Skip to main content
Top
Published in: Archives of Osteoporosis 1/2018

Open Access 01-12-2018 | Original Article

Real-world effectiveness of osteoporosis therapies for fracture reduction in post-menopausal women

Authors: Akeem A. Yusuf, Steven R. Cummings, Nelson B. Watts, Maurille Tepie Feudjo, J. Michael Sprafka, Jincheng Zhou, Haifeng Guo, Akhila Balasubramanian, Cyrus Cooper

Published in: Archives of Osteoporosis | Issue 1/2018

Login to get access

Abstract

Summary

Studies examining real-world effectiveness of osteoporosis therapies are beset by limitations due to confounding by indication. By evaluating longitudinal changes in fracture incidence, we demonstrated that osteoporosis therapies are effective in reducing fracture risk in real-world practice settings.

Introduction

Osteoporosis therapies have been shown to reduce incidence of vertebral and non-vertebral fractures in placebo-controlled randomized clinical trials. However, information on the real-world effectiveness of these therapies is limited.

Methods

We examined fracture risk reduction in older, post-menopausal women treated with osteoporosis therapies. Using Medicare claims, we identified 1,278,296 women age ≥ 65 years treated with zoledronic acid, oral bisphosphonates, denosumab, teriparatide, or raloxifene. Fracture incidence rates before and after treatment initiation were described to understand patients’ fracture risk profile, and fracture reduction effectiveness of each therapy was evaluated as a longitudinal change in incidence rates.

Results

Fracture incidence rates increased during the period leading up to treatment initiation and were highest in the 3-month period most proximal to treatment initiation. Fracture incidence rates following treatment initiation were significantly lower than before treatment initiation. Compared with the 12-month pre-index period, there were reductions in clinical vertebral fractures for denosumab (45%; 95% confidence interval [CI] 39–51%), zoledronic acid (50%; 95% CI 47–52%), oral bisphosphonates (24%; 95% CI 22–26%), and teriparatide (72%; 95% CI 69–75%) during the subsequent 12 months. Relative to the first 3 months after initiation, clinical vertebral fractures were reduced for denosumab (51%; 95% CI 42–59%), zoledronic acid (25%; 95% CI 17–32%), oral bisphosphonates (23%; 95% CI 20–26%), and teriparatide (64%; 95% CI 58–69%) during the subsequent 12 months.

Conclusion

In summary, reductions in fracture incidence over time were observed in cohorts of patients treated with osteoporosis therapies.
Appendix
Available only for authorised users
Literature
2.
go back to reference Mauck KF, Clarke BL (2006) Diagnosis, screening, prevention, and treatment of osteoporosis. Mayo Clin Proc 81:662–672CrossRef Mauck KF, Clarke BL (2006) Diagnosis, screening, prevention, and treatment of osteoporosis. Mayo Clin Proc 81:662–672CrossRef
3.
go back to reference Rousculp MD, Long SR, Wang S, Schoenfeld MJ, Meadows ES (2007) Economic burden of osteoporosis-related fractures in Medicaid. Value Health 10:144–152CrossRef Rousculp MD, Long SR, Wang S, Schoenfeld MJ, Meadows ES (2007) Economic burden of osteoporosis-related fractures in Medicaid. Value Health 10:144–152CrossRef
4.
go back to reference Liu SK, Munson JC, Bell JE, Zaha RL, Mecchella JN, Tosteson ANA, Morden NE (2013) Quality of osteoporosis care of older Medicare recipients with fragility fractures: 2006 to 2010. J Am Geriatr Soc 61:1855–1862CrossRef Liu SK, Munson JC, Bell JE, Zaha RL, Mecchella JN, Tosteson ANA, Morden NE (2013) Quality of osteoporosis care of older Medicare recipients with fragility fractures: 2006 to 2010. J Am Geriatr Soc 61:1855–1862CrossRef
5.
go back to reference Tajeu GS, Delzell E, Smith W et al (2014) Death, debility, and destitution following hip fracture. J Gerontol A Biol Sci Med Sci 69:346–353CrossRef Tajeu GS, Delzell E, Smith W et al (2014) Death, debility, and destitution following hip fracture. J Gerontol A Biol Sci Med Sci 69:346–353CrossRef
6.
go back to reference Bilezikian JP (2009) Efficacy of bisphosphonates in reducing fracture risk in postmenopausal osteoporosis. Am J Med 122(2 Suppl):S14–S21CrossRef Bilezikian JP (2009) Efficacy of bisphosphonates in reducing fracture risk in postmenopausal osteoporosis. Am J Med 122(2 Suppl):S14–S21CrossRef
7.
go back to reference Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C, FREEDOM Trial (2009) Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 361:756–765CrossRef Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C, FREEDOM Trial (2009) Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 361:756–765CrossRef
8.
go back to reference Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR, HORIZON Pivotal Fracture Trial (2007) Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 356:1809–1822CrossRef Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR, HORIZON Pivotal Fracture Trial (2007) Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 356:1809–1822CrossRef
9.
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, Mellström D, Oefjord ES, Marcinowska-Suchowierska E, Salmi J, Mulder H, Halse J, Sawicki AZ, Mitlak BH (2001) Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 344:1434–1441CrossRef Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, Hodsman AB, Eriksen EF, Ish-Shalom S, Genant HK, Wang O, Mellström D, Oefjord ES, Marcinowska-Suchowierska E, Salmi J, Mulder H, Halse J, Sawicki AZ, Mitlak BH (2001) Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 344:1434–1441CrossRef
10.
go back to reference Cadarette SM, Katz JN, Brookhart MA, Sturmer T, Stedman MR, Solomon DH (2008) Relative effectiveness of osteoporosis drugs for preventing nonvertebral fracture. Ann Intern Med 148:637–646CrossRef Cadarette SM, Katz JN, Brookhart MA, Sturmer T, Stedman MR, Solomon DH (2008) Relative effectiveness of osteoporosis drugs for preventing nonvertebral fracture. Ann Intern Med 148:637–646CrossRef
11.
go back to reference Lin TC, Yang CY, Yang YH, Lin SJ (2013) Comparative effectiveness of osteoporosis drugs in preventing secondary nonvertebral fractures in Taiwanese women. J Clin Endocrinol Metab 98:4717–4726CrossRef Lin TC, Yang CY, Yang YH, Lin SJ (2013) Comparative effectiveness of osteoporosis drugs in preventing secondary nonvertebral fractures in Taiwanese women. J Clin Endocrinol Metab 98:4717–4726CrossRef
12.
go back to reference Yun H, Delzell E, Saag KG, Kilgore ML, Morrisey MA, Muntner P, Matthews R, Guo L, Wright N, Smith W, Colón-Emeric C, O'Connor CM, Lyles KW, Curtis JR (2015) Fractures and mortality in relation to different osteoporosis treatments. Clin Exp Rheumatol 33:302–309PubMed Yun H, Delzell E, Saag KG, Kilgore ML, Morrisey MA, Muntner P, Matthews R, Guo L, Wright N, Smith W, Colón-Emeric C, O'Connor CM, Lyles KW, Curtis JR (2015) Fractures and mortality in relation to different osteoporosis treatments. Clin Exp Rheumatol 33:302–309PubMed
13.
go back to reference Abelson A, Ringe JD, Gold DT, Lange JL, Thomas T (2010) Longitudinal change in clinical fracture incidence after initiation of bisphosphonates. Osteoporos Int 21:1021–1029CrossRef Abelson A, Ringe JD, Gold DT, Lange JL, Thomas T (2010) Longitudinal change in clinical fracture incidence after initiation of bisphosphonates. Osteoporos Int 21:1021–1029CrossRef
14.
go back to reference Ray WA, Griffin MR, Fought RL, Adams ML (1992) Identification of fractures from computerized Medicare files. J Clin Epidemiol 45:703–714CrossRef Ray WA, Griffin MR, Fought RL, Adams ML (1992) Identification of fractures from computerized Medicare files. J Clin Epidemiol 45:703–714CrossRef
15.
go back to reference Curtis JR, Mudano AS, Solomon DH, Xi J, Melton ME, Saag KG (2009) Identification and validation of vertebral compression fractures using administrative claims data. Med Care 47:69–72CrossRef Curtis JR, Mudano AS, Solomon DH, Xi J, Melton ME, Saag KG (2009) Identification and validation of vertebral compression fractures using administrative claims data. Med Care 47:69–72CrossRef
16.
go back to reference Prieto-Alhambra D, Pagès-Castellà A, Wallace G, Javaid MK, Judge A, Nogués X, Arden NK, Cooper C, Diez-Perez A (2014) Predictors of fracture while on treatment with oral bisphosphonates: a population-based cohort study. J Bone Miner Res 29:268–274CrossRef Prieto-Alhambra D, Pagès-Castellà A, Wallace G, Javaid MK, Judge A, Nogués X, Arden NK, Cooper C, Diez-Perez A (2014) Predictors of fracture while on treatment with oral bisphosphonates: a population-based cohort study. J Bone Miner Res 29:268–274CrossRef
17.
go back to reference Taylor AJ, Gary LC, Arora T, Becker DJ, Curtis JR, Kilgore ML, Morrisey MA, Saag KG, Matthews R, Yun H, Smith W, Delzell E (2011) Clinical and demographic factors associated with fractures among older Americans. Osteoporos Int 22:1263–1274CrossRef Taylor AJ, Gary LC, Arora T, Becker DJ, Curtis JR, Kilgore ML, Morrisey MA, Saag KG, Matthews R, Yun H, Smith W, Delzell E (2011) Clinical and demographic factors associated with fractures among older Americans. Osteoporos Int 22:1263–1274CrossRef
18.
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 12:209CrossRef 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 12:209CrossRef
19.
go back to reference Murad MH, Drake MT, Mullan RJ, Mauck KF, Stuart LM, Lane MA, Abu Elnour NO, Erwin PJ, Hazem A, Puhan MA, Li T, Montori VM (2012) Clinical review. Comp Eff Drug Treat Prev Fragility Fractures 97:1871–1880 Murad MH, Drake MT, Mullan RJ, Mauck KF, Stuart LM, Lane MA, Abu Elnour NO, Erwin PJ, Hazem A, Puhan MA, Li T, Montori VM (2012) Clinical review. Comp Eff Drug Treat Prev Fragility Fractures 97:1871–1880
20.
go back to reference Freemantle N, Cooper C, Diez-Perez A, Gitlin M, Radcliffe H, Shepherd S, Roux C (2013) Results of indirect and mixed treatment comparison of fracture efficacy for osteoporosis treatments: a meta-analysis. Osteoporos Int 24:209–217CrossRef Freemantle N, Cooper C, Diez-Perez A, Gitlin M, Radcliffe H, Shepherd S, Roux C (2013) Results of indirect and mixed treatment comparison of fracture efficacy for osteoporosis treatments: a meta-analysis. Osteoporos Int 24:209–217CrossRef
21.
go back to reference Migliore A, Broccoli S, Massafra U, Cassol M, Frediani B (2013) Ranking antireabsorptive agents to prevent vertebral fractures in postmenopausal osteoporosis by mixed treatment comparison meta-analysis. Eur Rev Med Pharmacol Sci 17:658–667PubMed Migliore A, Broccoli S, Massafra U, Cassol M, Frediani B (2013) Ranking antireabsorptive agents to prevent vertebral fractures in postmenopausal osteoporosis by mixed treatment comparison meta-analysis. Eur Rev Med Pharmacol Sci 17:658–667PubMed
22.
go back to reference Crandall CJ, Newberry SJ, Diamant A, Lim YW, Gellad WF, Booth MJ, Motala A, Shekelle PG (2014) Comparative effectiveness of pharmacologic treatments to prevent fractures. Ann Intern Med 161:711–723CrossRef Crandall CJ, Newberry SJ, Diamant A, Lim YW, Gellad WF, Booth MJ, Motala A, Shekelle PG (2014) Comparative effectiveness of pharmacologic treatments to prevent fractures. Ann Intern Med 161:711–723CrossRef
23.
go back to reference Ferrari S, Nakamura T, Hagino H, Fujiwara S, Lange JL, Watts NB (2011) Longitudinal change in hip fracture incidence after starting risedronate or raloxifene: an observational study. J Bone Miner Metab 29:561–570CrossRef Ferrari S, Nakamura T, Hagino H, Fujiwara S, Lange JL, Watts NB (2011) Longitudinal change in hip fracture incidence after starting risedronate or raloxifene: an observational study. J Bone Miner Metab 29:561–570CrossRef
24.
go back to reference Thomas T, Horlait S, Ringe JD, Abelson A, Gold DT, Atlan P, Lange JL (2013) Oral bisphosphonates reduce the risk of clinical fractures in glucocorticoid-induced osteoporosis in clinical practice. Osteoporos Int 24:263–269CrossRef Thomas T, Horlait S, Ringe JD, Abelson A, Gold DT, Atlan P, Lange JL (2013) Oral bisphosphonates reduce the risk of clinical fractures in glucocorticoid-induced osteoporosis in clinical practice. Osteoporos Int 24:263–269CrossRef
25.
go back to reference van Geel TA, Huntjens KM, van den Bergh JP, Dinant GJ, Geusens PP (2010) Timing of subsequent fractures after an initial fracture. Curr Osteoporos Rep 8(3):118–122CrossRef van Geel TA, Huntjens KM, van den Bergh JP, Dinant GJ, Geusens PP (2010) Timing of subsequent fractures after an initial fracture. Curr Osteoporos Rep 8(3):118–122CrossRef
26.
go back to reference Johnell O, Kanis JA, Odén A, Sernbo I, Redlund-Johnell I, Petterson C, De Laet C, Jönsson B (2004) Fracture risk following an osteoporotic fracture. Osteoporos Int 15(3):175–179CrossRef Johnell O, Kanis JA, Odén A, Sernbo I, Redlund-Johnell I, Petterson C, De Laet C, Jönsson B (2004) Fracture risk following an osteoporotic fracture. Osteoporos Int 15(3):175–179CrossRef
27.
go back to reference Hoffman V, Xue F, Gardstein B, Skerry K, Critchlow CW, Enger C (2014) Development and evaluation of an algorithm to identify users of Prolia(®) during the early postmarketing period using health insurance claims data. Pharmacoepidemiol Drug Saf 23:993–998CrossRef Hoffman V, Xue F, Gardstein B, Skerry K, Critchlow CW, Enger C (2014) Development and evaluation of an algorithm to identify users of Prolia(®) during the early postmarketing period using health insurance claims data. Pharmacoepidemiol Drug Saf 23:993–998CrossRef
28.
go back to reference Doherty RB (2004) Assessing the new Medicare prescription drug law. Ann Intern Med 141(5):391–395CrossRef Doherty RB (2004) Assessing the new Medicare prescription drug law. Ann Intern Med 141(5):391–395CrossRef
Metadata
Title
Real-world effectiveness of osteoporosis therapies for fracture reduction in post-menopausal women
Authors
Akeem A. Yusuf
Steven R. Cummings
Nelson B. Watts
Maurille Tepie Feudjo
J. Michael Sprafka
Jincheng Zhou
Haifeng Guo
Akhila Balasubramanian
Cyrus Cooper
Publication date
01-12-2018
Publisher
Springer London
Published in
Archives of Osteoporosis / Issue 1/2018
Print ISSN: 1862-3522
Electronic ISSN: 1862-3514
DOI
https://doi.org/10.1007/s11657-018-0439-3

Other articles of this Issue 1/2018

Archives of Osteoporosis 1/2018 Go to the issue