| Randomized trial of intensive bisphosphonate treatment versus symptomatic management in Paget's disease of bone. | |
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MedLine Citation:
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PMID: 19580457 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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). |
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Authors:
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Anne L Langston; Marion K Campbell; William D Fraser; Graeme S MacLennan; Peter L Selby; Stuart H Ralston; |
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Publication Detail:
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Type: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research Volume: 25 ISSN: 1523-4681 ISO Abbreviation: J. Bone Miner. Res. Publication Date: 2010 Jan |
Date Detail:
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Created Date: 2010-04-13 Completed Date: 2010-07-08 Revised Date: 2011-12-01 |
Medline Journal Info:
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Nlm Unique ID: 8610640 Medline TA: J Bone Miner Res Country: United States |
Other Details:
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Languages: eng Pagination: 20-31 Citation Subset: IM |
Copyright Information:
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2010 American Society for Bone and Mineral Research |
Affiliation:
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Rheumatic Diseases Unit, Institute of Genetics and Molecular Medicine University of Edinburgh, United Kingdom. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ISRCTN/ISRCTN12989577 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Alkaline Phosphatase / blood Bone Density Conservation Agents / administration & dosage, adverse effects, therapeutic use* Diphosphonates / administration & dosage, adverse effects, therapeutic use* Female Fractures, Bone / chemically induced, complications, surgery Hearing Loss / chemically induced, complications Humans Male Orthopedic Procedures Osteitis Deformans / blood, drug therapy*, enzymology Pain / chemically induced, complications Quality of Life |
| Grant Support | |
ID/Acronym/Agency:
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//Arthritis Research UK |
| Chemical | |
Reg. No./Substance:
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0/Bone Density Conservation Agents; 0/Diphosphonates; EC 3.1.3.1/Alkaline Phosphatase |
| Investigator | |
Investigator/Affiliation:
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Vera Herd / ; Stuart H Ralston / ; Rose McIver / ; Mashood Siddiqi / ; Ashok Bhalla / ; Diana Cochran / ; Sharon Grieve / ; Sara Mills / ; Katrina Hughes / ; Richard Wallace / ; Neil Gittoes / ; Liz McGregor / ; Keatley R H Adams / ; Mary Adams / ; Vera Herd / ; Graham Leese / ; Ellen Malcolm / ; Sarah Hailwood / ; Paul Ryan / ; Gwen Worcester / ; Alastair McLellan / ; Debby Nelson / ; Allan Fairclough / ; Richard Reece / ; Fiona McGhie / ; Malcolm Steven / ; Annie Cooper / ; Stuart H Ralston / ; Margaret Coe / ; S Javed Iqbal / ; Geraldine McHugh / ; William D Fraser / ; Ya-Wen Jessica Huang / ; Margaret Little / ; Vinita Mishra / ; Nicola Wherly / ; Merle Maddison / ; Lyn Vaterlaws / ; Ignac Fogelman / ; Nina Prescod / ; Rama Chandra / ; Tina Mangion / ; Caje Moniz / ; Susan Harrison / ; Peter L Selby / ; John N Fordham / ; Val Lunn / ; Dawn Youll / ; Roger Francis / ; Jane Leeder / ; David G I Scott / ; David Hosking / ; Pat San / ; Michael Davie / ; Teresa Jones / ; Dawn Pugh / ; Matthew Brown / ; Vicky Toghill / ; John Wass / ; Jo Young / ; Roz Broadbent / ; Mike Stone / ; Jane Turton / ; Charles Hutton / ; Maggie Jolly / ; Julia Taylor / ; Paul Thompson / ; Kuntal Chakravarty / ; Christine Heron / ; Christopher Kelsey / ; Sylvia Mercer / ; Terence W O'Neill / ; Jenny Cliffe / ; Linda Kersh / ; Eugene McCloskey / ; Trish Byng / ; Janet Cushnaghan / ; Cyrus Cooper / ; Nick Harvey / ; Karen Walker-Bone / ; Richard Keen / ; Maggie Partridge / ; Lynne Kerton / ; Elizabeth Price / ; Jill Lomas / ; Peter Winocour / ; E George / ; T D Kennedy / ; Anthony Lake / ; Nita Beacham / ; Clare Buckley / ; Jenny Knight / ; Lisa Martin / ; T G Palferman / |
| Comments/Corrections | |
Comment In:
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J Bone Miner Res. 2010 Jun;25(6):1463-4; author reply 1465-6
[PMID:
20499373
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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