Summary

In Paget's Disease, bisphosphonates are known to be effective at suppressing the "alkaline phosphatase" level (a biochemical marker used to monitor disease activity in Paget's disease). It is not known, however, whether the lowering effect on alkaline phosphatase is also accompanied by beneficial effects on the problems associated with Paget's, such as deafness, progression of arthritis, bone fractures, and reduced quality of life. To address this issue, the PRISM trial compared two different ways of treating Paget's disease ("symptomatic treatment" versus "intensive treatment"), in 1324 people over a five year period.  The symptomatic group were 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 to within the normal range. The endpoints were fracture, orthopaedic surgery, quality of life, bone pain, and hearing thresholds. The trial concluded that striving to maintain normal ALP levels with intensive bisphosphonate therapy confers no clinical advantage over symptom-driven management in patients with established PDB.

ContactPrism Trial Logo

Graeme MacLennan – g.maclennan@abdn.ac.uk

Status

Completed.

Publications

Referred Papers

Langston, A. L; McCallum, M.; Campbell, M. K.; Cameron, M.; Robertson, C.; & Ralston, S. H. An integrated approach to consumer representation and involvement in a multicentre randomised controlled trial. Clinical Trials 2005 2 (1) 80-87

Langston, A.L; Campbell , M.K.; Ralston, S.H. & Robertson, C. Protocol for a systematic review of Aminobisphosphonate vs. other active treatment for Paget's disease of the bone in adults. Cochrane Library 2004 Issue 4

Langston, A. L & Ralston, S. H. The management of Paget's disease of bone. Rheumatology 2004 43(8): 955-959

Langston AL, Campbell MK, Fraser WD, MacLennan G, Selby P, Ralston SH for the PRISM Trial Group.  Clinical Determinants of Quality of Life in Paget's Disease of Bone. Calcified Tissue International 2007;80(1):1-9.

Fayers P, Langston AL, Robertson C, PRISM Trial Group. Implicit self-comparisons against others could bias quality of life assessments. J Clin Epidemiol 2007;60:1034-1039.

Robertson C, Langston AL, Stapley S, McColl E, Campbell MK, Fraser WD, MacLennan GS, Selby PL, Ralston SH, Fayers P, PRISM Trial Group. Meaning behind measurement: self-comparisons affect responses to health related quality of life questionnaires. Qual Life Res 2009;18(2):221-230.

Langston AL, Campbell MK, Fraser WD, MacLennan GS, Selby PL, Ralston SH. Pragmatic Randomised Trial of Intensive Bisphosphonates versus  Symptomatic Management in established Paget's disease of Bone. J Bone Mineral Density 2010;25(1):20-31. 

Published Abstracts

Langston, AL; Ralston, SH; Campbell MK; Fraser, WD; Selby, PL & The PRISM Trial Group. The PRISM Trial: A randomised trial of intensive vs. symptomatic management for Paget's disease of the bone. Calcified Tissue International 2003 76(6): 782

Langston, AL ; Ralston, SH; Campbell MK; Fraser, WD; Selby, PL & The PRISM Trial Group. The PRISM Trial: A DNA repository sub-study. Calcified Tissue International 2003 76(6): 782

Langston, A; McCallum, M; Cameron, M; Campbell, MK & Ralston, SH Experiences of consumer organisation involvement in a UK multicentre randomised controlled trial. Controlled Clinical Trials 2003 24(3s): 155s - 156s

Langston AL , Campbell MK, Fraser WD, Selby PL, Ralston SH, and the PRISM Trial Group. Clinical criteria for the diagnosis of pagetic bone pain: survey of collaborating centres in the PRISM study.[abstract]. Calcif Tissue Int. 2005 ;76(6):481

Conference Presentations

Langston, AL; McCallum, M.; Campbell, M. K.; Cameron, M.; Robertson, C.; & Ralston, S. H. An integrated approach to consumer representation and involvement in a multicentre randomised controlled trial. INVOLVE - people at the heart of research , Nottingham , November 2004

Langston, AL; Ralston, SH; Campbell, MK; Fraser, WD; Selby PL. and the PRISM Trial Group. A large pragmatic randomised trial of intensive versus symptomatic therapy for Paget's disease of bone: the PRISM study. 1 st European Conference on Paget's disease of bone . Sienna, June 2004

Langston, AL; Hocking LJ; Lucas, G; Daroszewska, A & Ralston, SH. A Clinical trial of genetic testing and preventative treatment for SQSTM1 mediated Paget's disease of bone. 1 st European Conference on Paget's disease of bone . Sienna, June 2004

Langston, AL; McCallum, M; Cameron, M; Campbell, MK & Ralston, SH. An integrated approach to consumer involvement in a multicentre randomised controlled trial. International Society of Technology in Health Care 19 th Annual Meeting June 2003 .

Langston, AL; Ralston, SH; Campbell MK; Fraser, WD; Selby, PL & The PRISM Trial Group. The PRISM Trial: A randomised trial of intensive vs. symptomatic management for Paget's disease of the bone. International Symposium on Paget's disease of bone, Oxford July 2003

Langston, AL; Ralston, SH; Campbell MK; Fraser, WD; Selby, PL & The PRISM Trial Group. The PRISM Trial: A DNA repository sub-study. International Symposium on Paget's disease of bone, Oxford July 2003

Langston, AL; McCallum, M; Cameron, M; Campbell, MK & Ralston, SH Experiences of consumer organisation involvement in a UK multicentre randomised controlled trial. Society for Clinical Trials, London , July 2003