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Published in: Osteoporosis International 3/2016

Open Access 01-03-2016 | Original Article

Gastrointestinal symptoms and association with medication use patterns, adherence, treatment satisfaction, quality of life, and resource use in osteoporosis: baseline results of the MUSIC-OS study

Authors: A. Modi, S. Sen, J. D. Adachi, S. Adami, B. Cortet, A. L. Cooper, P. Geusens, D. Mellström, J. Weaver, J. P. van den Bergh, A. M. Nguyen, S. Sajjan, MUSIC-OS Study Group

Published in: Osteoporosis International | Issue 3/2016

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Abstract

Summary

The Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study (MUSIC-OS) is a prospective, observational study of women with osteoporosis in Europe and Canada. At baseline, patients with gastrointestinal symptoms reported lower adherence to osteoporosis treatment, treatment satisfaction, and health-related quality of life, than those without gastrointestinal symptoms.

Introduction

The aim of the study was to examine gastrointestinal (GI) symptoms and the association between GI symptoms and treatment adherence, treatment satisfaction, and health-related quality of life (HRQoL) among osteoporotic women in Europe and Canada.

Methods

Baseline results are reported here for a prospective study which enrolled postmenopausal, osteoporotic women who were initiating (new users) or continuing (experienced users) osteoporosis treatment at study entry (baseline). A patient survey was administered at baseline and included the occurrence of GI symptoms during 6-month pre-enrolment, treatment adherence (adherence evaluation of osteoporosis (ADEOS), score 0–22), treatment satisfaction (Osteoporosis Treatment Satisfaction Questionnaire for Medications (OPSAT-Q), score 0–100) and HRQoL (EuroQol-5 dimension (EQ-5D) utility, score 0–1; OPAQ-SV, score 0–100). The association between GI symptoms and ADEOS (experienced users), OPSAT-Q (experienced users), and HRQoL (new and experienced users) was assessed by general linear models adjusted for patient characteristics.

Results

A total of 2959 patients (2275 experienced and 684 new users) were included. Overall, 68.1 % of patients experienced GI symptoms in the past 6 months. Compared with patients without GI symptoms, patients with GI symptoms had lower mean baseline scores on most measures. The mean adjusted differences were ADEOS, −0.43; OPSAT-Q, −5.68; EQ-5D, −0.04 (new users) and −0.06 (experienced users), all P < 0.01. GI symptoms were also associated with lower OPAQ-SV domain scores: physical function, −4.17 (experienced users); emotional status, −4.28 (new users) and −5.68 (experienced users); back pain, −5.82 (new users) and −11.33 (experienced users), all P < 0.01.

Conclusions

Patients with GI symptoms have lower treatment adherence and treatment satisfaction and worse HRQoL than patients without GI symptoms.
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Literature
1.
go back to reference Hernlund E, Svedbom A, Ivergard M, Compston J, Cooper C, Stenmark J, McCloskey EV, Jonsson B, Kanis JA (2013) Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos 8:136CrossRefPubMedPubMedCentral Hernlund E, Svedbom A, Ivergard M, Compston J, Cooper C, Stenmark J, McCloskey EV, Jonsson B, Kanis JA (2013) Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos 8:136CrossRefPubMedPubMedCentral
2.
go back to reference Tarride JE, Hopkins RB, Leslie WD, Morin S, Adachi JD, Papaioannou A, Bessette L, Brown JP, Goeree R (2012) The burden of illness of osteoporosis in Canada. Osteoporos Int 23:2591–2600CrossRefPubMedPubMedCentral Tarride JE, Hopkins RB, Leslie WD, Morin S, Adachi JD, Papaioannou A, Bessette L, Brown JP, Goeree R (2012) The burden of illness of osteoporosis in Canada. Osteoporos Int 23:2591–2600CrossRefPubMedPubMedCentral
3.
go back to reference Guillemin F, Martinez L, Calvert M et al (2013) Fear of falling, fracture history, and comorbidities are associated with health-related quality of life among European and US women with osteoporosis in a large international study. Osteoporos Int 24:3001–3010CrossRefPubMed Guillemin F, Martinez L, Calvert M et al (2013) Fear of falling, fracture history, and comorbidities are associated with health-related quality of life among European and US women with osteoporosis in a large international study. Osteoporos Int 24:3001–3010CrossRefPubMed
4.
go back to reference Sanfelix-Genoves J, Hurtado I, Sanfelix-Gimeno G, Reig-Molla B, Peiro S (2011) Impact of osteoporosis and vertebral fractures on quality-of-life. a population-based study in Valencia, Spain (The FRAVO Study). Health Qual Life Outcomes 9:20CrossRefPubMedPubMedCentral Sanfelix-Genoves J, Hurtado I, Sanfelix-Gimeno G, Reig-Molla B, Peiro S (2011) Impact of osteoporosis and vertebral fractures on quality-of-life. a population-based study in Valencia, Spain (The FRAVO Study). Health Qual Life Outcomes 9:20CrossRefPubMedPubMedCentral
5.
go back to reference Abimanyi-Ochom J, Watts JJ, Borgstrom F et al (2015) Changes in quality of life associated with fragility fractures: Australian arm of the International Cost and Utility Related to Osteoporotic Fractures Study (AusICUROS). Osteoporos Int 26:1781–1790CrossRefPubMedPubMedCentral Abimanyi-Ochom J, Watts JJ, Borgstrom F et al (2015) Changes in quality of life associated with fragility fractures: Australian arm of the International Cost and Utility Related to Osteoporotic Fractures Study (AusICUROS). Osteoporos Int 26:1781–1790CrossRefPubMedPubMedCentral
6.
go back to reference Bliuc D, Nguyen ND, Milch VE, Nguyen TV, Eisman JA, JR Center (2009) Mortality risk associated with low-trauma osteoporotic fracture and subsequent fracture in men and women. JAMA 301:513–521CrossRefPubMed Bliuc D, Nguyen ND, Milch VE, Nguyen TV, Eisman JA, JR Center (2009) Mortality risk associated with low-trauma osteoporotic fracture and subsequent fracture in men and women. JAMA 301:513–521CrossRefPubMed
7.
go back to reference Brozek W, Reichardt B, Kimberger O, Zwerina J, Dimai HP, Kritsch D, Klaushofer K, Zwettler E (2014) Mortality after hip fracture in Austria 2008–2011. Calcif Tissue Int Brozek W, Reichardt B, Kimberger O, Zwerina J, Dimai HP, Kritsch D, Klaushofer K, Zwettler E (2014) Mortality after hip fracture in Austria 2008–2011. Calcif Tissue Int
8.
go back to reference Briesacher BA, Andrade SE, Yood RA, Kahler KH (2007) Consequences of poor compliance with bisphosphonates. Bone 41:882–887CrossRefPubMed Briesacher BA, Andrade SE, Yood RA, Kahler KH (2007) Consequences of poor compliance with bisphosphonates. Bone 41:882–887CrossRefPubMed
9.
go back to reference Wade SW, Curtis JR, Yu J, White J, Stolshek BS, Merinar C, Balasubramanian A, Kallich JD, Adams JL, Viswanathan HN (2012) Medication adherence and fracture risk among patients on bisphosphonate therapy in a large United States health plan. Bone 50:870–875CrossRefPubMed Wade SW, Curtis JR, Yu J, White J, Stolshek BS, Merinar C, Balasubramanian A, Kallich JD, Adams JL, Viswanathan HN (2012) Medication adherence and fracture risk among patients on bisphosphonate therapy in a large United States health plan. Bone 50:870–875CrossRefPubMed
10.
go back to reference Rabenda V, Mertens R, Fabri V, Vanoverloop J, Sumkay F, Vannecke C, Deswaef A, Verpooten GA, Reginster JY (2008) Adherence to bisphosphonates therapy and hip fracture risk in osteoporotic women. Osteoporos Int 19:811–818CrossRefPubMed Rabenda V, Mertens R, Fabri V, Vanoverloop J, Sumkay F, Vannecke C, Deswaef A, Verpooten GA, Reginster JY (2008) Adherence to bisphosphonates therapy and hip fracture risk in osteoporotic women. Osteoporos Int 19:811–818CrossRefPubMed
11.
go back to reference Gallagher AM, Rietbrock S, Olson M, van Staa TP (2008) Fracture outcomes related to persistence and compliance with oral bisphosphonates. J Bone Miner Res 23:1569–1575CrossRefPubMed Gallagher AM, Rietbrock S, Olson M, van Staa TP (2008) Fracture outcomes related to persistence and compliance with oral bisphosphonates. J Bone Miner Res 23:1569–1575CrossRefPubMed
12.
go back to reference Lo JC, Pressman AR, Omar MA, Ettinger B (2006) Persistence with weekly alendronate therapy among postmenopausal women. Osteoporos Int 17:922–928CrossRefPubMed Lo JC, Pressman AR, Omar MA, Ettinger B (2006) Persistence with weekly alendronate therapy among postmenopausal women. Osteoporos Int 17:922–928CrossRefPubMed
13.
go back to reference Siris ES, Harris ST, Rosen CJ, Barr CE, Arvesen JN, Abbott TA, Silverman S (2006) Adherence to bisphosphonate therapy and fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases. Mayo Clin Proc 81:1013–1022CrossRefPubMed Siris ES, Harris ST, Rosen CJ, Barr CE, Arvesen JN, Abbott TA, Silverman S (2006) Adherence to bisphosphonate therapy and fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases. Mayo Clin Proc 81:1013–1022CrossRefPubMed
14.
go back to reference Cramer JA, Amonkar MM, Hebborn A, Altman R (2005) Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin 21:1453–1460CrossRefPubMed Cramer JA, Amonkar MM, Hebborn A, Altman R (2005) Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin 21:1453–1460CrossRefPubMed
15.
go back to reference Halpern R, Becker L, Iqbal SU, Kazis LE, Macarios D, Badamgarav E (2011) The association of adherence to osteoporosis therapies with fracture, all-cause medical costs, and all-cause hospitalizations: a retrospective claims analysis of female health plan enrollees with osteoporosis. J Manag Care Pharm 17:25–39PubMed Halpern R, Becker L, Iqbal SU, Kazis LE, Macarios D, Badamgarav E (2011) The association of adherence to osteoporosis therapies with fracture, all-cause medical costs, and all-cause hospitalizations: a retrospective claims analysis of female health plan enrollees with osteoporosis. J Manag Care Pharm 17:25–39PubMed
16.
go back to reference Huybrechts KF, Ishak KJ, Caro JJ (2006) Assessment of compliance with osteoporosis treatment and its consequences in a managed care population. Bone 38:922–928CrossRefPubMed Huybrechts KF, Ishak KJ, Caro JJ (2006) Assessment of compliance with osteoporosis treatment and its consequences in a managed care population. Bone 38:922–928CrossRefPubMed
17.
go back to reference Bauer DC, Black D, Ensrud K, Thompson D, Hochberg M, Nevitt M, Musliner T, Freedholm D (2000) Upper gastrointestinal tract safety profile of alendronate: the fracture intervention trial. Arch Intern Med 160:517–525CrossRefPubMed Bauer DC, Black D, Ensrud K, Thompson D, Hochberg M, Nevitt M, Musliner T, Freedholm D (2000) Upper gastrointestinal tract safety profile of alendronate: the fracture intervention trial. Arch Intern Med 160:517–525CrossRefPubMed
18.
go back to reference Taggart H, Bolognese MA, Lindsay R et al (2002) Upper gastrointestinal tract safety of risedronate: a pooled analysis of 9 clinical trials. Mayo Clin Proc 77:262–270CrossRefPubMed Taggart H, Bolognese MA, Lindsay R et al (2002) Upper gastrointestinal tract safety of risedronate: a pooled analysis of 9 clinical trials. Mayo Clin Proc 77:262–270CrossRefPubMed
19.
20.
go back to reference de Groen PC, Lubbe DF, Hirsch LJ, Daifotis A, Stephenson W, Freedholm D, Pryor-Tillotson S, Seleznick MJ, Pinkas H, Wang KK (1996) Esophagitis associated with the use of alendronate. N Engl J Med 335:1016–1021CrossRefPubMed de Groen PC, Lubbe DF, Hirsch LJ, Daifotis A, Stephenson W, Freedholm D, Pryor-Tillotson S, Seleznick MJ, Pinkas H, Wang KK (1996) Esophagitis associated with the use of alendronate. N Engl J Med 335:1016–1021CrossRefPubMed
21.
go back to reference Lanza FL, Hunt RH, Thomson AB, Provenza JM, Blank MA (2000) Endoscopic comparison of esophageal and gastroduodenal effects of risedronate and alendronate in postmenopausal women. Gastroenterology 119:631–638CrossRefPubMed Lanza FL, Hunt RH, Thomson AB, Provenza JM, Blank MA (2000) Endoscopic comparison of esophageal and gastroduodenal effects of risedronate and alendronate in postmenopausal women. Gastroenterology 119:631–638CrossRefPubMed
22.
go back to reference Hamilton B, McCoy K, Taggart H (2003) Tolerability and compliance with risedronate in clinical practice. Osteoporos Int 14:259–262CrossRefPubMed Hamilton B, McCoy K, Taggart H (2003) Tolerability and compliance with risedronate in clinical practice. Osteoporos Int 14:259–262CrossRefPubMed
23.
go back to reference Knopp-Sihota JA, Cummings GG, Homik J, Voaklander D (2013) The association between serious upper gastrointestinal bleeding and incident bisphosphonate use: a population-based nested cohort study. BMC Geriatr 13:36CrossRefPubMedPubMedCentral Knopp-Sihota JA, Cummings GG, Homik J, Voaklander D (2013) The association between serious upper gastrointestinal bleeding and incident bisphosphonate use: a population-based nested cohort study. BMC Geriatr 13:36CrossRefPubMedPubMedCentral
24.
go back to reference Vestergaard P, Schwartz K, Pinholt EM, Rejnmark L, Mosekilde L (2010) Gastric and esophagus events before and during treatment of osteoporosis. Calcif Tissue Int 86:110–115CrossRefPubMed Vestergaard P, Schwartz K, Pinholt EM, Rejnmark L, Mosekilde L (2010) Gastric and esophagus events before and during treatment of osteoporosis. Calcif Tissue Int 86:110–115CrossRefPubMed
25.
go back to reference Ettinger J, Pressman A, Schein J, Chan J, Silver P, N C (1998) Alendronate use among 812 women: prevalence, complaints, noncompliance with patient instructions. J Managed Care Pharm 488–492 Ettinger J, Pressman A, Schein J, Chan J, Silver P, N C (1998) Alendronate use among 812 women: prevalence, complaints, noncompliance with patient instructions. J Managed Care Pharm 488–492
26.
go back to reference Woo C, Gao G, Wade S, Hochberg MC (2010) Gastrointestinal side effects in postmenopausal women using osteoporosis therapy: 1-year findings in the POSSIBLE US study. Curr Med Res Opin 26:1003–1009CrossRefPubMed Woo C, Gao G, Wade S, Hochberg MC (2010) Gastrointestinal side effects in postmenopausal women using osteoporosis therapy: 1-year findings in the POSSIBLE US study. Curr Med Res Opin 26:1003–1009CrossRefPubMed
27.
go back to reference Yun H, Curtis JR, Guo L et al (2014) Patterns and predictors of osteoporosis medication discontinuation and switching among Medicare beneficiaries. BMC Musculoskelet Disord 15:112CrossRefPubMedPubMedCentral Yun H, Curtis JR, Guo L et al (2014) Patterns and predictors of osteoporosis medication discontinuation and switching among Medicare beneficiaries. BMC Musculoskelet Disord 15:112CrossRefPubMedPubMedCentral
28.
go back to reference Barrett-Connor E, Wade SW, Do TP, Satram-Hoang S, Stewart R, Gao G, Macarios D (2012) Treatment satisfaction and persistence among postmenopausal women on osteoporosis medications: 12-month results from POSSIBLE US. Osteoporos Int 23:733–741CrossRefPubMed Barrett-Connor E, Wade SW, Do TP, Satram-Hoang S, Stewart R, Gao G, Macarios D (2012) Treatment satisfaction and persistence among postmenopausal women on osteoporosis medications: 12-month results from POSSIBLE US. Osteoporos Int 23:733–741CrossRefPubMed
29.
go back to reference Modi A, Sen S, Adachi JD, et al. (2015) Rationale and design of MUSIC OS-EU: an international observational study of the treatment of postmenopausal women for osteoporosis in Europe and Canada. Clin Exp Rheumatol 33:in press Modi A, Sen S, Adachi JD, et al. (2015) Rationale and design of MUSIC OS-EU: an international observational study of the treatment of postmenopausal women for osteoporosis in Europe and Canada. Clin Exp Rheumatol 33:in press
30.
go back to reference Breuil V, Cortet B, Cotte FE, Arnould B, Dias-Barbosa C, Gaudin AF, Regnault A, Roborel de Climens A, Legrand E (2012) Validation of the adherence evaluation of osteoporosis treatment (ADEOS) questionnaire for osteoporotic post-menopausal women. Osteoporos Int 23:445–455CrossRefPubMed Breuil V, Cortet B, Cotte FE, Arnould B, Dias-Barbosa C, Gaudin AF, Regnault A, Roborel de Climens A, Legrand E (2012) Validation of the adherence evaluation of osteoporosis treatment (ADEOS) questionnaire for osteoporotic post-menopausal women. Osteoporos Int 23:445–455CrossRefPubMed
31.
go back to reference Flood EM, Beusterien KM, Green H, Shikiar R, Baran RW, Amonkar MM, Cella D (2006) Psychometric evaluation of the Osteoporosis Patient Treatment Satisfaction Questionnaire (OPSAT-Q), a novel measure to assess satisfaction with bisphosphonate treatment in postmenopausal women. Health Qual Life Outcomes 4:42CrossRefPubMedPubMedCentral Flood EM, Beusterien KM, Green H, Shikiar R, Baran RW, Amonkar MM, Cella D (2006) Psychometric evaluation of the Osteoporosis Patient Treatment Satisfaction Questionnaire (OPSAT-Q), a novel measure to assess satisfaction with bisphosphonate treatment in postmenopausal women. Health Qual Life Outcomes 4:42CrossRefPubMedPubMedCentral
32.
go back to reference Cheung K, Oemat M, M O, R R (2009) User guide: basic information on how to use EQ-5D Cheung K, Oemat M, M O, R R (2009) User guide: basic information on how to use EQ-5D
33.
go back to reference Silverman SL (2000) The osteoporosis assessment questionnaire (OPAQ): a reliable and valid disease-targeted measure of health related quality of life (HRQoL) in osteoporosis. Qual Life Res 9:767–774CrossRef Silverman SL (2000) The osteoporosis assessment questionnaire (OPAQ): a reliable and valid disease-targeted measure of health related quality of life (HRQoL) in osteoporosis. Qual Life Res 9:767–774CrossRef
34.
go back to reference Freemantle N, Cooper C, Roux C et al (2010) Baseline observations from the POSSIBLE EU(R) study: characteristics of postmenopausal women receiving bone loss medications. Arch Osteoporos 5:61–72CrossRefPubMedPubMedCentral Freemantle N, Cooper C, Roux C et al (2010) Baseline observations from the POSSIBLE EU(R) study: characteristics of postmenopausal women receiving bone loss medications. Arch Osteoporos 5:61–72CrossRefPubMedPubMedCentral
35.
go back to reference Penning-van Beest FJ, Goettsch WG, Erkens JA, Herings RM (2006) Determinants of persistence with bisphosphonates: a study in women with postmenopausal osteoporosis. Clin Ther 28:236–242CrossRefPubMed Penning-van Beest FJ, Goettsch WG, Erkens JA, Herings RM (2006) Determinants of persistence with bisphosphonates: a study in women with postmenopausal osteoporosis. Clin Ther 28:236–242CrossRefPubMed
36.
go back to reference Rossini M, Bianchi G, Di Munno O, Giannini S, Minisola S, Sinigaglia L, Adami S, Treatment of Osteoporosis in clinical Practice Study G (2006) Determinants of adherence to osteoporosis treatment in clinical practice. Osteoporos Int 17:914–921CrossRefPubMed Rossini M, Bianchi G, Di Munno O, Giannini S, Minisola S, Sinigaglia L, Adami S, Treatment of Osteoporosis in clinical Practice Study G (2006) Determinants of adherence to osteoporosis treatment in clinical practice. Osteoporos Int 17:914–921CrossRefPubMed
37.
go back to reference Tosteson AN, Do TP, Wade SW, Anthony MS, Downs RW (2010) Persistence and switching patterns among women with varied osteoporosis medication histories: 12-month results from POSSIBLE US. Osteoporos Int 21:1769–1780CrossRefPubMed Tosteson AN, Do TP, Wade SW, Anthony MS, Downs RW (2010) Persistence and switching patterns among women with varied osteoporosis medication histories: 12-month results from POSSIBLE US. Osteoporos Int 21:1769–1780CrossRefPubMed
Metadata
Title
Gastrointestinal symptoms and association with medication use patterns, adherence, treatment satisfaction, quality of life, and resource use in osteoporosis: baseline results of the MUSIC-OS study
Authors
A. Modi
S. Sen
J. D. Adachi
S. Adami
B. Cortet
A. L. Cooper
P. Geusens
D. Mellström
J. Weaver
J. P. van den Bergh
A. M. Nguyen
S. Sajjan
MUSIC-OS Study Group
Publication date
01-03-2016
Publisher
Springer London
Published in
Osteoporosis International / Issue 3/2016
Print ISSN: 0937-941X
Electronic ISSN: 1433-2965
DOI
https://doi.org/10.1007/s00198-015-3388-3

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