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Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: Efficacy and safety results from a randomized open-label study

Identifieur interne : 004216 ( Main/Exploration ); précédent : 004215; suivant : 004217

Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: Efficacy and safety results from a randomized open-label study

Auteurs : C. Roux [France] ; L. C. Hofbauer [Allemagne] ; P. R. Ho [États-Unis] ; J. D. Wark [Australie] ; M. C. Zillikens [Pays-Bas] ; A. Fahrleitner-Pammer [Autriche] ; F. Hawkins [Espagne] ; M. Micaelo [Portugal] ; S. Minisola [Italie] ; N. Papaioannou [Grèce] ; M. Stone [Royaume-Uni] ; I. Ferreira [États-Unis] ; S. Siddhanti [États-Unis] ; R. B. Wagman [États-Unis] ; J. P. Brown [Canada]

Source :

RBID : Pascal:14-0062999

Descripteurs français

English descriptors

Abstract

Denosumab has been shown to reduce new vertebral, nonvertebral, and hip fractures in postmenopausal women with osteoporosis. In subjects who were treatment-naïve or previously treated with alendronate, denosumab was associated with greater gains in bone mineral density (BMD) and decreases in bone turnover markers when compared with alendronate-treated subjects. This trial was designed to compare the efficacy and safety of denosumab with risedronate over 12 months in postmenopausal women who transitioned from daily or weekly alendronate treatment and were considered to be suboptimally adherent to therapy. In this randomized, open-label study, postmenopausal women aged ≥55 years received denosumab 60 mg subcutaneously every 6 months or risedronate 150 mg orally every month for 12 months. Endpoints included percentage change from baseline in total hip BMD (primary endpoint), femoral neck, and lumbar spine BMD at month 12, and percentage change from baseline in sCTX-1 at months 1 and 6. Safety was also assessed. A total of 870 subjects were randomized (435, risedronate; 435, denosumab) who had a mean (SD) age of 67.7 (6.9) years, mean (SD) BMD T-scores of - 1.6 (0.9), - 1.9 (0.7), and - 2.2 (1.2) at the total hip, femoral neck, and lumbar spine, respectively, and median sCTX-1 of 0.3 ng/mL at baseline. At month 12, denosumab significantly increased BMD compared with risedronate at the total hip (2.0% vs 0.5%), femoral neck (1.4% vs 0%), and lumbar spine (3.4% vs 1.1 %; p < 0.0001 at all sites). Denosumab significantly decreased sCTX-l compared with risedronate at month 1 (median change from baseline of - 78% vs -17%; p < 0.0001) and month 6 (-61% vs - 23%; p < 0.0001). Overall and serious adverse events were similar between groups. In postmenopausal women who were suboptimally adherent to alendronate therapy, transitioning to denosumab was well tolerated and more effective than risedronate in increasing BMD and reducing bone turnover.


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Le document en format XML

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<name sortKey="Brown, J P" sort="Brown, J P" uniqKey="Brown J" first="J. P." last="Brown">J. P. Brown</name>
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<s1>Laval University, CHU de Québec (CHUL), Room S-763, 2705 Laurier boulevard</s1>
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<country>Canada</country>
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<title xml:lang="en" level="a">Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: Efficacy and safety results from a randomized open-label study</title>
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<s1>Paris Descartes University, Department of Rheumatology, Cochin Hospital, 27 rue du Faubourg Saint Jacques</s1>
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<s1>Dresden University of Technology Medical Center, Division of Endocrinology and Bone Diseases, Fetscherstr. 74</s1>
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<name sortKey="Wark, J D" sort="Wark, J D" uniqKey="Wark J" first="J. D." last="Wark">J. D. Wark</name>
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<s1>The University of Melbourne, Department of Medicine (Royal Melbourne Hospital), Head, Bone & Mineral Medicine</s1>
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<settlement type="city">Melbourne</settlement>
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<s1>Department of Internal Medicine, Erasmus Medical Center</s1>
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<s3>NLD</s3>
<sZ>5 aut.</sZ>
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<country>Pays-Bas</country>
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<settlement type="city">Rotterdam</settlement>
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<name sortKey="Fahrleitner Pammer, A" sort="Fahrleitner Pammer, A" uniqKey="Fahrleitner Pammer A" first="A." last="Fahrleitner-Pammer">A. Fahrleitner-Pammer</name>
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<country>Portugal</country>
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<name sortKey="Minisola, S" sort="Minisola, S" uniqKey="Minisola S" first="S." last="Minisola">S. Minisola</name>
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<name sortKey="Papaioannou, N" sort="Papaioannou, N" uniqKey="Papaioannou N" first="N." last="Papaioannou">N. Papaioannou</name>
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<country>Grèce</country>
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<name sortKey="Stone, M" sort="Stone, M" uniqKey="Stone M" first="M." last="Stone">M. Stone</name>
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<s1>Bone Research Unit, Cardiff University Academic Centre, University Hospital of Llandough</s1>
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<name sortKey="Ferreira, I" sort="Ferreira, I" uniqKey="Ferreira I" first="I." last="Ferreira">I. Ferreira</name>
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<s1>Amgen Inc.</s1>
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<name sortKey="Siddhanti, S" sort="Siddhanti, S" uniqKey="Siddhanti S" first="S." last="Siddhanti">S. Siddhanti</name>
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<inist:fA14 i1="03">
<s1>Amgen Inc.</s1>
<s2>Thousand Oaks, CA</s2>
<s3>USA</s3>
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<sZ>13 aut.</sZ>
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</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Amgen Inc.</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Wagman, R B" sort="Wagman, R B" uniqKey="Wagman R" first="R. B." last="Wagman">R. B. Wagman</name>
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<inist:fA14 i1="03">
<s1>Amgen Inc.</s1>
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<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
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<country>États-Unis</country>
<wicri:noRegion>Amgen Inc.</wicri:noRegion>
</affiliation>
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<name sortKey="Brown, J P" sort="Brown, J P" uniqKey="Brown J" first="J. P." last="Brown">J. P. Brown</name>
<affiliation wicri:level="1">
<inist:fA14 i1="12">
<s1>Laval University, CHU de Québec (CHUL), Room S-763, 2705 Laurier boulevard</s1>
<s2>Québec City, QC G1V 4G2</s2>
<s3>CAN</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Québec City, QC G1V 4G2</wicri:noRegion>
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<title level="j" type="main">Bone : (New York, NY)</title>
<title level="j" type="abbreviated">Bone : (NY NY)</title>
<idno type="ISSN">8756-3282</idno>
<imprint>
<date when="2014">2014</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">Bone : (New York, NY)</title>
<title level="j" type="abbreviated">Bone : (NY NY)</title>
<idno type="ISSN">8756-3282</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Alendronic acid</term>
<term>Antiosteoclastic agent</term>
<term>Antiosteoporotic</term>
<term>Bone mineral density</term>
<term>Bone remodeling</term>
<term>Denosumab</term>
<term>Immunomodulator</term>
<term>Morphology</term>
<term>Osteoporosis</term>
<term>Postmenopause</term>
<term>Risedronic acid</term>
<term>Toxicity</term>
<term>Treatment</term>
<term>Woman</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Dénosumab</term>
<term>Acide risédronique</term>
<term>Acide alendronique</term>
<term>Postménopause</term>
<term>Femme</term>
<term>Traitement</term>
<term>Toxicité</term>
<term>Ostéoporose</term>
<term>Densité minérale osseuse</term>
<term>Remodelage osseux</term>
<term>Morphologie</term>
<term>Immunomodulateur</term>
<term>Antiostéoporotique</term>
<term>Antiostéoclastique</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Femme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Denosumab has been shown to reduce new vertebral, nonvertebral, and hip fractures in postmenopausal women with osteoporosis. In subjects who were treatment-naïve or previously treated with alendronate, denosumab was associated with greater gains in bone mineral density (BMD) and decreases in bone turnover markers when compared with alendronate-treated subjects. This trial was designed to compare the efficacy and safety of denosumab with risedronate over 12 months in postmenopausal women who transitioned from daily or weekly alendronate treatment and were considered to be suboptimally adherent to therapy. In this randomized, open-label study, postmenopausal women aged ≥55 years received denosumab 60 mg subcutaneously every 6 months or risedronate 150 mg orally every month for 12 months. Endpoints included percentage change from baseline in total hip BMD (primary endpoint), femoral neck, and lumbar spine BMD at month 12, and percentage change from baseline in sCTX-1 at months 1 and 6. Safety was also assessed. A total of 870 subjects were randomized (435, risedronate; 435, denosumab) who had a mean (SD) age of 67.7 (6.9) years, mean (SD) BMD T-scores of - 1.6 (0.9), - 1.9 (0.7), and - 2.2 (1.2) at the total hip, femoral neck, and lumbar spine, respectively, and median sCTX-1 of 0.3 ng/mL at baseline. At month 12, denosumab significantly increased BMD compared with risedronate at the total hip (2.0% vs 0.5%), femoral neck (1.4% vs 0%), and lumbar spine (3.4% vs 1.1 %; p < 0.0001 at all sites). Denosumab significantly decreased sCTX-l compared with risedronate at month 1 (median change from baseline of - 78% vs -17%; p < 0.0001) and month 6 (-61% vs - 23%; p < 0.0001). Overall and serious adverse events were similar between groups. In postmenopausal women who were suboptimally adherent to alendronate therapy, transitioning to denosumab was well tolerated and more effective than risedronate in increasing BMD and reducing bone turnover.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Australie</li>
<li>Autriche</li>
<li>Canada</li>
<li>Espagne</li>
<li>France</li>
<li>Grèce</li>
<li>Italie</li>
<li>Pays-Bas</li>
<li>Portugal</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region>
<li>Attique (région)</li>
<li>Communauté de Madrid</li>
<li>District de Dresde</li>
<li>Hollande-Méridionale</li>
<li>Latium</li>
<li>Saxe (Land)</li>
<li>Victoria (État)</li>
<li>Île-de-France</li>
</region>
<settlement>
<li>Athènes</li>
<li>Dresde</li>
<li>Melbourne</li>
<li>Paris</li>
<li>Rome</li>
<li>Rotterdam</li>
</settlement>
<orgName>
<li>Université de Melbourne</li>
</orgName>
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<country name="France">
<region name="Île-de-France">
<name sortKey="Roux, C" sort="Roux, C" uniqKey="Roux C" first="C." last="Roux">C. Roux</name>
</region>
</country>
<country name="Allemagne">
<region name="Saxe (Land)">
<name sortKey="Hofbauer, L C" sort="Hofbauer, L C" uniqKey="Hofbauer L" first="L. C." last="Hofbauer">L. C. Hofbauer</name>
</region>
</country>
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<noRegion>
<name sortKey="Ho, P R" sort="Ho, P R" uniqKey="Ho P" first="P. R." last="Ho">P. R. Ho</name>
</noRegion>
<name sortKey="Ferreira, I" sort="Ferreira, I" uniqKey="Ferreira I" first="I." last="Ferreira">I. Ferreira</name>
<name sortKey="Siddhanti, S" sort="Siddhanti, S" uniqKey="Siddhanti S" first="S." last="Siddhanti">S. Siddhanti</name>
<name sortKey="Wagman, R B" sort="Wagman, R B" uniqKey="Wagman R" first="R. B." last="Wagman">R. B. Wagman</name>
</country>
<country name="Australie">
<region name="Victoria (État)">
<name sortKey="Wark, J D" sort="Wark, J D" uniqKey="Wark J" first="J. D." last="Wark">J. D. Wark</name>
</region>
</country>
<country name="Pays-Bas">
<region name="Hollande-Méridionale">
<name sortKey="Zillikens, M C" sort="Zillikens, M C" uniqKey="Zillikens M" first="M. C." last="Zillikens">M. C. Zillikens</name>
</region>
</country>
<country name="Autriche">
<noRegion>
<name sortKey="Fahrleitner Pammer, A" sort="Fahrleitner Pammer, A" uniqKey="Fahrleitner Pammer A" first="A." last="Fahrleitner-Pammer">A. Fahrleitner-Pammer</name>
</noRegion>
</country>
<country name="Espagne">
<region name="Communauté de Madrid">
<name sortKey="Hawkins, F" sort="Hawkins, F" uniqKey="Hawkins F" first="F." last="Hawkins">F. Hawkins</name>
</region>
</country>
<country name="Portugal">
<noRegion>
<name sortKey="Micaelo, M" sort="Micaelo, M" uniqKey="Micaelo M" first="M." last="Micaelo">M. Micaelo</name>
</noRegion>
</country>
<country name="Italie">
<region name="Latium">
<name sortKey="Minisola, S" sort="Minisola, S" uniqKey="Minisola S" first="S." last="Minisola">S. Minisola</name>
</region>
</country>
<country name="Grèce">
<region name="Attique (région)">
<name sortKey="Papaioannou, N" sort="Papaioannou, N" uniqKey="Papaioannou N" first="N." last="Papaioannou">N. Papaioannou</name>
</region>
</country>
<country name="Royaume-Uni">
<noRegion>
<name sortKey="Stone, M" sort="Stone, M" uniqKey="Stone M" first="M." last="Stone">M. Stone</name>
</noRegion>
</country>
<country name="Canada">
<noRegion>
<name sortKey="Brown, J P" sort="Brown, J P" uniqKey="Brown J" first="J. P." last="Brown">J. P. Brown</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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