Bisphosphonates and glucocorticoid osteoporosis in men: results of a randomized controlled trial comparing zoledronic acid with risedronate
Identifieur interne : 005E29 ( Main/Exploration ); précédent : 005E28; suivant : 005E30Bisphosphonates and glucocorticoid osteoporosis in men: results of a randomized controlled trial comparing zoledronic acid with risedronate
Auteurs : Philip N. Sambrook [Australie] ; Christian Roux [France] ; Jean-Pierre Devogelaer [Belgique] ; Kenneth Saag [États-Unis] ; Chak-Sing Lau [Royaume-Uni] ; Jean-Yves Reginster [Belgique] ; Christina Bucci-Rechtweg [États-Unis] ; GUOQIN SU [États-Unis] ; David M. Reid [Royaume-Uni]Source :
- Bone : (New York, NY) [ 8756-3282 ] ; 2012.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
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Abstract
Background: We studied 265 men (mean age 56.4 years; range 18-83 years), among patients enrolled in two arms of a double-blind, 1-year study comparing the effects of zoledronic acid (ZOL) with risedronate (RIS) in patients either commencing (prednisolone 7.5 mg/day or equivalent) (prevention arm, n = 88) or continuing glucocorticoid therapy (treatment arm, n = 177). Methods: Patients received either a single ZOL 5 mg infusion or RIS 5 mg oral daily at randomization, along with calcium (1000 mg) and vitamin D (400-1200 IU). Primary endpoint: difference in percentage change from baseline in bone mineral density (BMD) at the lumbar spine (LS) at 12 months. Secondary endpoints: percentage changes in BMD at total hip (TH) and femoral neck (FN), relative changes in bone turnover markers (β-CTx and P1NP), and overall safety. Findings: In the treatment subpopulation, ZOL increased LS BMD by 4.7% vs. 3.3% for RIS and at TH the percentage changes were 1.8% vs. 0.2%, respectively. In the prevention subpopulation, bone loss was prevented by both treatments. At LS the percentage changes were 2.5% vs. - 0.2% for ZOL vs. RIS and at TH the percentage changes were 1.1% vs. -0.4%, respectively. ZOL significantly increased lumbar spine BMD more than RIS at Month 12 in both the prevention population (p=0.0024) and the treatment subpopulation (p = 0.0232) in men. In the treatment subpopulation, ZOL demonstrated a significantly greater reduction in serum β-CTx and P1NP relative to RIS at all time-points. In the prevention subpopulation, ZOL significantly reduced β-CTx at all time-points, and P1NP at Month 3 (p = 0.0297) only. Both treatments were well tolerated in men, albeit with a higher incidence of influenza-like illness and pyrexia events post-infusion with ZOL. Interpretation: Once-yearly ZOL preserves or increases BMD within 1 year to a greater extent than daily RIS in men receiving glucocorticoid therapy.
Affiliations:
- Australie, Belgique, France, Royaume-Uni, États-Unis
- Nouvelle-Galles du Sud, Province de Liège, Région de Bruxelles-Capitale, Région wallonne, Île-de-France
- Bruxelles, Liège, Paris, Sydney
- Université de Liège, Université de Sydney
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Sambrook</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>University of Sydney</s1><s2>Sydney, NSW</s2><s3>AUS</s3><sZ>1 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation></author><author><name sortKey="Roux, Christian" sort="Roux, Christian" uniqKey="Roux C" first="Christian" last="Roux">Christian Roux</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Paris-Descartes University</s1><s2>Paris</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Devogelaer, Jean Pierre" sort="Devogelaer, Jean Pierre" uniqKey="Devogelaer J" first="Jean-Pierre" last="Devogelaer">Jean-Pierre Devogelaer</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Université Catholique de Louvain at Brussels</s1><s2>Brussels</s2><s3>BEL</s3><sZ>3 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></affiliation></author><author><name sortKey="Saag, Kenneth" sort="Saag, Kenneth" uniqKey="Saag K" first="Kenneth" last="Saag">Kenneth Saag</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>University of Alabama at Birmingham</s1><s2>Birmingham, AL</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>University of Alabama at Birmingham</wicri:noRegion></affiliation></author><author><name sortKey="Lau, Chak Sing" sort="Lau, Chak Sing" uniqKey="Lau C" first="Chak-Sing" last="Lau">Chak-Sing Lau</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>University of Dundee</s1><s2>Dundee</s2><s3>GBR</s3><sZ>5 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>University of Dundee</wicri:noRegion></affiliation></author><author><name sortKey="Reginster, Jean Yves" sort="Reginster, Jean Yves" uniqKey="Reginster J" first="Jean-Yves" last="Reginster">Jean-Yves Reginster</name><affiliation wicri:level="4"><inist:fA14 i1="06"><s1>University of Liège</s1><s2>Liège</s2><s3>BEL</s3><sZ>6 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Liège</settlement><region type="region" nuts="1">Région wallonne</region><region type="province" nuts="1">Province de Liège</region></placeName><orgName type="university">Université de Liège</orgName></affiliation></author><author><name sortKey="Bucci Rechtweg, Christina" sort="Bucci Rechtweg, Christina" uniqKey="Bucci Rechtweg C" first="Christina" last="Bucci-Rechtweg">Christina Bucci-Rechtweg</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Novartis Pharmaceuticals Corporation</s1><s2>East Hanover, NJ</s2><s3>USA</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Novartis Pharmaceuticals Corporation</wicri:noRegion></affiliation></author><author><name sortKey="Guoqin Su" sort="Guoqin Su" uniqKey="Guoqin Su" last="Guoqin Su">GUOQIN SU</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Novartis Pharmaceuticals Corporation</s1><s2>East Hanover, NJ</s2><s3>USA</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Novartis Pharmaceuticals Corporation</wicri:noRegion></affiliation></author><author><name sortKey="Reid, David M" sort="Reid, David M" uniqKey="Reid D" first="David M." last="Reid">David M. Reid</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>University of Aberdeen</s1><s2>Aberdeen</s2><s3>GBR</s3><sZ>9 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>University of Aberdeen</wicri:noRegion></affiliation></author></analytic><series><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="2012">2012</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>Antiosteoclastic agent</term><term>Antiosteoporotic</term><term>Bisphosphonates</term><term>Bone mineral density</term><term>Glucocorticoid</term><term>Human</term><term>Morphology</term><term>Osteoporosis</term><term>Risedronic acid</term><term>Zoledronic acid</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Acide risédronique</term><term>Densité minérale osseuse</term><term>Bisphosphonates</term><term>Glucocorticoïde</term><term>Ostéoporose</term><term>Homme</term><term>Acide zolédronique</term><term>Morphologie</term><term>Antiostéoporotique</term><term>Antiostéoclastique</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background: We studied 265 men (mean age 56.4 years; range 18-83 years), among patients enrolled in two arms of a double-blind, 1-year study comparing the effects of zoledronic acid (ZOL) with risedronate (RIS) in patients either commencing (prednisolone 7.5 mg/day or equivalent) (prevention arm, n = 88) or continuing glucocorticoid therapy (treatment arm, n = 177). Methods: Patients received either a single ZOL 5 mg infusion or RIS 5 mg oral daily at randomization, along with calcium (1000 mg) and vitamin D (400-1200 IU). Primary endpoint: difference in percentage change from baseline in bone mineral density (BMD) at the lumbar spine (LS) at 12 months. Secondary endpoints: percentage changes in BMD at total hip (TH) and femoral neck (FN), relative changes in bone turnover markers (β-CTx and P1NP), and overall safety. Findings: In the treatment subpopulation, ZOL increased LS BMD by 4.7% vs. 3.3% for RIS and at TH the percentage changes were 1.8% vs. 0.2%, respectively. In the prevention subpopulation, bone loss was prevented by both treatments. At LS the percentage changes were 2.5% vs. - 0.2% for ZOL vs. RIS and at TH the percentage changes were 1.1% vs. -0.4%, respectively. ZOL significantly increased lumbar spine BMD more than RIS at Month 12 in both the prevention population (p=0.0024) and the treatment subpopulation (p = 0.0232) in men. In the treatment subpopulation, ZOL demonstrated a significantly greater reduction in serum β-CTx and P1NP relative to RIS at all time-points. In the prevention subpopulation, ZOL significantly reduced β-CTx at all time-points, and P1NP at Month 3 (p = 0.0297) only. Both treatments were well tolerated in men, albeit with a higher incidence of influenza-like illness and pyrexia events post-infusion with ZOL. Interpretation: Once-yearly ZOL preserves or increases BMD within 1 year to a greater extent than daily RIS in men receiving glucocorticoid therapy.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Belgique</li><li>France</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Nouvelle-Galles du Sud</li><li>Province de Liège</li><li>Région de Bruxelles-Capitale</li><li>Région wallonne</li><li>Île-de-France</li></region><settlement><li>Bruxelles</li><li>Liège</li><li>Paris</li><li>Sydney</li></settlement><orgName><li>Université de Liège</li><li>Université de Sydney</li></orgName></list><tree><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Sambrook, Philip N" sort="Sambrook, Philip N" uniqKey="Sambrook P" first="Philip N." last="Sambrook">Philip N. Sambrook</name></region></country><country name="France"><region name="Île-de-France"><name sortKey="Roux, Christian" sort="Roux, Christian" uniqKey="Roux C" first="Christian" last="Roux">Christian Roux</name></region></country><country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Devogelaer, Jean Pierre" sort="Devogelaer, Jean Pierre" uniqKey="Devogelaer J" first="Jean-Pierre" last="Devogelaer">Jean-Pierre Devogelaer</name></region><name sortKey="Reginster, Jean Yves" sort="Reginster, Jean Yves" uniqKey="Reginster J" first="Jean-Yves" last="Reginster">Jean-Yves Reginster</name></country><country name="États-Unis"><noRegion><name sortKey="Saag, Kenneth" sort="Saag, Kenneth" uniqKey="Saag K" first="Kenneth" last="Saag">Kenneth Saag</name></noRegion><name sortKey="Bucci Rechtweg, Christina" sort="Bucci Rechtweg, Christina" uniqKey="Bucci Rechtweg C" first="Christina" last="Bucci-Rechtweg">Christina Bucci-Rechtweg</name><name sortKey="Guoqin Su" sort="Guoqin Su" uniqKey="Guoqin Su" last="Guoqin Su">GUOQIN SU</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Lau, Chak Sing" sort="Lau, Chak Sing" uniqKey="Lau C" first="Chak-Sing" last="Lau">Chak-Sing Lau</name></noRegion><name sortKey="Reid, David M" sort="Reid, David M" uniqKey="Reid D" first="David M." last="Reid">David M. 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