Abstract
Summary
Strontium ranelate reduces the risk of fracture in post-menopausal osteoporotic women with prevalent fractures for whom quality of life is severely impaired. The SOTI study, which used the SF-36® questionnaire and disease-specific QUALIOST® module, demonstrated that treatment with strontium ranelate improved osteoporotic women’s quality of life compared with placebo.
Introduction
The Spinal Osteoporosis Therapeutic Intervention (SOTI) study demonstrated the effect of orally administered strontium ranelate versus placebo on the incidence of new vertebral fractures and compared impact on quality of life (QoL).
Methods
QoL was assessed 6 monthly over 3 years using the QUALIOST® and SF-36® questionnaires in post-menopausal osteoporotic women with prevalent fracture taking strontium ranelate or placebo 2 g/day. A total of 1,240 women were included (strontium ranelate: n = 618 and placebo: n = 622).
Results
The QUALIOST® total score decreased in the strontium ranelate group, indicating preserved QoL compared with a deterioration in the placebo group (P = 0.016). Strontium ranelate patients had reduced QUALIOST® emotional and physical dimension scores (P = 0.019 and 0.032, respectively, versus placebo), indicating beneficial effects on emotional and physical functioning. There was a trend towards better SF-36® scores in the strontium ranelate group, although there were no significant between-group differences. More strontium ranelate patients (+ 31%) were free from back pain over 3 years versus placebo (P = 0.005), with a significant effect from the first year of treatment (P = 0.023).
Conclusion
Strontium ranelate has beneficial effects on QoL in women with post-menopausal osteoporosis compared with placebo.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Consensus Development Conference report (1993) Diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med 94:646–650
Nevitt MC, Ettinger B, Black DM et al (1998) The association of radiographically detected vertebral fractures with back pain and function: a prospective study. Ann Intern Med 128:793–800
Ettinger B, Black DM, Nevitt MC et al (1992) Contribution of vertebral deformities to chronic back pain and disability. The Study of Osteoporotic Fractures Research Group. J Bone Miner Res 7:449–456
The European Prospective Osteoporosis Study Group (2002) Incidence of vertebral fracture in Europe: results from the European Prospective Osteoporosis Study (EPOS). J Bone Miner Res 17:716–724
Silverman SL, Minshall ME, Shen W et al (2001) The relationship of health-related quality of life to prevalent and incident vertebral fractures in postmenopausal women with osteoporosis: results from the Multiple Outcomes of Raloxifene Evaluation Study. Arthritis Rheum 44:2611–2619
Cook DJ, Guyatt GH, Adachi JD et al (1997) Measuring quality of life in women with osteoporosis. Osteoporos Int 7:478–487
Chassany O, Sagnier P, Marquis P et al (2002) Patient-reported outcomes: the example of health-related quality of life – a European guidance document for the improved integration of health-related quality of life assessment in the drug regulatory process. Drug Inf J 36:209–238
Marquis P, Cialdella P, de la Loge C (2001) Development and validation of a specific quality of life module in post-menopausal women with osteoporosis: the QUALIOST. Qual Life Res 10:555–566
Ware JE, Snow KK, Kosinski MK et al (1993) SF-36 Health Survey, Manual and Interpretation Guide. The Health Institute, New England Medical Center, Boston, Massachussets
De la Loge C, Sullivan K, Pinkney R et al (2005) Cross-cultural validation and analysis of responsiveness of the QUALIOST®: QUAlity of Life questionnaire In OSTeoporosis. Health Qual Life Outcomes 3:69
Meunier PJ, Roux C, Seeman E (2004) The effects of strontium ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis. N Engl J Med 350:459–468
Reginster JY, Spector TD, Badurski J et al (2002) A short-term run-in study can significantly contribute to increasing the quality of long-term osteoporosis trials. The Strontium ranelate Phase 3 program. Osteoporos Int 13 (suppl 1): P85MO
Ware JE, Kosinski MK, Keller SD (1994) SF-36 Physical and Mental Health Summary Scales: A User’s Manual. The Health Institute, New England Medical Center, Boston, MA
Cook DJ, Guyatt GH, Adachi JD et al (1993) Quality of life issues in women with vertebral fractures due to osteoporosis. Arthritis Rheum 36:750–756
Roberto KA (1988) Women with osteoporosis: the role of the family and service community. Gerontologist 28:224–228
Kotz K, Deleger S, Cohen R et al (2004) Osteoporosis and health-related quality-of-life outcomes in the Alameda County Study population. Prev Chronic Dis 1:A05.
Lips P, Cooper C, Agnusdei D et al (1997) Quality of life as an outcome in the treatment of Osteoporosis: The development of a questionnaire for Quality of Life by the European Foundation of Osteoporosis. 7:36–38
Fechtenbaum J, Cropet C, Kolta S et al (2005) The severity of vertebral fractures and health-related quality of life in osteoporotic postmenopausal women. Osteoporosis Int 16:2175–2179
Jenkinson C, Stewart-Brown S, Petersen S et al (1999) Assessment of the SF-36 version 2 in the United Kingdom. J Epidemiol Community Health 53:46–50
Dursun N, Dursun E, Yalcin S (2001) Comparison of alendronate, calcitonin and calcium treatment in postmenopausal osteoporosis. Int J Clin Pract 55:505–509
Semler J, Raue F, Grauer A et al (2002) Risedronate improves quality of life in women with osteoporosis after 6 months: results from a perspective cohort study. J Back Musculoskeletal Rehabil 17:S378
Oleksik AM, Ewing S, Shen W et al (2005) Impact of incident vertebral fractures on health related quality of life (HRQOL) in postmenopausal women with prevalent vertebral fractures. Osteoporos Int 16:861–870
Nevitt MC, Chen P, Dore RK et al (2006). Reduced risk of back pain following teriparatide treatment: a meta-analysis. Osteoporosis Int 17:273–280
European Summary of Product characteristics 2005 Available at http://www.servier.com/pro/osteoporose/protelos/protelos_spc.asp. Last accessed on 22 June 2006
Acknowledgements
The authors gratefully acknowledge the support of the investigators and participants in the SOTI study. This study was supported by SERVIER.
Author information
Authors and Affiliations
Corresponding author
Additional information
QUALIOST® is protected by copyright and trademark registrations, with all rights reserved to SERVIER. Do not use without permission. For information on or permission to use QUALIOST®, please contact the Mapi Research Trust, 27 rue de la Villette, 69003 Lyon, France (tel.: +33-4-72136575; e-mail: trust@mapi.fr; websites: www.mapi-trust.org , www.proqolid.org )
Rights and permissions
About this article
Cite this article
Marquis, P., Roux, C., de la Loge, C. et al. Strontium ranelate prevents quality of life impairment in post-menopausal women with established vertebral osteoporosis. Osteoporos Int 19, 503–510 (2008). https://doi.org/10.1007/s00198-007-0464-3
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00198-007-0464-3