EXCLUDED STUDIES

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Somatropin (Genotropin) (0.15 mg/day to 0.3 mg/day): Replacement of Endogenous Growth Hormone in Adults with Growth Hormone Deficiency [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Jan.

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Somatropin (Genotropin) (0.15 mg/day to 0.3 mg/day): Replacement of Endogenous Growth Hormone in Adults with Growth Hormone Deficiency [Internet].

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APPENDIX 3EXCLUDED STUDIES

Inappropriate Comparator

1.: Clinical study report: TRN 91-081-01. The effect of somatropin (Genotropin^®) replacement therapy in GH-deficient adults on body composition, quality of life, bone mineral density, respiratory muscle strength, serum lipids, immune function, serum IGF-1 and safety [CONFIDENTIAL internal manufacturer's report]. Stockholm: Kabi Pharmacia AB; Jan 14, 1993.
2.: Clinical study report: TRN 91-081-02. The effect of somatropin (Genotropin^®) replacement therapy in GH-deficient adults on body composition, quality of life, bone mineral density, cardiovascular function, serum lipids, coagulation factors, serum IGF-1, insulin sensitivity and safety. A final report of randomized, double-blind, placebo-controlled study. [CONFIDENTIAL internal manufacturer's report]. Stockholm: Kabi Pharmacia AB; Oct 20, 1993.
3.: Clinical study report: TRN 91-131-04. The effect of somatropin (Genotropin^®) replacement therapy in GH-deficient adults on body composition, bone mineral content, bone mineral density, serum IGF-1, serum IGFBP-3 and safety. A final report of a randomized, double blind, placebo-controlled study [CONFIDENTIAL internal manufacturer's report]. Stockholm: Pharmacia AB; Aug 30, 1996.
4.: Clinical study report TRN 91-131-08. The effect of somatropin (Genotropin^®) replacement therapy in GH-deficient adults on body composition, quality of life, bone mineral density, serum IGF-1, exercise and safety. A final report of a randomized, double blind, placebo-controlled study (6 months) followed by open somatropin replacement (6 months) [CONFIDENTIAL internal manufacturer's report]. Stockholm: Pharmacia AB; Jan 31, 1996.
5.: Clinical study report: CTN 92-8124-011. The effect of somatropin (Genotropin^®) replacement therapy in GH-deficient adults on body composition, hand grip strength, quality of life, serum IGF-1, lipid metabolism and safety [CONFIDENTIAL internal manufacturer's report]. Stockholm: Pharmacia AB; Mar 12, 1996.
6.: Clinical study report:TRN 91-001. The effect of somatropin (Genotropin) replacement therapy in growth hormone deficiency adults on body composition, quality of life, bone mineral density, muscle strength, exercise capacity, serum IGF-1, plasma lipids and safety. A report of a randomised, double-blind, 6-month placebo-controlled study and 24-month somatropin replacement therapy [CONFIDENTIAL internal manufacturer's report]. Stockholm: Pharmacia & Upjohn AB; Jun 18, 1997.
7.: Beauregard C, et al. J Clin Endocrinol Metab [Internet] 2008;93(6):2063–2071. [cited 2013 Aug 8]; Available from: http://jcem.endojournals.org/content/93/6/2063.full.pdf+html. [PMC free article: PMC2435650] [PubMed: 18381581]
8.: Beauville M, et al. American Journal of Physiology - Endocrinology and Metabolism. 1992;263(3 26-3):E467–E472. [PubMed: 1415526]
9.: Bollerslev J, et al. Eur J Endocrinol. 2006;154(4):537–543. [cited 2013 Aug 9]; [PubMed: 16556716]
10.: Bramnert M, et al. J Clin Endocrinol Metab [Internet] 2003 Apr;88(4):1455–1463. [cited 2013 Aug 12]; Available from: http://jcem.endojournals.org/content/88/4/1455.full.pdf+html. [PubMed: 12679422]
11.: Carroll PV, et al. Eur J Endocrinol. 1997;137(2):146–153. [PubMed: 9272102]
12.: Cheung NW, et al. J Clin Endocrinol Metab. 1996;81(5):1999–2001. [PubMed: 8626872]
13.: Chihara K, et al. Growth Horm IGF Res. 2006 Apr;16(2):132–142. [PubMed: 16702006]
14.: Christ ER, et al. J Clin Endocrinol Metab [Internet] 1999;84(1):307–316. [cited 2013 Aug 8]; Available from: http://jcem.endojournals.org/content/84/1/307.full.pdf+html. [PubMed: 9920100]
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16.: Cuneo RC, et al. J Clin Endocrinol Metab [Internet] 1998;83(1):107–116. [cited 2013 Aug 12]; Available from: http://jcem.endojournals.org/content/83/1/107.full.pdf+html. [PubMed: 9435425]
17.: Daugaard JR, et al. Eur J Endocrinol. 1999;141(4):342–349. [PubMed: 10526246]
18.: Degerblad M, et al. Eur J Endocrinol. 1995;133(2):180–188. [PubMed: 7655642]
19.: Florkowski CM, et al. Psychoneuroendocrinology. 1998;23(1):57–63. [PubMed: 9618752]
20.: Holmes SJ, et al. Clin Endocrinol (Oxf). 1995;43(2):151–157. [PubMed: 7554309]
21.: Holmes SJ, et al. Clin Endocrinol (Oxf). 1995;42(6):627–633. [PubMed: 7634504]
22.: Hwu CM, et al. J Clin Endocrinol Metab [Internet] 1997;82(10):3285–3292. [cited 2013 Aug 8]; Available from: http://jcem.endojournals.org/content/82/10/3285.full.pdf+html. [PubMed: 9329355]
23.: RIrie M, et al. Endocrinology and Metabolism, Supplement. 1995;2(B):17–23.
24.: Janssen YJ, et al. J Clin Endocrinol Metab [Internet] 1997 Jan;82(1):129–135. [cited 2013 Aug 12]; Available from: http://jcem.endojournals.org/content/82/1/129.full.pdf+html. [PubMed: 8989246]
25.: Janssen YJH, et al. J Clin Endocrinol Metab [Internet] 1998;83(6):2143–2148. [cited 13 A.D. Aug 12]; Available from: http://jcem.endojournals.org/content/83/6/2143.full.pdf+html. [PubMed: 9626153]
26.: Johannsson G, et al. J Clin Endocrinol Metab. 1996;81(4):1575–1581. [PubMed: 8636370]
27.: Johansson JO, et al. Metab Clin Exp. 1996;45(3):362–369. [PubMed: 8606645]
28.: Kann P, et al. Endocrinology and Metabolism. 1995;2 Suppl B:103–110.
29.: Kann P, et al. Exp Clin Endocrinol Diabetes. 1996;104(4):327–333. [PubMed: 8886750]
30.: Kato Y, et al. Endocr J [Internet] 1996;43(2):177–183. [cited 2013 Aug 12]; Available from: https://www.jstage.jst.go.jp/article/endocrj1993/43/2/43_2_177/_pdf. [PubMed: 8793333]
31.: Mahajan T, et al. Eur J Endocrinol [Internet] 2004 Sep;151(3):325–332. [cited 2013 Aug 12]; Available from: http://eje-online.org/cgi/reprint/151/3/325. [PubMed: 15362961]
32.: Miller KK, et al. J Clin Endocrinol Metab [Internet] 2010;95(2):567–577. [cited 2013 Aug 12]; Available from: http://jcem.endojournals.org/content/95/2/567.full.pdf+html. [PMC free article: PMC2840863] [PubMed: 20061426]
33.: Oomen PHN, et al. Scand J Clin Lab Invest. 2002;62(1):1–6. [PubMed: 12002407]
34.: Oscarsson J, et al. Metab Clin Exp. 1996;45(3):370–377. [PubMed: 8606646]
35.: Riedl M, et al. J Am Soc Nephrol [Internet] 1995;6(5):1434–1438. [cited 2013 Aug 8]; Available from: http://jasn.asnjournals.org/content/6/5/1434.full.pdf. [PubMed: 8589319]
36.: Rodriguez-Arnao J, et al. Clin Endocrinol (Oxf). 1998 Apr;48(4):455–462. [PubMed: 9640412]
37.: RefRoelen CAM, et al. Metab Clin Exp. 1999;48(3):314–318. [PubMed: 10094106]
38.: Rosenfalck AM, et al. Growth Hormone and IGF Research. 1999;9(2):96–105. [PubMed: 10373342]
39.: Sneppen SB, et al. Eur J Endocrinol. 2002;146(2):187–195. [PubMed: 11834427]
40.: Soares CDN, et al. Arq Neuropsiquiatr. 1999;57(2 A):182–189. [PubMed: 10412515]
41.: Tanriverdi F, et al. Clin Endocrinol (Oxf). 2006;65(5):579–585. [PubMed: 17054457]
42.: Thoren M, et al. J Clin Endocrinol Metab [Internet] 1997;82(1):223–228. [cited 2013 Aug 8]; Available from: http://jcem.endojournals.org/content/82/1/223.full.pdf+html. [PubMed: 8989263]
43.: Verhelst J, et al. Clin Endocrinol (Oxf). 1997 Oct;47(4):485–94. [PubMed: 9404448]
44.: Walker BR, et al. Clin Endocrinol (Oxf). 1998;49(2):257–263. [PubMed: 9828916]
45.: Weaver JU, et al. J Clin Endocrinol Metab. 1995;80(1):153–159. [PubMed: 7829604]
46.: Weaver JU, et al. Endocrinology and Metabolism. 1996;3(1):55–61.

Inappropriate Intervention

1.: Biller BM, et al. Pituitary. 2012 Aug 23

Inappropriate Population

1.: Albin AK, et al. Horm Res Paediatr. 2011;76(4):262–272. [PubMed: 21921571]

Study Design

1.: Chihara K, et al. Growth Hormone and IGF Research. 2008;18(4):307–317. [PubMed: 18282776]
2.: Claessen KMJA, et al. J Clin Endocrinol Metab. 2013;98(1):352–361. [PubMed: 23162104]
3.: Holmes SJ, et al. Clin Endocrinol (Oxf). 1995;43(2):143–149. [PubMed: 7554308]
4.: Johansson JO, et al. Thromb Haemost. 1996;76(3):422–428. [PubMed: 8883281]
5.: Mardh G, et al. Endocrinology and Metabolism. 1995;2 Suppl B:11–16.
6.: Monson JP. Eur J Endocrinol. 2003 Apr;148 Suppl 2:S9–S14. [PubMed: 12670295]
7.: van der Klaauw A, et al. Eur J Endocrinol [Internet] 2006;155(5):701–708. [cited 2013 Aug 8]; Available from: http://eje-online.org/content/155/5/701.full.pdf+html.
8.: van der Klaauw AA, et al. Eur J Endocrinol [Internet] 2007;156(4):455–462. [cited 2013 Aug 8]; Available from: http://eje-online.org/content/156/4/455.full.pdf+html. [PubMed: 17389460]

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Somatropin (Genotropin) (0.15 mg/day to 0.3 mg/day): Replacement of Endogenous Growth Hormone in Adults with Growth Hormone Deficiency [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Jan. APPENDIX 3, EXCLUDED STUDIES.