Randomized trial of intensive bisphosphonate treatment versus symptomatic management in Paget's disease of bone

Langston, Anne L, Campbell, Marion K, Fraser, William D, MacLennan, Graeme S, Selby, Peter L, Ralston, Stuart H, Walker-Bone, Karen and for the PRISM Trial Group, (2010) Randomized trial of intensive bisphosphonate treatment versus symptomatic management in Paget's disease of bone. Journal of Bone and Mineral Research (JBMR), 25 (1). pp. 20-31. ISSN 0884-0431

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Abstract

Bisphosphonates are widely regarded as the treatment of choice for Paget's disease of bone (PDB) because of their potent inhibitory effects on bone turnover, but the effects of bisphosphonate therapy on symptoms and complications of PDB have been little studied. Here we report the results of a randomized trial that compared the effects of symptomatic treatment with intensive bisphosphonate therapy in a cohort of 1324 patients with PDB who were followed up for a median of 3 years (range 2 to 5 years). The symptomatic treatment group was treated only if they had pagetic bone pain, for which they were first given analgesics or anti-inflammatory drugs, followed by bisphosphonates if they did not respond. The intensive group received repeat courses of bisphosphonates irrespective of symptoms with the aim of reducing and maintaining serum alkaline phosphatase (ALP) levels within the normal range. The endpoints were fracture, orthopedic surgery, quality of life, bone pain, and hearing thresholds. Serum ALP levels were significantly lower in the intensive treatment group than in with the symptomatic treatment group within 4 months of commencing treatment and remained lower throughout the study (p < .001). There was no difference between the groups in quality of life (as assessed by the SF36 questionnaire), in overall bodily pain, or in pagetic bone pain. Hearing thresholds, as assessed by audiometry did not change significantly and did not differ between the treatment groups. Clinical fractures occurred in 46 of 661 patients (7.0%) in the intensive treatment group compared with 49 of 663 patients (7.4%) in the symptomatic treatment group, and orthopedic surgery was required in 50 of 661 patients (7.3%) in the intensive treatment group and in 55 of 663 patients (8.3%) in the symptomatic treatment group. These differences were not significant. Subgroup analyses of patients with elevated ALP levels at baseline and those who did or did not receive bisphosphonates during the study yielded similar results to those in the study group as a whole. We conclude that striving to maintain normal ALP levels with intensive bisphosphonate therapy confers no clinical advantage over symptom-driven management in patients with established PDB. Neither management strategy had a significant beneficial impact on pain or quality of life (Clinical trial registration number ISRCTN12989577)

Item Type: Article
Additional Information: Impact Factor: 6.373 Karen Walker-Bone is part of the PRISM Trial Group and is not personally listed on author list
Schools and Departments: Brighton and Sussex Medical School > Clinical Medicine
Subjects: R Medicine
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Depositing User: Patricia Butler
Date Deposited: 15 Feb 2013 12:16
Last Modified: 15 Feb 2013 12:16
URI: http://sro.sussex.ac.uk/id/eprint/43786
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