Preliminary evidence for a structural benefit of the new bisphosphonate zoledronic acid in early rheumatoid arthritis

Objective Bisphosphonates inhibit osteoclast activity, which is central to the development of bone damage in rheumatoid arthritis (RA). The aim of this study was to assess whether treatment with zoledronic acid, compared with placebo, could achieve a ≥50% reduction in the development of new erosions...

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Veröffentlicht in:Arthritis and rheumatism 2006-05, Vol.54 (5), p.1410-1414
Hauptverfasser: Jarrett, Stephen J., Conaghan, Philip G., Sloan, Victor S., Papanastasiou, Philemon, Ortmann, Christine‐Elke, O'Connor, Philip J., Grainger, Andrew J., Emery, Paul
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container_end_page 1414
container_issue 5
container_start_page 1410
container_title Arthritis and rheumatism
container_volume 54
creator Jarrett, Stephen J.
Conaghan, Philip G.
Sloan, Victor S.
Papanastasiou, Philemon
Ortmann, Christine‐Elke
O'Connor, Philip J.
Grainger, Andrew J.
Emery, Paul
description Objective Bisphosphonates inhibit osteoclast activity, which is central to the development of bone damage in rheumatoid arthritis (RA). The aim of this study was to assess whether treatment with zoledronic acid, compared with placebo, could achieve a ≥50% reduction in the development of new erosions on magnetic resonance imaging (MRI) in patients with early RA. Methods In this proof‐of‐concept study, 39 patients with early RA and clinical synovitis of the hand/wrist were randomized to receive infusions with either zoledronic acid (5 mg) or placebo, administered at baseline and week 13. Patients in both groups received methotrexate (MTX) at a dosage of 7.5–20 mg/week. MRI and plain radiography were performed at baseline and week 26. Results At week 26, the mean ± SD change in MRI hand and wrist erosions was 61% lower in the zoledronic acid group compared with the placebo group (0.9 ± 1.63 versus 2.3 ± 3.09; P = 0.176). The mean ± SD increase in the number of hand and wrist bones with erosions was 0.3 ± 0.75 for zoledronic acid compared with 1.4 ± 1.77 for placebo (P = 0.029). The proportion of patients in whom new MRI‐visualized bone edema developed was smaller in the zoledronic acid group compared with the placebo group (33% versus 58%; P = 0.121). The zoledronic acid group had a mean change in the number of radiographic erosions of 0.1 compared with 0.5 for the placebo group (P = 0.677). The safety profile of zoledronic acid was similar to that of placebo. Conclusion The results of this study suggest a structural benefit associated with zoledronic acid therapy in patients with RA, as demonstrated by consistent results in structural end points in favor of zoledronic acid plus MTX compared with MTX alone.
doi_str_mv 10.1002/art.21824
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The aim of this study was to assess whether treatment with zoledronic acid, compared with placebo, could achieve a ≥50% reduction in the development of new erosions on magnetic resonance imaging (MRI) in patients with early RA. Methods In this proof‐of‐concept study, 39 patients with early RA and clinical synovitis of the hand/wrist were randomized to receive infusions with either zoledronic acid (5 mg) or placebo, administered at baseline and week 13. Patients in both groups received methotrexate (MTX) at a dosage of 7.5–20 mg/week. MRI and plain radiography were performed at baseline and week 26. Results At week 26, the mean ± SD change in MRI hand and wrist erosions was 61% lower in the zoledronic acid group compared with the placebo group (0.9 ± 1.63 versus 2.3 ± 3.09; P = 0.176). The mean ± SD increase in the number of hand and wrist bones with erosions was 0.3 ± 0.75 for zoledronic acid compared with 1.4 ± 1.77 for placebo (P = 0.029). The proportion of patients in whom new MRI‐visualized bone edema developed was smaller in the zoledronic acid group compared with the placebo group (33% versus 58%; P = 0.121). The zoledronic acid group had a mean change in the number of radiographic erosions of 0.1 compared with 0.5 for the placebo group (P = 0.677). The safety profile of zoledronic acid was similar to that of placebo. Conclusion The results of this study suggest a structural benefit associated with zoledronic acid therapy in patients with RA, as demonstrated by consistent results in structural end points in favor of zoledronic acid plus MTX compared with MTX alone.</description><identifier>ISSN: 0004-3591</identifier><identifier>EISSN: 1529-0131</identifier><identifier>DOI: 10.1002/art.21824</identifier><identifier>PMID: 16645968</identifier><identifier>CODEN: ARHEAW</identifier><language>eng</language><publisher>Hoboken: Wiley Subscription Services, Inc., A Wiley Company</publisher><subject>Adult ; Aged ; Arthritis, Rheumatoid - diagnosis ; Arthritis, Rheumatoid - drug therapy ; Biological and medical sciences ; Bone Density Conservation Agents - therapeutic use ; Bones, joints and connective tissue. Antiinflammatory agents ; Diphosphonates - therapeutic use ; Diseases of the osteoarticular system ; Double-Blind Method ; Female ; Humans ; Imidazoles - therapeutic use ; Inflammatory joint diseases ; Magnetic Resonance Imaging ; Male ; Medical sciences ; Middle Aged ; Pharmacology. 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The aim of this study was to assess whether treatment with zoledronic acid, compared with placebo, could achieve a ≥50% reduction in the development of new erosions on magnetic resonance imaging (MRI) in patients with early RA. Methods In this proof‐of‐concept study, 39 patients with early RA and clinical synovitis of the hand/wrist were randomized to receive infusions with either zoledronic acid (5 mg) or placebo, administered at baseline and week 13. Patients in both groups received methotrexate (MTX) at a dosage of 7.5–20 mg/week. MRI and plain radiography were performed at baseline and week 26. Results At week 26, the mean ± SD change in MRI hand and wrist erosions was 61% lower in the zoledronic acid group compared with the placebo group (0.9 ± 1.63 versus 2.3 ± 3.09; P = 0.176). The mean ± SD increase in the number of hand and wrist bones with erosions was 0.3 ± 0.75 for zoledronic acid compared with 1.4 ± 1.77 for placebo (P = 0.029). The proportion of patients in whom new MRI‐visualized bone edema developed was smaller in the zoledronic acid group compared with the placebo group (33% versus 58%; P = 0.121). The zoledronic acid group had a mean change in the number of radiographic erosions of 0.1 compared with 0.5 for the placebo group (P = 0.677). The safety profile of zoledronic acid was similar to that of placebo. Conclusion The results of this study suggest a structural benefit associated with zoledronic acid therapy in patients with RA, as demonstrated by consistent results in structural end points in favor of zoledronic acid plus MTX compared with MTX alone.</description><subject>Adult</subject><subject>Aged</subject><subject>Arthritis, Rheumatoid - diagnosis</subject><subject>Arthritis, Rheumatoid - drug therapy</subject><subject>Biological and medical sciences</subject><subject>Bone Density Conservation Agents - therapeutic use</subject><subject>Bones, joints and connective tissue. Antiinflammatory agents</subject><subject>Diphosphonates - therapeutic use</subject><subject>Diseases of the osteoarticular system</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Imidazoles - therapeutic use</subject><subject>Inflammatory joint diseases</subject><subject>Magnetic Resonance Imaging</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. 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Antiinflammatory agents</topic><topic>Diphosphonates - therapeutic use</topic><topic>Diseases of the osteoarticular system</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Imidazoles - therapeutic use</topic><topic>Inflammatory joint diseases</topic><topic>Magnetic Resonance Imaging</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacology. 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The aim of this study was to assess whether treatment with zoledronic acid, compared with placebo, could achieve a ≥50% reduction in the development of new erosions on magnetic resonance imaging (MRI) in patients with early RA. Methods In this proof‐of‐concept study, 39 patients with early RA and clinical synovitis of the hand/wrist were randomized to receive infusions with either zoledronic acid (5 mg) or placebo, administered at baseline and week 13. Patients in both groups received methotrexate (MTX) at a dosage of 7.5–20 mg/week. MRI and plain radiography were performed at baseline and week 26. Results At week 26, the mean ± SD change in MRI hand and wrist erosions was 61% lower in the zoledronic acid group compared with the placebo group (0.9 ± 1.63 versus 2.3 ± 3.09; P = 0.176). The mean ± SD increase in the number of hand and wrist bones with erosions was 0.3 ± 0.75 for zoledronic acid compared with 1.4 ± 1.77 for placebo (P = 0.029). The proportion of patients in whom new MRI‐visualized bone edema developed was smaller in the zoledronic acid group compared with the placebo group (33% versus 58%; P = 0.121). The zoledronic acid group had a mean change in the number of radiographic erosions of 0.1 compared with 0.5 for the placebo group (P = 0.677). The safety profile of zoledronic acid was similar to that of placebo. Conclusion The results of this study suggest a structural benefit associated with zoledronic acid therapy in patients with RA, as demonstrated by consistent results in structural end points in favor of zoledronic acid plus MTX compared with MTX alone.</abstract><cop>Hoboken</cop><pub>Wiley Subscription Services, Inc., A Wiley Company</pub><pmid>16645968</pmid><doi>10.1002/art.21824</doi><tpages>5</tpages></addata></record>
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subjects Adult
Aged
Arthritis, Rheumatoid - diagnosis
Arthritis, Rheumatoid - drug therapy
Biological and medical sciences
Bone Density Conservation Agents - therapeutic use
Bones, joints and connective tissue. Antiinflammatory agents
Diphosphonates - therapeutic use
Diseases of the osteoarticular system
Double-Blind Method
Female
Humans
Imidazoles - therapeutic use
Inflammatory joint diseases
Magnetic Resonance Imaging
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
title Preliminary evidence for a structural benefit of the new bisphosphonate zoledronic acid in early rheumatoid arthritis
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