)

^f UNIVERSITY OF MUNICH   (Germany)

^g SANA Medical Center   (Romania)

^h OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

ⁱ CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY; GLUCOSE; LB 03002; PLACEBO; RECOMBINANT GROWTH HORMONE; SOMATOMEDIN C; UNCLASSIFIED DRUG;

ADULT; ARTHRALGIA; ARTICLE; BACKACHE; BODY COMPOSITION; CARPAL TUNNEL SYNDROME; CONTROLLED STUDY; COUGHING; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; DUAL ENERGY X RAY ABSORPTIOMETRY; FEMALE; GLUCOSE HOMEOSTASIS; GROWTH HORMONE DEFICIENCY; HUMAN; INJECTION SITE REACTION; INJURY; INTRACRANIAL TUMOR; LARYNX PAIN; LIMB PAIN; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; METABOLIC DISORDER; NEUROFIBROMA; NUTRITIONAL DISORDER; PARESTHESIA; PERIPHERAL EDEMA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RHINOPHARYNGITIS; SIDE EFFECT; SKIN DISEASE; SORE THROAT; THORAX DISEASE; THROMBOPHLEBITIS; VASCULAR DISEASE; VOMITING;

ABSORPTIOMETRY, PHOTON; ADIPOSE TISSUE; ADULT; ANALYSIS OF VARIANCE; BODY COMPOSITION; DELAYED-ACTION PREPARATIONS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DWARFISM, PITUITARY; FEMALE; HORMONE REPLACEMENT THERAPY; HUMAN GROWTH HORMONE; HUMANS; INSULIN-LIKE GROWTH FACTOR I; MALE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 79956329658     PISSN: 0021972X     EISSN: 0021972X     Source Type: Journal    
DOI: 10.1210/jc.2010-2819     Document Type: Article

References (21)

1. Rosenfeld RG, Bakker B 2008 Compliance and persistence in pediatric and adult patients receiving growth hormone therapy. Endocr Pract 14:143-154
2. Osterberg L, Blaschke T 2005 Adherence to medication. N Engl J Med 353:487-497 (Pubitemid 41127293)
3. Laursen T, Gravholt CH, Heickendorff L, Drustrup J, Kappelgaard AM, Jørgensen JO, Christiansen JS 2001 Long-term effects of continuous subcutaneous infusion versus daily subcutaneous injections of growth hormone (GH) on the insulin-like growth factor system, insulin sensitivity, body composition, and bone and lipoprotein metabolism in GH-deficient adults. J Clin Endocrinol Metab 86:1222-1228 (Pubitemid 32323008)
4. Reiter EO, Attie KM, Moshang Jr T, Silverman BL, Kemp SE, Neuwirth RB, Ford KM, Saenger P; Genentech Inc.-Alkermes Inc. Collaborative Study Group 2001 A multicenter study of the efficacy and safety of sustained release GH in the treatment of naive pediatric patients with GH deficiency. J Clin Endocrinol Metab 86:4700-4706 (Pubitemid 33020508)
5. Cook DM, Biller BM, Vance ML, Hoffman AR, Phillips LS, Ford KM, Benziger DP, Illeperuma A, Blethen SL, Attie KM, Dao LN, Reimann JD, Fielder PJ 2002 The pharmacokinetic and pharmacodynamic characteristics of a long-acting growth hormone (GH) preparation (Nutropin depot) in GH-deficient adults. J Clin Endocrinol Metab 87:4508-4514 (Pubitemid 35251858)
6. Harris PE, Didier E, Boonen A, Kantaridis C, Weissgerber G, Abs R 2006 The pharmacokinetics, pharmacodynamics and safety of pegylated recombinant human growth hormone after single subcutaneous injection in adult male patients with growth hormone deficiency. Horm Res 65(Suppl 4):148
7. Clemmons DR 2007 Long-acting forms of growth hormone-releasing hormone and growth hormone: effects in normal volunteers and adults with growth hormone deficiency. Horm Res 68(Suppl 5):178-181
8. Hoffman AR, Biller BM, Cook D, Baptista J, Silverman BL, Dao L, Attie KM, Fielder P, Maneatis T, Lippe B 2005 Efficacy of a long-acting growth hormone (GH) preparation in patients with adult GH deficiency. J Clin Endocrinol Metab 90:6431-6440 (Pubitemid 41759296)
9. Peter F, Savoy C, Ji HJ, Juhasz M, Bidlingmaier M, Saenger P 2009 Pharmacokinetic and pharmacodynamic profile of a new sustained release GH formulation, LB03002, in children with GH deficiency. Eur J Endocrinol 160:349-355
10. Bidlingmaier M, Kim J, Savoy C, Kim MJ, Ebrecht N, de la Motte S, Strasburger CJ 2006 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 91:2926-2930 (Pubitemid 44271737)
11. Cook DM, Ludlam WH, Cook MB 1999 Route of estrogen administration helps to determine growth hormone (GH) replacement dose in GH-deficient adults. J Clin Endocrinol Metab 84:3956-3960 (Pubitemid 30644180)
12. Johannsson G, Rosen T, Bengtsson BA 1997 Individualized dose titration of growth hormone (GH) during GH replacement in hypopituitary adults. Clin Endocrinol (Oxf) 47:571-581 (Pubitemid 27496332)
13. Drake WM, Coyte D, Camacho-Hübner C, Jivanji NM, Kaltsas G, Wood DF, Trainer PJ, Grossman AB, Besser GM, Monson JP 1998 Optimizing growth hormone replacement therapy by dose titration in hypopituitary adults. J Clin Endocrinol Metab 83:3913-3919 (Pubitemid 28513572)
14. Janssen YJ, Frölich M, Roelfsema F 1997 A low starting dose of genotropin in growth hormone-deficient adults. J Clin Endocrinol Metab 82:129-135 (Pubitemid 27021283)
15. de Boer H, Blok GJ, Voerman B, de Vries P, Popp-Snijders C, van der Veen E 1995 The optimal growth hormone replacement dose in adults, derived from bioimpedance analysis. J Clin Endocrinol Metab 80:2069-2076
16. Ekman B, Lindström T, Nyström F, Olsson AG, Toss G, Arnqvist HJ 2002 A dose titration model for recombinant GH substitution aiming at normal plasma concentrations of IGF-I in hypopituitary adults. Eur J Endocrinol 147:49-57 (Pubitemid 34814739)
17. Gharib H, Cook DM, Saenger PH, Bengtsson BA, Feld S, Nippoldt TB, Rodbard HW, Seibel JA, Vance ML, Zimmerman D; American Association of Clinical Endocrinologists 2003 American Association of Clinical Endocrinologists medical guidelines for clinical practice for growth hormone use in adults and children 2003 update. Endocr Pract 9:64-76
18. Filipsson H, Johannsson G 2009 GH replacement in adults: interactions with other pituitary hormone deficiencies and replacement therapies. Eur J Endocrinol 161(Suppl 1):S85-S95
19. Peterkova V, Arslanoglu I, Bolshova-Zubkovskaya E, Romer T, Zdravkovic D, Kratzsch J, Ji HJ, Savoy C, Saenger P 2007 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 68:288-293 (Pubitemid 350059702)
20. Riente L, Chimenti D, Pratesi F, Delle Sedie A, Tommasi S, Tommasi C, Bombardieri S, Migliorini P 2004 Antibodies to tissue transglutaminase and Saccharomyces cerevisiae in ankylosing spondylitis and psoriatic arthritis. J Rheumatol 31:920-924 (Pubitemid 38585815)
21. Walker LJ, Aldhous MC, Drummond HE, Smith BR, Nimmo ER, Arnott ID, Satsangi J 2004 Anti-Saccharomyces cerevisiae antibodies (ASCA) in Crohn's disease are associated with disease severity but not NOD2/CARD15 mutations. Clin Exp Immunol 135:490-496 (Pubitemid 38297152)