Back Pain/etiology/prevention & control; Bone Density Conservation Agents/therapeutic use; Double-Blind Method; Female; Humans; Male; Osteoporosis/complications/drug therapy; Randomized Controlled Trials as Topic; Spinal Fractures/etiology/prevention & control; Teriparatide/therapeutic use
Abstract :
[en] INTRODUCTION: Teriparatide [rhPTH (1-34)] reduces fracture risk, and in a published meta-analysis of clinical trials, teriparatide-treated patients had reduced incidence of back pain relative to placebo or to antiresorptive drugs. The aim of this study was to evaluate back pain in teriparatide-treated versus comparator-treated patients during an interval including controlled clinical trials plus 30 months of additional follow-up. METHODS: A meta-analysis of four completed randomized, double-blinded trials of teriparatide [rhPTH (1-34)] versus comparator was performed. A multivariate Cox proportional hazards model was used to assess the heterogeneity of results and to estimate the relative risk of back pain. RESULTS: Patients in the pooled teriparatide group had reduced risk for any back pain [relative risk, 0.73 (95% CI, 0.61-0.87)], moderate or severe back pain [0.72 (0.58-0.89)], and severe back pain [0.39 (0.25-0.61)] compared with pooled controls, from initiation of the study drug through the end of follow-up. Sensitivity analysis showed that the results were robust to the removal of each individual trial from the meta-analysis. Separate meta-analyses comparing teriparatide versus placebo or antiresorptive drugs gave similar results. CONCLUSIONS: Teriparatide-treated patients had a reduced incidence of back pain versus those receiving a comparator during an observation encompassing clinical trials plus 30 months of posttreatment observation.
Disciplines :
Endocrinology, metabolism & nutrition General & internal medicine
Author, co-author :
Nevitt, M. C.
Chen, P.
Kiel, D. P.
Reginster, Jean-Yves ; Université de Liège - ULiège > Département des sciences de la santé publique > Epidémiologie et santé publique
Dore, R. K.
Zanchetta, J. R.
Glass, E. V.
Krege, J. H.
Language :
English
Title :
Reduction in the risk of developing back pain persists at least 30 months after discontinuation of teriparatide treatment: a meta-analysis.
Publication date :
2006
Journal title :
Osteoporosis International
ISSN :
0937-941X
eISSN :
1433-2965
Publisher :
Springer Science & Business Media B.V., Godalming, United Kingdom
Riggs BL, Melton LJ III (1995) The worldwide problem of osteoporosis: insights afforded by epidemiology. Bone 17(5 Suppl):505S-511S
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 (10):793-800
Cooper C, Atkinson EJ, O'Fallon WM (1992) Incidence of clinically diagnosed vertebral fractures: a population-based study in Rochester, Minnesota, 1985-1989. J Bone Miner Res 7:221-227
Fink HA, Milavetz DL, Palermo L et al (2005) What proportion of incident radiographic vertebral deformities is clinically diagnosed and vice versa? J Bone Miner Res 20:1216-1222
Silverman SL, Piziak VK, Chen P et al (2005) Relationship of health related quality of life to prevalent and new or worsening back pain in postmenopausal women with osteoporosis. J Rheumatol 32(12):2405-2409
Genant HK, Halse J, Briney WG et al (2005) The effects of teriparatide on the incidence of back pain in postmenopausal women with osteoporosis. Curr Med Res Opin 21(7):1027-1034
Gold DT (1996) The clinical impact of vertebral fractures: quality of life in women with osteoporosis. Bone 18(3 Suppl):185S-189S
Edmond SL, Kiel DP, Samelson EJ et al (2005) Vertebral deformity, back symptoms, and functional limitations among older women: the Framingham study. Osteoporos Int 6(9):1086-1095
Ismail AA, Cooper C, Felsenberg D et al (1999) Number and type of vertebral deformities: epidemiological characteristics and relation to back pain and height loss. European vertebral osteoporosis study group. Osteoporos Int 9(3):206-213
Neer RM, Arnaud CD, Zanchetta JR et al (2001) Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 344(19):1434-1441
Lindsay R, Scheele WH, Neer R et al (2004) Sustained vertebral fracture risk reduction after withdrawal of teriparatide in postmenopausal women with osteoporosis. Arch Intern Med 164 (18):2024-2030
Miller PD, Shergy WJ, Body JJ et al (2005) Longterm reduction of back pain risk in women with osteoporosis treated with teriparatide compared with alendronate. J Rheumatol 32 (8):1556-1562
Nevitt MC, Chen P, Dore RK et al (2006) Reduced risk of back pain following teriparatide treatment: a meta-analysis. Osteoporos Int 17(2):273-280
Orwoll ES, Scheele WH, Paul S et al (2003) The effect of teriparatide [human parathyroid hormone (1-34)] therapy on bone density in men with osteoporosis. J Bone Miner Res 18 (1):9-17
Body JJ, Gaich GA, Scheele WH et al (2002) A randomized double-blind trial to compare the efficacy of teriparatide [recombinant human parathyroid hormone (1-34)] with alendronate in postmenopausal women with osteoporosis. J Clin Endocrinol Metab 87(10):4528-4535
Ste-Marie LG, Schwartz SL, Hossain AM et al (2006) Effect of teriparatide [rh parathyroid hormone (1-34)] on bone density when given to postmenopausal women receiving hormone replacement therapy. J Bone Miner Res 21(2):283-291
Kaufman JM, Orwoll E, Goemaere S et al (2005) Teriparatide effects on vertebral fractures and bone mineral density in men with osteoporosis: treatment and discontinuation of therapy. Osteoporos Int 16(5):510-516
Gold DT (1996) The clinical impact of vertebral fractures: quality of life in women with osteoporosis. Bone 18(suppl 3):185-189
Cooper C (1993) Epidemiology and public health impact of osteoporosis. Clin Rheumatol 7:459-477
Andersson GB (1999) Epidemiological features of chronic low-back pain. Lancet 354:581-585
