Skip to main content
Top
Published in: Calcified Tissue International 2/2019

01-02-2019 | Original Research

Reduction of Hip and Other Fractures in Patients Receiving Teriparatide in Real-World Clinical Practice: Integrated Analysis of Four Prospective Observational Studies

Authors: Stuart Silverman, Bente L. Langdahl, Saeko Fujiwara, Ken Saag, Nicola Napoli, Satoshi Soen, Hiroyuki Enomoto, Thomas E. Melby, Damon P. Disch, Fernando Marin, John H. Krege

Published in: Calcified Tissue International | Issue 2/2019

Login to get access

Abstract

The phase 3 teriparatide Fracture Prevention Trial showed significant reductions in vertebral (VF) and nonvertebral (NVF) fractures; however, patient exposure was insufficient for full analysis of low-incidence fractures, including hip. We assessed fracture results in pooled data from four prospective, observational teriparatide studies. Ambulatory women and men with osteoporosis received subcutaneous teriparatide 20 µg/day for up to 24 months per routine clinical practice. Fracture rates were compared between 6-month periods, using 0 to 6 months of treatment as the reference period. Analyses used a piecewise exponential model for first fracture. Hip, NVF, clinical VF (CVF), any clinical, and wrist fractures were assessed. For 8828 patients analyzed, mean age was 71 years; mean (SD) treatment duration was 17.4 (8.6) months. The rate of hip fracture decreased significantly for the > 12 to 18-month (− 47.7%) and > 18-month periods (-85.2%) versus the first 6 months of therapy, and for the > 18 versus the > 6 to 12-month period. NVF, CVF, and all clinical fractures were all significantly decreased in each post-reference period, with maximum decreases (> 18-month period) of 52.7%, 69.4%, and 61.2%, respectively, versus 0 to 6 months. No significant reduction was seen for rates of wrist fracture. Teriparatide treatment was associated with statistically significant decreases in hip fracture rate, particularly for > 18 months of treatment, and in NVF, CVF, and all clinical fracture rate in real-world patients. These results should be interpreted in the context of the non-controlled design of the source studies.
Appendix
Available only for authorised users
Literature
1.
go back to reference Curtis EM, Moon RJ, Harvey NC, Cooper C (2017) The impact of fragility fracture and approaches to osteoporosis risk assessment worldwide. Bone 104:29–38CrossRefPubMedPubMedCentral Curtis EM, Moon RJ, Harvey NC, Cooper C (2017) The impact of fragility fracture and approaches to osteoporosis risk assessment worldwide. Bone 104:29–38CrossRefPubMedPubMedCentral
2.
go back to reference Boonen S, Autier P, Barette M, Vanderschueren D, Lips P, Haentjens P (2004) Functional outcome and quality of life following hip fracture in elderly women: a prospective controlled study. Osteoporos Int 15:87–94CrossRefPubMed Boonen S, Autier P, Barette M, Vanderschueren D, Lips P, Haentjens P (2004) Functional outcome and quality of life following hip fracture in elderly women: a prospective controlled study. Osteoporos Int 15:87–94CrossRefPubMed
3.
go back to reference Magaziner J, Simonsick EM, Kashner TM, Hebel JR, Kenzora JE (1990) Predictors of functional recovery one year following hospital discharge for hip fracture: a prospective study. J Gerontol 45:M101–M107CrossRefPubMed Magaziner J, Simonsick EM, Kashner TM, Hebel JR, Kenzora JE (1990) Predictors of functional recovery one year following hospital discharge for hip fracture: a prospective study. J Gerontol 45:M101–M107CrossRefPubMed
4.
go back to reference Magaziner J, Lydick E, Hawkes W, Fox KM, Zimmerman SI, Epstein RS, Hebel JR (1997) Excess mortality attributable to hip fracture in white women aged 70 years and older. Am J Public Health 87:1630–1636CrossRefPubMedPubMedCentral Magaziner J, Lydick E, Hawkes W, Fox KM, Zimmerman SI, Epstein RS, Hebel JR (1997) Excess mortality attributable to hip fracture in white women aged 70 years and older. Am J Public Health 87:1630–1636CrossRefPubMedPubMedCentral
5.
go back to reference van Staa TP, Leufkens HG, Cooper C (2002) Does a fracture at one site predict later fractures at other sites? A British cohort study. Osteoporos Int 13:624–629CrossRefPubMed van Staa TP, Leufkens HG, Cooper C (2002) Does a fracture at one site predict later fractures at other sites? A British cohort study. Osteoporos Int 13:624–629CrossRefPubMed
6.
go back to reference Kanis JA, Oden A, McCloskey EV, Johansson H, Wahl DA, Cooper C (2012) A systematic review of hip fracture incidence and probability of fracture worldwide. Osteoporos Int 23:2239–2256CrossRefPubMedPubMedCentral Kanis JA, Oden A, McCloskey EV, Johansson H, Wahl DA, Cooper C (2012) A systematic review of hip fracture incidence and probability of fracture worldwide. Osteoporos Int 23:2239–2256CrossRefPubMedPubMedCentral
7.
go back to reference 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 344:1434–1441CrossRefPubMed 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 344:1434–1441CrossRefPubMed
8.
go back to reference Eriksen EF, Keaveny TM, Gallagher ER, Krege JH (2014) Literature review: The effects of teriparatide therapy at the hip in patients with osteoporosis. Bone 67:246–256CrossRefPubMed Eriksen EF, Keaveny TM, Gallagher ER, Krege JH (2014) Literature review: The effects of teriparatide therapy at the hip in patients with osteoporosis. Bone 67:246–256CrossRefPubMed
9.
go back to reference Burge RT, Disch DP, Gelwicks S, Zhang X, Krege JH (2017) Hip and other fragility fracture incidence in real-world teriparatide-treated patients in the United States. Osteoporos Int 28:799–809CrossRefPubMed Burge RT, Disch DP, Gelwicks S, Zhang X, Krege JH (2017) Hip and other fragility fracture incidence in real-world teriparatide-treated patients in the United States. Osteoporos Int 28:799–809CrossRefPubMed
10.
go back to reference Silverman S, Miller P, Sebba A, Weitz M, Wan X, Alam J, Masica D, Taylor KA, Ruff VA, Krohn K (2013) The direct assessment of nonvertebral fractures in community experience (DANCE) study: 2-year nonvertebral fragility fracture results. Osteoporos Int 24:2309–2317CrossRefPubMedPubMedCentral Silverman S, Miller P, Sebba A, Weitz M, Wan X, Alam J, Masica D, Taylor KA, Ruff VA, Krohn K (2013) The direct assessment of nonvertebral fractures in community experience (DANCE) study: 2-year nonvertebral fragility fracture results. Osteoporos Int 24:2309–2317CrossRefPubMedPubMedCentral
11.
go back to reference 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 85:484–493CrossRefPubMedPubMedCentral 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 85:484–493CrossRefPubMedPubMedCentral
12.
go back to reference Langdahl BL, Ljunggren O, Benhamou CL, Marin F, Kapetanos G, Kocjan T, Lespessailles E, Napoli N, Nikolic T, Petto H, Moll T, Lindh E (2016) Fracture rate, quality of life and back pain in patients with osteoporosis treated with teriparatide: 24-Month Results from the Extended Forsteo Observational Study (ExFOS). Calcif Tissue Int 99:259–271CrossRefPubMedPubMedCentral Langdahl BL, Ljunggren O, Benhamou CL, Marin F, Kapetanos G, Kocjan T, Lespessailles E, Napoli N, Nikolic T, Petto H, Moll T, Lindh E (2016) Fracture rate, quality of life and back pain in patients with osteoporosis treated with teriparatide: 24-Month Results from the Extended Forsteo Observational Study (ExFOS). Calcif Tissue Int 99:259–271CrossRefPubMedPubMedCentral
13.
go back to reference Soen S, Fujiwara S, Takayanagi R, Kajimoto K, Tsujimoto M, Kimura S, Sato M, Krege JH, Enomoto H (2017) Real-world effectiveness of daily teriparatide in Japanese patients with osteoporosis at high risk for fracture: final results from the 24-month Japan Fracture Observational Study (JFOS). Curr Med Res Opin 33:2049–2056CrossRefPubMed Soen S, Fujiwara S, Takayanagi R, Kajimoto K, Tsujimoto M, Kimura S, Sato M, Krege JH, Enomoto H (2017) Real-world effectiveness of daily teriparatide in Japanese patients with osteoporosis at high risk for fracture: final results from the 24-month Japan Fracture Observational Study (JFOS). Curr Med Res Opin 33:2049–2056CrossRefPubMed
14.
go back to reference Miller PD, Silverman SL, Gold DT, Taylor KA, Chen P, Wagman RB (2006) Rationale, objectives and design of the direct analysis of nonvertebral fracture in the community experience (DANCE) study. Osteoporos Int 17:85–90CrossRefPubMed Miller PD, Silverman SL, Gold DT, Taylor KA, Chen P, Wagman RB (2006) Rationale, objectives and design of the direct analysis of nonvertebral fracture in the community experience (DANCE) study. Osteoporos Int 17:85–90CrossRefPubMed
15.
go back to reference Rajzbaum G, Jakob F, Karras D, Ljunggren O, Lems WF, Langdahl BL, Fahrleitner-Pammer A, Walsh JB, Gibson A, Tynan AJ, Marin F (2008) Characterization of patients in the European Forsteo Observational Study (EFOS): postmenopausal women entering teriparatide treatment in a community setting. Curr Med Res Opin 24:377–384CrossRefPubMed Rajzbaum G, Jakob F, Karras D, Ljunggren O, Lems WF, Langdahl BL, Fahrleitner-Pammer A, Walsh JB, Gibson A, Tynan AJ, Marin F (2008) Characterization of patients in the European Forsteo Observational Study (EFOS): postmenopausal women entering teriparatide treatment in a community setting. Curr Med Res Opin 24:377–384CrossRefPubMed
16.
go back to reference Ljunggren O, Benhamou CL, Dekker J, Kapetanos G, Kocjan T, Langdahl BL, Napoli N, Petto H, Nikolic T, Lindh E (2014) Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS). Curr Med Res Opin 30:1607–1616CrossRefPubMed Ljunggren O, Benhamou CL, Dekker J, Kapetanos G, Kocjan T, Langdahl BL, Napoli N, Petto H, Nikolic T, Lindh E (2014) Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS). Curr Med Res Opin 30:1607–1616CrossRefPubMed
17.
go back to reference Soen S, Fujiwara S, Takayanagi R, Sato M, Tsujimoto M, Yamamoto T, Enomoto H, Krege JH (2015) Japan Fracture Observational Study (JFOS): patient characteristics and interim data on the use of daily teriparatide in Japanese patients with osteoporosis. Curr Med Res Opin 31:1771–1779CrossRefPubMed Soen S, Fujiwara S, Takayanagi R, Sato M, Tsujimoto M, Yamamoto T, Enomoto H, Krege JH (2015) Japan Fracture Observational Study (JFOS): patient characteristics and interim data on the use of daily teriparatide in Japanese patients with osteoporosis. Curr Med Res Opin 31:1771–1779CrossRefPubMed
18.
go back to reference 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 20:943–948CrossRefPubMed 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 20:943–948CrossRefPubMed
19.
go back to reference Schwartz AV, Pavo I, Alam J, Disch DP, Schuster D, Harris JM, Krege JH (2016) Teriparatide in patients with osteoporosis and type 2 diabetes. Bone 91:152–158CrossRefPubMed Schwartz AV, Pavo I, Alam J, Disch DP, Schuster D, Harris JM, Krege JH (2016) Teriparatide in patients with osteoporosis and type 2 diabetes. Bone 91:152–158CrossRefPubMed
20.
go back to reference Prevrhal S, Krege JH, Chen P, Genant H, Black DM (2009) Teriparatide vertebral fracture risk reduction determined by quantitative and qualitative radiographic assessment. Curr Med Res Opin 25:921–928CrossRefPubMed Prevrhal S, Krege JH, Chen P, Genant H, Black DM (2009) Teriparatide vertebral fracture risk reduction determined by quantitative and qualitative radiographic assessment. Curr Med Res Opin 25:921–928CrossRefPubMed
21.
go back to reference Kendler DL, Marin F, Zerbini CA, Russo LA, Greenspan SL, Zikan V, Bagur A, Malouf-Sierra J, Lakatos P, Fahrleitner-Pammer A, Lespessailles E, Minisola S, Body JJ, Geusens P, Moricke R, Lopez-Romero P (2017) Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet 391:230–240CrossRefPubMed Kendler DL, Marin F, Zerbini CA, Russo LA, Greenspan SL, Zikan V, Bagur A, Malouf-Sierra J, Lakatos P, Fahrleitner-Pammer A, Lespessailles E, Minisola S, Body JJ, Geusens P, Moricke R, Lopez-Romero P (2017) Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet 391:230–240CrossRefPubMed
22.
go back to reference Haentjens P, Magaziner J, Colon-Emeric CS, Vanderschueren D, Milisen K, Velkeniers B, Boonen S (2010) Meta-analysis: excess mortality after hip fracture among older women and men. Ann Intern Med 152:380–390CrossRefPubMedPubMedCentral Haentjens P, Magaziner J, Colon-Emeric CS, Vanderschueren D, Milisen K, Velkeniers B, Boonen S (2010) Meta-analysis: excess mortality after hip fracture among older women and men. Ann Intern Med 152:380–390CrossRefPubMedPubMedCentral
23.
go back to reference Magaziner J, Hawkes W, Hebel JR, Zimmerman SI, Fox KM, Dolan M, Felsenthal G, Kenzora J (2000) Recovery from hip fracture in eight areas of function. J Gerontol A 55:M498–M507CrossRef Magaziner J, Hawkes W, Hebel JR, Zimmerman SI, Fox KM, Dolan M, Felsenthal G, Kenzora J (2000) Recovery from hip fracture in eight areas of function. J Gerontol A 55:M498–M507CrossRef
24.
go back to reference Dyer SM, Crotty M, Fairhall N, Magaziner J, Beaupre LA, Cameron ID, Sherrington C (2016) A critical review of the long-term disability outcomes following hip fracture. BMC Geriatr 16:158CrossRefPubMedPubMedCentral Dyer SM, Crotty M, Fairhall N, Magaziner J, Beaupre LA, Cameron ID, Sherrington C (2016) A critical review of the long-term disability outcomes following hip fracture. BMC Geriatr 16:158CrossRefPubMedPubMedCentral
25.
go back to reference Johnell O, Kanis JA (2004) An estimate of the worldwide prevalence, mortality and disability associated with hip fracture. Osteoporos Int 15:897–902CrossRefPubMed Johnell O, Kanis JA (2004) An estimate of the worldwide prevalence, mortality and disability associated with hip fracture. Osteoporos Int 15:897–902CrossRefPubMed
26.
go back to reference Hopkins RB, Goeree R, Pullenayegum E, Adachi JD, Papaioannou A, Xie F, Thabane L (2011) The relative efficacy of nine osteoporosis medications for reducing the rate of fractures in post-menopausal women. BMC Musculoskelet Disord 12:209CrossRefPubMedPubMedCentral Hopkins RB, Goeree R, Pullenayegum E, Adachi JD, Papaioannou A, Xie F, Thabane L (2011) The relative efficacy of nine osteoporosis medications for reducing the rate of fractures in post-menopausal women. BMC Musculoskelet Disord 12:209CrossRefPubMedPubMedCentral
27.
go back to reference Miller PD, Hattersley G, Riis BJ, Williams GC, Lau E, Russo LA, Alexandersen P, Zerbini CA, Hu MY, Harris AG, Fitzpatrick LA, Cosman F, Christiansen C (2016) Effect of Abaloparatide vs Placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA 316:722–733CrossRefPubMed Miller PD, Hattersley G, Riis BJ, Williams GC, Lau E, Russo LA, Alexandersen P, Zerbini CA, Hu MY, Harris AG, Fitzpatrick LA, Cosman F, Christiansen C (2016) Effect of Abaloparatide vs Placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA 316:722–733CrossRefPubMed
Metadata
Title
Reduction of Hip and Other Fractures in Patients Receiving Teriparatide in Real-World Clinical Practice: Integrated Analysis of Four Prospective Observational Studies
Authors
Stuart Silverman
Bente L. Langdahl
Saeko Fujiwara
Ken Saag
Nicola Napoli
Satoshi Soen
Hiroyuki Enomoto
Thomas E. Melby
Damon P. Disch
Fernando Marin
John H. Krege
Publication date
01-02-2019
Publisher
Springer US
Published in
Calcified Tissue International / Issue 2/2019
Print ISSN: 0171-967X
Electronic ISSN: 1432-0827
DOI
https://doi.org/10.1007/s00223-018-0485-2

Other articles of this Issue 2/2019

Calcified Tissue International 2/2019 Go to the issue