Skip to main content
Erschienen in: Journal of Bone and Mineral Metabolism 6/2014

01.11.2014 | Original Article

The safety and effectiveness profile of daily teriparatide in a prospective observational study in Japanese patients with osteoporosis at high risk for fracture: interim report

verfasst von: Takanori Yamamoto, Masanori Taketsuna, Xiaoyan Guo, Masayo Sato, Hideaki Sowa

Erschienen in: Journal of Bone and Mineral Metabolism | Ausgabe 6/2014

Einloggen, um Zugang zu erhalten

Abstract

This postmarketing surveillance study assessed the safety and effectiveness of daily teriparatide treatment in patients with osteoporosis in a Japanese clinical setting. In this prospective, multicenter, observational study, patients with osteoporosis at high risk for fracture received subcutaneous injections of teriparatide (20 μg/day) for a maximum of 24 months. For this interim report, data from 1,671 patients were eligible for analysis at the cutoff date. The mean age was 75.3 years; 93 % of patients (1,552/1,671 patients) were women. There were 117 adverse drug reactions (ADRs) reported in 101 of 1,671 patients (6.04 %); the most common reported ADRs were nausea, dizziness, headache, and palpitations. No clinically significant safety issues were identified, although 5 serious ADRs were reported in 4/1,671 (0.24 %) patients. At 12 months, 71.9 % of patients remained on teriparatide treatment. From 1 month, there were rapid increases in the biomarkers of bone formation P1NP and, to a lesser extent, BAP. In contrast, increases in the biomarkers of bone resorption, serum NTX, urinary NTX, and TRACP5b, were smaller. After 12 months of treatment, there was an increase in bone mineral density at the lumbar spine, femoral neck, and total hip, and a decrease in the Visual Analog Scale score for back pain. The incidence of new vertebral and nonvertebral fractures was 1.21 % and 3.18 %, respectively. In conclusion, the favorable safety profile and effectiveness of teriparatide observed in this population of Japanese patients with osteoporosis were accompanied by relatively high persistence with treatment, which is a key factor in the success of osteoporosis treatment.
Literatur
1.
Zurück zum Zitat Yu S, Burge RT, Foster SA, Gelwicks S, Meadows ES (2012) The impact of teriparatide adherence and persistence on fracture outcomes. Osteoporos Int 23:1103–1113PubMedCrossRef Yu S, Burge RT, Foster SA, Gelwicks S, Meadows ES (2012) The impact of teriparatide adherence and persistence on fracture outcomes. Osteoporos Int 23:1103–1113PubMedCrossRef
2.
Zurück zum Zitat Hodsman AB, Bauer DC, Dempster DW, Dian L, Hanley DA, Harris ST, Kendler DL, McClung MR, Miller PD, Olszynski WP, Orwoll E, Yuen CK (2005) Parathyroid hormone and teriparatide for the treatment of osteoporosis: a review of the evidence and suggested guidelines for its use. Endocr Rev 26:688–703PubMedCrossRef Hodsman AB, Bauer DC, Dempster DW, Dian L, Hanley DA, Harris ST, Kendler DL, McClung MR, Miller PD, Olszynski WP, Orwoll E, Yuen CK (2005) Parathyroid hormone and teriparatide for the treatment of osteoporosis: a review of the evidence and suggested guidelines for its use. Endocr Rev 26:688–703PubMedCrossRef
3.
Zurück zum Zitat Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, Hodsman AB, Eriksen EF, Ish-Shalom S, Genant HK, Wang O, Mitlak BH (2001) Effect of parathyroid hormone (1–34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 344:1434–1441PubMedCrossRef Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, Hodsman AB, Eriksen EF, Ish-Shalom S, Genant HK, Wang O, Mitlak BH (2001) Effect of parathyroid hormone (1–34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 344:1434–1441PubMedCrossRef
4.
Zurück zum Zitat McClung MR, San Martin J, Miller PD, Civitelli R, Bandeira F, Omizo M, Donley DW, Dalsky GP, Eriksen EF (2005) Opposite bone remodeling effects of teriparatide and alendronate in increasing bone mass. Arch Intern Med 165:1762–1768PubMedCrossRef McClung MR, San Martin J, Miller PD, Civitelli R, Bandeira F, Omizo M, Donley DW, Dalsky GP, Eriksen EF (2005) Opposite bone remodeling effects of teriparatide and alendronate in increasing bone mass. Arch Intern Med 165:1762–1768PubMedCrossRef
5.
Zurück zum Zitat Boonen S, Marin F, Obermayer-Pietsch B, Simoes ME, Barker C, Glass EV, Hadji P, Lyritis G, Oertel H, Nickelsen T, McCloskey EV, Eurofors Investigators (2008) Effects of previous antiresorptive therapy on the bone mineral density response to two years of teriparatide treatment in postmenopausal women with osteoporosis. J Clin Endocrinol Metab 93:852–860PubMedCrossRef Boonen S, Marin F, Obermayer-Pietsch B, Simoes ME, Barker C, Glass EV, Hadji P, Lyritis G, Oertel H, Nickelsen T, McCloskey EV, Eurofors Investigators (2008) Effects of previous antiresorptive therapy on the bone mineral density response to two years of teriparatide treatment in postmenopausal women with osteoporosis. J Clin Endocrinol Metab 93:852–860PubMedCrossRef
6.
Zurück zum Zitat Orwoll ES, Scheele WH, Paul S, Adami S, Syversen U, Diez-Perez A, Kaufman JM, Clancy AD, Gaich GA (2003) The effect of teriparatide [human parathyroid hormone (1–34)] therapy on bone density in men with osteoporosis. J Bone Miner Res 18:9–17PubMedCrossRef Orwoll ES, Scheele WH, Paul S, Adami S, Syversen U, Diez-Perez A, Kaufman JM, Clancy AD, Gaich GA (2003) The effect of teriparatide [human parathyroid hormone (1–34)] therapy on bone density in men with osteoporosis. J Bone Miner Res 18:9–17PubMedCrossRef
7.
Zurück zum Zitat Saag KG, Zanchetta JR, Devogelaer JP, Adler RA, Eastell R, See K, Krege JH, Krohn K, Warner MR (2009) Effects of teriparatide versus alendronate for treating glucocorticoid-induced osteoporosis: thirty-six-month results of a randomized, double-blind, controlled trial. Arthritis Rheum 60:3346–3355PubMedCrossRef Saag KG, Zanchetta JR, Devogelaer JP, Adler RA, Eastell R, See K, Krege JH, Krohn K, Warner MR (2009) Effects of teriparatide versus alendronate for treating glucocorticoid-induced osteoporosis: thirty-six-month results of a randomized, double-blind, controlled trial. Arthritis Rheum 60:3346–3355PubMedCrossRef
8.
Zurück zum Zitat Langdahl BL, Rajzbaum G, Jakob F, Karras D, Ljunggren O, Lems WF, Fahrleitner-Pammer A, Walsh JB, Barker C, Kutahov A, Marin F (2009) Reduction in fracture rate and back pain and increased quality of life in postmenopausal women treated with teriparatide: 18-month data from the European Forsteo Observational Study (EFOS). Calcif Tissue Int 85:484–493PubMedCentralPubMedCrossRef Langdahl BL, Rajzbaum G, Jakob F, Karras D, Ljunggren O, Lems WF, Fahrleitner-Pammer A, Walsh JB, Barker C, Kutahov A, Marin F (2009) Reduction in fracture rate and back pain and increased quality of life in postmenopausal women treated with teriparatide: 18-month data from the European Forsteo Observational Study (EFOS). Calcif Tissue Int 85:484–493PubMedCentralPubMedCrossRef
9.
Zurück zum Zitat Fahrleitner-Pammer A, Langdahl BL, Marin F, Jakob F, Karras D, Barrett A, Ljunggren O, Walsh JB, Rajzbaum G, Barker C, Lems WF (2011) Fracture rate and back pain during and after discontinuation of teriparatide: 36-month data from the European Forsteo Observational Study (EFOS). Osteoporos Int 22:2709–2719PubMedCentralPubMedCrossRef Fahrleitner-Pammer A, Langdahl BL, Marin F, Jakob F, Karras D, Barrett A, Ljunggren O, Walsh JB, Rajzbaum G, Barker C, Lems WF (2011) Fracture rate and back pain during and after discontinuation of teriparatide: 36-month data from the European Forsteo Observational Study (EFOS). Osteoporos Int 22:2709–2719PubMedCentralPubMedCrossRef
10.
Zurück zum Zitat Miyauchi A, Matsumoto T, Shigeta H, Tsujimoto M, Thiebaud D, Nakamura T (2008) Effect of teriparatide on bone mineral density and biochemical markers in Japanese women with postmenopausal osteoporosis: a 6-month dose–response study. J Bone Miner Metab 26:624–634PubMedCrossRef Miyauchi A, Matsumoto T, Shigeta H, Tsujimoto M, Thiebaud D, Nakamura T (2008) Effect of teriparatide on bone mineral density and biochemical markers in Japanese women with postmenopausal osteoporosis: a 6-month dose–response study. J Bone Miner Metab 26:624–634PubMedCrossRef
11.
Zurück zum Zitat Miyauchi A, Matsumoto T, Sugimoto T, Tsujimoto M, Warner MR, Nakamura T (2010) Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study: 12-month, randomized, placebo-controlled, double-blind and 12-month open-label phases. Bone (NY) 47:493–502CrossRef Miyauchi A, Matsumoto T, Sugimoto T, Tsujimoto M, Warner MR, Nakamura T (2010) Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study: 12-month, randomized, placebo-controlled, double-blind and 12-month open-label phases. Bone (NY) 47:493–502CrossRef
12.
Zurück zum Zitat Nakamura T, Tsujimoto M, Hamaya E, Sowa H, Chen P (2012) Consistency of fracture risk reduction in Japanese and Caucasian osteoporosis patients treated with teriparatide: a meta-analysis. J Bone Miner Metab 30:321–325PubMedCrossRef Nakamura T, Tsujimoto M, Hamaya E, Sowa H, Chen P (2012) Consistency of fracture risk reduction in Japanese and Caucasian osteoporosis patients treated with teriparatide: a meta-analysis. J Bone Miner Metab 30:321–325PubMedCrossRef
13.
Zurück zum Zitat Tsujimoto M, Uenaka K, Iwata A, Higashiuchi Y, Sowa H (2012) Effects of teriparatide in Japanese and non-Japanese populations: bridging findings on pharmacokinetics and efficacy. J Bone Miner Metab 30:326–337PubMedCrossRef Tsujimoto M, Uenaka K, Iwata A, Higashiuchi Y, Sowa H (2012) Effects of teriparatide in Japanese and non-Japanese populations: bridging findings on pharmacokinetics and efficacy. J Bone Miner Metab 30:326–337PubMedCrossRef
14.
Zurück zum Zitat Orimo H, Hayashi Y, Fukunaga M, Sone T, Fujiwara S, Shiraki M, Kushida K, Miyamoto S, Soen S, Nishimura J, Oh-Hashi Y, Hosoi T, Gorai I, Tanaka H, Igai T, Kishimoto H, Osteoporosis Diagnostic Criteria Review Committee: Japanese Society for Bone and Mineral Research (2001) Diagnostic criteria for primary osteoporosis: year 2000 revision. J Bone Miner Metab 19:331–337PubMedCrossRef Orimo H, Hayashi Y, Fukunaga M, Sone T, Fujiwara S, Shiraki M, Kushida K, Miyamoto S, Soen S, Nishimura J, Oh-Hashi Y, Hosoi T, Gorai I, Tanaka H, Igai T, Kishimoto H, Osteoporosis Diagnostic Criteria Review Committee: Japanese Society for Bone and Mineral Research (2001) Diagnostic criteria for primary osteoporosis: year 2000 revision. J Bone Miner Metab 19:331–337PubMedCrossRef
15.
Zurück zum Zitat Forteo [prescribing information] (2011) Kobe, Japan: Eli Lilly Japan K.K. Forteo [prescribing information] (2011) Kobe, Japan: Eli Lilly Japan K.K.
16.
Zurück zum Zitat Tsujimoto M, Chen P, Miyauchi A, Sowa H, Krege JH (2011) PINP as an aid for monitoring patients treated with teriparatide. Bone (NY) 48:798–803CrossRef Tsujimoto M, Chen P, Miyauchi A, Sowa H, Krege JH (2011) PINP as an aid for monitoring patients treated with teriparatide. Bone (NY) 48:798–803CrossRef
17.
Zurück zum Zitat Obermayer-Pietsch BM, Marin F, McCloskey EV, Hadji P, Farrerons J, Boonen S, Audran M, Barker C, Anastasilakis AD, Fraser WD, Nickelsen T, Eurofors Investigators (2008) Effects of two years of daily teriparatide treatment on BMD in postmenopausal women with severe osteoporosis with and without prior antiresorptive treatment. J Bone Miner Res 23:1591–1600PubMedCrossRef Obermayer-Pietsch BM, Marin F, McCloskey EV, Hadji P, Farrerons J, Boonen S, Audran M, Barker C, Anastasilakis AD, Fraser WD, Nickelsen T, Eurofors Investigators (2008) Effects of two years of daily teriparatide treatment on BMD in postmenopausal women with severe osteoporosis with and without prior antiresorptive treatment. J Bone Miner Res 23:1591–1600PubMedCrossRef
18.
Zurück zum Zitat Eastell R, Nickelsen T, Marin F, Barker C, Hadji P, Farrerons J, Audran M, Boonen S, Brixen K, Gomes JM, Obermayer-Pietsch B, Avramidis A, Sigurdsson G, Gluer CC (2009) Sequential treatment of severe postmenopausal osteoporosis after teriparatide: final results of the randomized, controlled European Study of Forsteo (EUROFORS). J Bone Miner Res 24:726–736PubMedCrossRef Eastell R, Nickelsen T, Marin F, Barker C, Hadji P, Farrerons J, Audran M, Boonen S, Brixen K, Gomes JM, Obermayer-Pietsch B, Avramidis A, Sigurdsson G, Gluer CC (2009) Sequential treatment of severe postmenopausal osteoporosis after teriparatide: final results of the randomized, controlled European Study of Forsteo (EUROFORS). J Bone Miner Res 24:726–736PubMedCrossRef
19.
Zurück zum Zitat Arden NK, Earl S, Fisher DJ, Cooper C, Carruthers S, Goater M (2006) Persistence with teriparatide in patients with osteoporosis: the UK experience. Osteoporos Int 17:1626–1629PubMedCrossRef Arden NK, Earl S, Fisher DJ, Cooper C, Carruthers S, Goater M (2006) Persistence with teriparatide in patients with osteoporosis: the UK experience. Osteoporos Int 17:1626–1629PubMedCrossRef
20.
Zurück zum Zitat Briot K, Ravaud P, Dargent-Molina P, Zylberman M, Liu-Leage S, Roux C (2009) Persistence with teriparatide in postmenopausal osteoporosis; impact of a patient education and follow-up program: the French experience. Osteoporos Int 20:625–630PubMedCrossRef Briot K, Ravaud P, Dargent-Molina P, Zylberman M, Liu-Leage S, Roux C (2009) Persistence with teriparatide in postmenopausal osteoporosis; impact of a patient education and follow-up program: the French experience. Osteoporos Int 20:625–630PubMedCrossRef
21.
Zurück zum Zitat Satterwhite J, Heathman M, Miller PD, Marin F, Glass EV, Dobnig H (2010) Pharmacokinetics of teriparatide (rhPTH[1-34]) and calcium pharmacodynamics in postmenopausal women with osteoporosis. Calcif Tissue Int 87:485–492PubMedCentralPubMedCrossRef Satterwhite J, Heathman M, Miller PD, Marin F, Glass EV, Dobnig H (2010) Pharmacokinetics of teriparatide (rhPTH[1-34]) and calcium pharmacodynamics in postmenopausal women with osteoporosis. Calcif Tissue Int 87:485–492PubMedCentralPubMedCrossRef
22.
Zurück zum Zitat Miller PD (2008) Safety of parathyroid hormone for the treatment of osteoporosis. Curr Osteoporos Rep 6:12–16PubMedCrossRef Miller PD (2008) Safety of parathyroid hormone for the treatment of osteoporosis. Curr Osteoporos Rep 6:12–16PubMedCrossRef
23.
Zurück zum Zitat Seeman E, Compston J, Adachi J, Brandi ML, Cooper C, Dawson-Hughes B, Jonsson B, Pols H, Cramer JA (2007) Non-compliance: the Achilles’ heel of anti-fracture efficacy. Osteoporos Int 18:711–719PubMedCrossRef Seeman E, Compston J, Adachi J, Brandi ML, Cooper C, Dawson-Hughes B, Jonsson B, Pols H, Cramer JA (2007) Non-compliance: the Achilles’ heel of anti-fracture efficacy. Osteoporos Int 18:711–719PubMedCrossRef
24.
Zurück zum Zitat Siris ES, Selby PL, Saag KG, Borgstrom F, Herings RM, Silverman SL (2009) Impact of osteoporosis treatment adherence on fracture rates in North America and Europe. Am J Med 122:S3–S13PubMedCrossRef Siris ES, Selby PL, Saag KG, Borgstrom F, Herings RM, Silverman SL (2009) Impact of osteoporosis treatment adherence on fracture rates in North America and Europe. Am J Med 122:S3–S13PubMedCrossRef
25.
Zurück zum Zitat Lindsay R, Miller P, Pohl G, Glass EV, Chen P, Krege JH (2009) Relationship between duration of teriparatide therapy and clinical outcomes in postmenopausal women with osteoporosis. Osteoporos Int 20:943–948PubMedCrossRef Lindsay R, Miller P, Pohl G, Glass EV, Chen P, Krege JH (2009) Relationship between duration of teriparatide therapy and clinical outcomes in postmenopausal women with osteoporosis. Osteoporos Int 20:943–948PubMedCrossRef
26.
Zurück zum Zitat Canalis E, Giustina A, Bilezikian JP (2007) Mechanisms of anabolic therapies for osteoporosis. N Engl J Med 357:905–916PubMedCrossRef Canalis E, Giustina A, Bilezikian JP (2007) Mechanisms of anabolic therapies for osteoporosis. N Engl J Med 357:905–916PubMedCrossRef
27.
Zurück zum Zitat Blumsohn A, Marin F, Nickelsen T, Brixen K, Sigurdsson G, Gonzalez de la Vera J, Boonen S, Liu-Leage S, Barker C, Eastell R, Eurofors Study Group (2011) Early changes in biochemical markers of bone turnover and their relationship with bone mineral density changes after 24 months of treatment with teriparatide. Osteoporos Int 22:1935–1946PubMedCentralPubMedCrossRef Blumsohn A, Marin F, Nickelsen T, Brixen K, Sigurdsson G, Gonzalez de la Vera J, Boonen S, Liu-Leage S, Barker C, Eastell R, Eurofors Study Group (2011) Early changes in biochemical markers of bone turnover and their relationship with bone mineral density changes after 24 months of treatment with teriparatide. Osteoporos Int 22:1935–1946PubMedCentralPubMedCrossRef
28.
Zurück zum Zitat Jakob F, Oertel H, Langdahl B, Ljunggren O, Barrett A, Karras D, Walsh JB, Fahrleitner-Pammer A, Rajzbaum G, Barker C, Lems WF, Marin F (2012) Effects of teriparatide in postmenopausal women with osteoporosis pre-treated with bisphosphonates: 36-month results from the European Forsteo Observational Study. Eur J Endocrinol 166:87–97PubMedCentralPubMedCrossRef Jakob F, Oertel H, Langdahl B, Ljunggren O, Barrett A, Karras D, Walsh JB, Fahrleitner-Pammer A, Rajzbaum G, Barker C, Lems WF, Marin F (2012) Effects of teriparatide in postmenopausal women with osteoporosis pre-treated with bisphosphonates: 36-month results from the European Forsteo Observational Study. Eur J Endocrinol 166:87–97PubMedCentralPubMedCrossRef
29.
Zurück zum Zitat Gold DT (1996) The clinical impact of vertebral fractures: quality of life in women with osteoporosis. Bone (NY) 18:185S–189SCrossRef Gold DT (1996) The clinical impact of vertebral fractures: quality of life in women with osteoporosis. Bone (NY) 18:185S–189SCrossRef
30.
Zurück zum Zitat Dowd R, Recker RR, Heaney RP (2000) Study subjects and ordinary patients. Osteoporos Int 11:533–536PubMedCrossRef Dowd R, Recker RR, Heaney RP (2000) Study subjects and ordinary patients. Osteoporos Int 11:533–536PubMedCrossRef
31.
Zurück zum Zitat David C, Confavreux CB, Mehsen N, Paccou J, Leboime A, Legrand E (2010) Severity of osteoporosis: what is the impact of co-morbidities? Joint Bone Spine 77(suppl 2):S103–S106PubMedCrossRef David C, Confavreux CB, Mehsen N, Paccou J, Leboime A, Legrand E (2010) Severity of osteoporosis: what is the impact of co-morbidities? Joint Bone Spine 77(suppl 2):S103–S106PubMedCrossRef
32.
Zurück zum Zitat Dennison EM, Compston JE, Flahive J, Siris ES, Gehlbach SH et al (2012) Effect of co-morbidities on fracture risk: findings from the Global Longitudinal Study of Osteoporosis in Women (GLOW). Bone (NY) 50:1288–1293CrossRef Dennison EM, Compston JE, Flahive J, Siris ES, Gehlbach SH et al (2012) Effect of co-morbidities on fracture risk: findings from the Global Longitudinal Study of Osteoporosis in Women (GLOW). Bone (NY) 50:1288–1293CrossRef
Metadaten
Titel
The safety and effectiveness profile of daily teriparatide in a prospective observational study in Japanese patients with osteoporosis at high risk for fracture: interim report
verfasst von
Takanori Yamamoto
Masanori Taketsuna
Xiaoyan Guo
Masayo Sato
Hideaki Sowa
Publikationsdatum
01.11.2014
Verlag
Springer Japan
Erschienen in
Journal of Bone and Mineral Metabolism / Ausgabe 6/2014
Print ISSN: 0914-8779
Elektronische ISSN: 1435-5604
DOI
https://doi.org/10.1007/s00774-013-0546-6

Weitere Artikel der Ausgabe 6/2014

Journal of Bone and Mineral Metabolism 6/2014 Zur Ausgabe

Leitlinien kompakt für die Innere Medizin

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Update Innere Medizin

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.