Myostatin antibody (LY2495655) in older weak fallers: a proof-of-concept, randomised, phase 2 trial.
Identifieur interne : 002660 ( PubMed/Corpus ); précédent : 002659; suivant : 002661Myostatin antibody (LY2495655) in older weak fallers: a proof-of-concept, randomised, phase 2 trial.
Auteurs : Clemens Becker ; Stephen R. Lord ; Stephanie A. Studenski ; Stuart J. Warden ; Roger A. Fielding ; Christopher P. Recknor ; Marc C. Hochberg ; Serge L. Ferrari ; Hubert Blain ; Ellen F. Binder ; Yves Rolland ; Serge Poiraudeau ; Charles T. Benson ; Stephen L. Myers ; Leijun Hu ; Qasim I. Ahmad ; Kelli R. Pacuch ; Elisa V. Gomez ; Olivier BenichouSource :
- The lancet. Diabetes & endocrinology [ 2213-8595 ] ; 2015.
English descriptors
- KwdEn :
- Accidental Falls, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized (administration & dosage), Antibodies, Monoclonal, Humanized (adverse effects), Antibodies, Monoclonal, Humanized (therapeutic use), Double-Blind Method, Female, Gait (drug effects), Hand Strength, Humans, Injections, Subcutaneous, Male, Muscle Weakness (drug therapy), Muscle, Skeletal (drug effects), Myostatin (antagonists & inhibitors), Myostatin (immunology), Treatment Outcome.
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Humanized.
- chemical , adverse effects : Antibodies, Monoclonal, Humanized.
- chemical , antagonists & inhibitors : Myostatin.
- chemical , immunology : Myostatin.
- chemical , therapeutic use : Antibodies, Monoclonal, Humanized.
- drug effects : Gait, Muscle, Skeletal.
- drug therapy : Muscle Weakness.
- Accidental Falls, Aged, Aged, 80 and over, Double-Blind Method, Female, Hand Strength, Humans, Injections, Subcutaneous, Male, Treatment Outcome.
Abstract
Myostatin inhibits skeletal muscle growth. The humanised monoclonal antibody LY2495655 (LY) binds and neutralises myostatin. We aimed to test whether LY increases appendicular lean body mass (aLBM) and improves physical performance in older individuals who have had recent falls and low muscle strength and power.
DOI: 10.1016/S2213-8587(15)00298-3
PubMed: 26516121
Links to Exploration step
pubmed:26516121Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Myostatin antibody (LY2495655) in older weak fallers: a proof-of-concept, randomised, phase 2 trial.</title><author><name sortKey="Becker, Clemens" sort="Becker, Clemens" uniqKey="Becker C" first="Clemens" last="Becker">Clemens Becker</name><affiliation><nlm:affiliation>Robert-Bosch-Krankenhaus, Stuttgart, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Lord, Stephen R" sort="Lord, Stephen R" uniqKey="Lord S" first="Stephen R" last="Lord">Stephen R. Lord</name><affiliation><nlm:affiliation>NeuRA, UNSW, Sydney, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Studenski, Stephanie A" sort="Studenski, Stephanie A" uniqKey="Studenski S" first="Stephanie A" last="Studenski">Stephanie A. Studenski</name><affiliation><nlm:affiliation>University of Pittsburgh, Pittsburgh, PA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Warden, Stuart J" sort="Warden, Stuart J" uniqKey="Warden S" first="Stuart J" last="Warden">Stuart J. Warden</name><affiliation><nlm:affiliation>School of Health and Rehabilitation Sciences, Indiana University, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Fielding, Roger A" sort="Fielding, Roger A" uniqKey="Fielding R" first="Roger A" last="Fielding">Roger A. Fielding</name><affiliation><nlm:affiliation>Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Recknor, Christopher P" sort="Recknor, Christopher P" uniqKey="Recknor C" first="Christopher P" last="Recknor">Christopher P. Recknor</name><affiliation><nlm:affiliation>United Osteoporosis Centers, Gainesville, GA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hochberg, Marc C" sort="Hochberg, Marc C" uniqKey="Hochberg M" first="Marc C" last="Hochberg">Marc C. Hochberg</name><affiliation><nlm:affiliation>University of Maryland School of Medicine, Baltimore, MD, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Ferrari, Serge L" sort="Ferrari, Serge L" uniqKey="Ferrari S" first="Serge L" last="Ferrari">Serge L. Ferrari</name><affiliation><nlm:affiliation>Geneva University Hospital, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Blain, Hubert" sort="Blain, Hubert" uniqKey="Blain H" first="Hubert" last="Blain">Hubert Blain</name><affiliation><nlm:affiliation>Department of Internal Medicine and Geriatrics, Montpellier University Hospital, M2H, MACVIA-LR, Montpellier University, Montpellier, France.</nlm:affiliation></affiliation></author><author><name sortKey="Binder, Ellen F" sort="Binder, Ellen F" uniqKey="Binder E" first="Ellen F" last="Binder">Ellen F. Binder</name><affiliation><nlm:affiliation>Washington University School of Medicine, St Louis, MO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Rolland, Yves" sort="Rolland, Yves" uniqKey="Rolland Y" first="Yves" last="Rolland">Yves Rolland</name><affiliation><nlm:affiliation>Gérontopôle de Toulouse, Centre Hospitalo‑Universitaire de Toulouse, and INSERM 1027, Toulouse, France.</nlm:affiliation></affiliation></author><author><name sortKey="Poiraudeau, Serge" sort="Poiraudeau, Serge" uniqKey="Poiraudeau S" first="Serge" last="Poiraudeau">Serge Poiraudeau</name><affiliation><nlm:affiliation>Department of Physical Rehabilitation for Musculoskeletal and Spinal Disorders, Cochin Hospital, Paris, France; Paris Descartes University, Paris, France; INSERM U1153, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Benson, Charles T" sort="Benson, Charles T" uniqKey="Benson C" first="Charles T" last="Benson">Charles T. Benson</name><affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Myers, Stephen L" sort="Myers, Stephen L" uniqKey="Myers S" first="Stephen L" last="Myers">Stephen L. Myers</name><affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hu, Leijun" sort="Hu, Leijun" uniqKey="Hu L" first="Leijun" last="Hu">Leijun Hu</name><affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Ahmad, Qasim I" sort="Ahmad, Qasim I" uniqKey="Ahmad Q" first="Qasim I" last="Ahmad">Qasim I. Ahmad</name><affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Pacuch, Kelli R" sort="Pacuch, Kelli R" uniqKey="Pacuch K" first="Kelli R" last="Pacuch">Kelli R. Pacuch</name><affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Gomez, Elisa V" sort="Gomez, Elisa V" uniqKey="Gomez E" first="Elisa V" last="Gomez">Elisa V. Gomez</name><affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Benichou, Olivier" sort="Benichou, Olivier" uniqKey="Benichou O" first="Olivier" last="Benichou">Olivier Benichou</name><affiliation><nlm:affiliation>Eli Lilly and Company, Neuilly, France. Electronic address: benichou_olivier@lilly.com.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:26516121</idno><idno type="pmid">26516121</idno><idno type="doi">10.1016/S2213-8587(15)00298-3</idno><idno type="wicri:Area/PubMed/Corpus">002660</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002660</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Myostatin antibody (LY2495655) in older weak fallers: a proof-of-concept, randomised, phase 2 trial.</title><author><name sortKey="Becker, Clemens" sort="Becker, Clemens" uniqKey="Becker C" first="Clemens" last="Becker">Clemens Becker</name><affiliation><nlm:affiliation>Robert-Bosch-Krankenhaus, Stuttgart, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Lord, Stephen R" sort="Lord, Stephen R" uniqKey="Lord S" first="Stephen R" last="Lord">Stephen R. Lord</name><affiliation><nlm:affiliation>NeuRA, UNSW, Sydney, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Studenski, Stephanie A" sort="Studenski, Stephanie A" uniqKey="Studenski S" first="Stephanie A" last="Studenski">Stephanie A. Studenski</name><affiliation><nlm:affiliation>University of Pittsburgh, Pittsburgh, PA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Warden, Stuart J" sort="Warden, Stuart J" uniqKey="Warden S" first="Stuart J" last="Warden">Stuart J. Warden</name><affiliation><nlm:affiliation>School of Health and Rehabilitation Sciences, Indiana University, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Fielding, Roger A" sort="Fielding, Roger A" uniqKey="Fielding R" first="Roger A" last="Fielding">Roger A. Fielding</name><affiliation><nlm:affiliation>Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Recknor, Christopher P" sort="Recknor, Christopher P" uniqKey="Recknor C" first="Christopher P" last="Recknor">Christopher P. Recknor</name><affiliation><nlm:affiliation>United Osteoporosis Centers, Gainesville, GA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hochberg, Marc C" sort="Hochberg, Marc C" uniqKey="Hochberg M" first="Marc C" last="Hochberg">Marc C. Hochberg</name><affiliation><nlm:affiliation>University of Maryland School of Medicine, Baltimore, MD, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Ferrari, Serge L" sort="Ferrari, Serge L" uniqKey="Ferrari S" first="Serge L" last="Ferrari">Serge L. Ferrari</name><affiliation><nlm:affiliation>Geneva University Hospital, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Blain, Hubert" sort="Blain, Hubert" uniqKey="Blain H" first="Hubert" last="Blain">Hubert Blain</name><affiliation><nlm:affiliation>Department of Internal Medicine and Geriatrics, Montpellier University Hospital, M2H, MACVIA-LR, Montpellier University, Montpellier, France.</nlm:affiliation></affiliation></author><author><name sortKey="Binder, Ellen F" sort="Binder, Ellen F" uniqKey="Binder E" first="Ellen F" last="Binder">Ellen F. Binder</name><affiliation><nlm:affiliation>Washington University School of Medicine, St Louis, MO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Rolland, Yves" sort="Rolland, Yves" uniqKey="Rolland Y" first="Yves" last="Rolland">Yves Rolland</name><affiliation><nlm:affiliation>Gérontopôle de Toulouse, Centre Hospitalo‑Universitaire de Toulouse, and INSERM 1027, Toulouse, France.</nlm:affiliation></affiliation></author><author><name sortKey="Poiraudeau, Serge" sort="Poiraudeau, Serge" uniqKey="Poiraudeau S" first="Serge" last="Poiraudeau">Serge Poiraudeau</name><affiliation><nlm:affiliation>Department of Physical Rehabilitation for Musculoskeletal and Spinal Disorders, Cochin Hospital, Paris, France; Paris Descartes University, Paris, France; INSERM U1153, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Benson, Charles T" sort="Benson, Charles T" uniqKey="Benson C" first="Charles T" last="Benson">Charles T. Benson</name><affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Myers, Stephen L" sort="Myers, Stephen L" uniqKey="Myers S" first="Stephen L" last="Myers">Stephen L. Myers</name><affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hu, Leijun" sort="Hu, Leijun" uniqKey="Hu L" first="Leijun" last="Hu">Leijun Hu</name><affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Ahmad, Qasim I" sort="Ahmad, Qasim I" uniqKey="Ahmad Q" first="Qasim I" last="Ahmad">Qasim I. Ahmad</name><affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Pacuch, Kelli R" sort="Pacuch, Kelli R" uniqKey="Pacuch K" first="Kelli R" last="Pacuch">Kelli R. Pacuch</name><affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Gomez, Elisa V" sort="Gomez, Elisa V" uniqKey="Gomez E" first="Elisa V" last="Gomez">Elisa V. Gomez</name><affiliation><nlm:affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Benichou, Olivier" sort="Benichou, Olivier" uniqKey="Benichou O" first="Olivier" last="Benichou">Olivier Benichou</name><affiliation><nlm:affiliation>Eli Lilly and Company, Neuilly, France. Electronic address: benichou_olivier@lilly.com.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The lancet. Diabetes & endocrinology</title><idno type="eISSN">2213-8595</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Accidental Falls</term><term>Aged</term><term>Aged, 80 and over</term><term>Antibodies, Monoclonal, Humanized (administration & dosage)</term><term>Antibodies, Monoclonal, Humanized (adverse effects)</term><term>Antibodies, Monoclonal, Humanized (therapeutic use)</term><term>Double-Blind Method</term><term>Female</term><term>Gait (drug effects)</term><term>Hand Strength</term><term>Humans</term><term>Injections, Subcutaneous</term><term>Male</term><term>Muscle Weakness (drug therapy)</term><term>Muscle, Skeletal (drug effects)</term><term>Myostatin (antagonists & inhibitors)</term><term>Myostatin (immunology)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Myostatin</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Myostatin</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Gait</term><term>Muscle, Skeletal</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Muscle Weakness</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Accidental Falls</term><term>Aged</term><term>Aged, 80 and over</term><term>Double-Blind Method</term><term>Female</term><term>Hand Strength</term><term>Humans</term><term>Injections, Subcutaneous</term><term>Male</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Myostatin inhibits skeletal muscle growth. The humanised monoclonal antibody LY2495655 (LY) binds and neutralises myostatin. We aimed to test whether LY increases appendicular lean body mass (aLBM) and improves physical performance in older individuals who have had recent falls and low muscle strength and power.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26516121</PMID><DateCreated><Year>2015</Year><Month>11</Month><Day>23</Day></DateCreated><DateCompleted><Year>2016</Year><Month>09</Month><Day>01</Day></DateCompleted><DateRevised><Year>2015</Year><Month>11</Month><Day>23</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2213-8595</ISSN><JournalIssue CitedMedium="Internet"><Volume>3</Volume><Issue>12</Issue><PubDate><Year>2015</Year><Month>Dec</Month></PubDate></JournalIssue><Title>The lancet. Diabetes & endocrinology</Title><ISOAbbreviation>Lancet Diabetes Endocrinol</ISOAbbreviation></Journal><ArticleTitle>Myostatin antibody (LY2495655) in older weak fallers: a proof-of-concept, randomised, phase 2 trial.</ArticleTitle><Pagination><MedlinePgn>948-57</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/S2213-8587(15)00298-3</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S2213-8587(15)00298-3</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Myostatin inhibits skeletal muscle growth. The humanised monoclonal antibody LY2495655 (LY) binds and neutralises myostatin. We aimed to test whether LY increases appendicular lean body mass (aLBM) and improves physical performance in older individuals who have had recent falls and low muscle strength and power.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">In this proof-of-concept, randomised, placebo-controlled, double-blind, parallel, multicentre, phase 2 study, we recruited patients aged 75 years or older who had fallen in the past year from 21 investigator sites across Argentina, Australia, France, Germany, Sweden, and the USA. Eligible patients had low performance on hand grip strength and chair rise tests, tested with the procedure described by Guralnik and colleagues. Participants were stratified by country, age, hand grip strength, and performance on the chair rise test, and were randomly assigned (1:1) by a computer-generated random sequence to receive subcutaneous injections of placebo or 315 mg LY at weeks 0 (randomisation visit), 4, 8, 12, 16, and 20, followed by 16 weeks observation. The primary outcome was change in aLBM from baseline to 24 weeks. We measured physical performance as secondary outcomes (four-step stair climbing time, usual gait speed, and time to rise five times from a chair without arms, or with arms for participants unable to do it without arms) and exploratory outcomes (12-step stair climbing test, 6-min walking distance, fast gait speed, hand grip strength, and isometric leg extension strength). Efficacy analyses included all randomly assigned patients who received at least one dose and had a baseline and at least one subsequent measure. The primary analysis and all other tests of treatment effect (except physical performance tests) were done at a two-sided alpha level of 0·05. Tests of treatment effect on physical performance tests were done at a pre-specified two-sided alpha level of 0·1. This trial is registered with ClinicalTrials.gov, number NCT01604408.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between June 19, 2012, and Dec 12, 2013, we screened 365 patients. 99 were randomly assigned to receive placebo and 102 to receive LY. Treatment was completed in 85 (86%) of patients given placebo and in 82 (80%) given LY. At 24 weeks, the least-squares mean change in aLBM was -0·123 kg (95% CI -0·287 to 0·040) in the placebo group and 0·303 kg (0·135 to 0·470) in the LY group, a difference of 0·43 kg (95% CI 0·192 to 0·660; p<0·0001). Stair climbing time (four-step and 12-step tests), chair rise with arms, and fast gait speed improved significantly from baseline to week 24 with differences between LY and placebo of respectively -0·46 s (p=0·093), -1·28 s (p=0·011), -4·15 s (p=0·054), and 0·05 m/s (p=0·088). No effect was detected for other performance-based measures. Injection site reactions were recorded in nine (9%) patients given placebo and in 31 (30%) patients given LY (p<0·0001), and were generally mild, and led to treatment discontinuation in two patients given LY.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Our findings show LY treatment increases lean mass and might improve functional measures of muscle power. Although additional studies are needed to confirm these results, our data suggest LY should be tested for its potential ability to reduce the risk of falls or physical dependency in older weak fallers.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Eli Lilly and Company.</AbstractText><CopyrightInformation>Copyright © 2015 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Becker</LastName><ForeName>Clemens</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Robert-Bosch-Krankenhaus, Stuttgart, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lord</LastName><ForeName>Stephen R</ForeName><Initials>SR</Initials><AffiliationInfo><Affiliation>NeuRA, UNSW, Sydney, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Studenski</LastName><ForeName>Stephanie A</ForeName><Initials>SA</Initials><AffiliationInfo><Affiliation>University of Pittsburgh, Pittsburgh, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Warden</LastName><ForeName>Stuart J</ForeName><Initials>SJ</Initials><AffiliationInfo><Affiliation>School of Health and Rehabilitation Sciences, Indiana University, Indianapolis, IN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fielding</LastName><ForeName>Roger A</ForeName><Initials>RA</Initials><AffiliationInfo><Affiliation>Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Recknor</LastName><ForeName>Christopher P</ForeName><Initials>CP</Initials><AffiliationInfo><Affiliation>United Osteoporosis Centers, Gainesville, GA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hochberg</LastName><ForeName>Marc C</ForeName><Initials>MC</Initials><AffiliationInfo><Affiliation>University of Maryland School of Medicine, Baltimore, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ferrari</LastName><ForeName>Serge L</ForeName><Initials>SL</Initials><AffiliationInfo><Affiliation>Geneva University Hospital, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Blain</LastName><ForeName>Hubert</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine and Geriatrics, Montpellier University Hospital, M2H, MACVIA-LR, Montpellier University, Montpellier, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Binder</LastName><ForeName>Ellen F</ForeName><Initials>EF</Initials><AffiliationInfo><Affiliation>Washington University School of Medicine, St Louis, MO, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rolland</LastName><ForeName>Yves</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Gérontopôle de Toulouse, Centre Hospitalo‑Universitaire de Toulouse, and INSERM 1027, Toulouse, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Poiraudeau</LastName><ForeName>Serge</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Physical Rehabilitation for Musculoskeletal and Spinal Disorders, Cochin Hospital, Paris, France; Paris Descartes University, Paris, France; INSERM U1153, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Benson</LastName><ForeName>Charles T</ForeName><Initials>CT</Initials><AffiliationInfo><Affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Myers</LastName><ForeName>Stephen L</ForeName><Initials>SL</Initials><AffiliationInfo><Affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hu</LastName><ForeName>Leijun</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ahmad</LastName><ForeName>Qasim I</ForeName><Initials>QI</Initials><AffiliationInfo><Affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pacuch</LastName><ForeName>Kelli R</ForeName><Initials>KR</Initials><AffiliationInfo><Affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gomez</LastName><ForeName>Elisa V</ForeName><Initials>EV</Initials><AffiliationInfo><Affiliation>Eli Lilly and Company, Indianapolis, IN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Benichou</LastName><ForeName>Olivier</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>Eli Lilly and Company, Neuilly, France. Electronic address: benichou_olivier@lilly.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>STEADY Group</CollectiveName></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01604408</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>10</Month><Day>27</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet Diabetes 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