Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: Efficacy and safety results from a randomized open-label study
Identifieur interne : 004285 ( Main/Merge ); précédent : 004284; suivant : 004286Denosumab 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 :
- Bone : (New York, NY) [ 8756-3282 ] ; 2014.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Femme.
English descriptors
- KwdEn :
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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Pascal:14-0062999Le document en format XML
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<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Laval University, CHU de Québec (CHUL), Room S-763, 2705 Laurier boulevard</s1>
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<sourceDesc><biblStruct><analytic><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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<author><name sortKey="Stone, M" sort="Stone, M" uniqKey="Stone M" first="M." last="Stone">M. Stone</name>
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<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Amgen Inc.</s1>
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<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>
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<sZ>15 aut.</sZ>
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<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>
</list>
<tree><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>
<country name="États-Unis"><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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