Adherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronate
Summary In this study, 250 women with osteoporosis were randomized to 12 months with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly, then crossed over to the other treatment. The primary endpoint, treatment adherence at 12 months, was 76.6% for alendronate and 87.3...
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| Veröffentlicht in: | Osteoporosis international 2011-06, Vol.22 (6), p.1725-1735 |
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| creator | Kendler, D. L. McClung, M. R. Freemantle, N. Lillestol, M. Moffett, A. H. Borenstein, J. Satram-Hoang, S. Yang, Y.-C. Kaur, P. Macarios, D. Siddhanti, S. |
| description | Summary
In this study, 250 women with osteoporosis were randomized to 12 months with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly, then crossed over to the other treatment. The primary endpoint, treatment adherence at 12 months, was 76.6% for alendronate and 87.3% for denosumab.
Introduction
The purpose of this study is to evaluate treatment adherence with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly.
Methods
In this multicenter, randomized, open-label, 2-year, crossover study, 250 postmenopausal women with low bone mineral density received denosumab or alendronate for 12 months, then the other treatment for 12 months. The alendronate bottle had a medication event monitoring system cap to monitor administration dates. Definitions were as follows: compliance, receiving both denosumab doses 6 (±1) months apart or 80–100% of alendronate doses; persistence, receiving both denosumab doses and completing the month 12 visit within the visit window or ≥2 alendronate doses in the final month; adherence, achieving both compliance and persistence. This report includes data from the first 12 months.
Results
The primary study endpoint, adherence in the first 12 months, was 76.6% (95/124) for alendronate and 87.3% (110/126) for denosumab. Risk ratios for denosumab compared with alendronate at 12 months were 0.58 (
p
= 0.043) for non-adherence, 0.48 (
p
= 0.014) for non-compliance, and 0.54 (
p
= 0.049) for non-persistence. Subject ratings for treatment necessity, preference, and satisfaction were significantly greater for denosumab and ratings for treatment bother were significantly greater for alendronate. Adverse events were reported by 64.1% of alendronate-treated subjects and 72.0% of denosumab-treated subjects (
p
= 0.403). The most common adverse events were arthralgia, back pain, pain in extremity, cough, and headache (each in |
| doi_str_mv | 10.1007/s00198-010-1378-z |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_876225731</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2393956161</sourcerecordid><originalsourceid>FETCH-LOGICAL-c432t-5afc3333575d589034d5ccb754d4aa3c222873c776b5d86d90491c9d465b56683</originalsourceid><addsrcrecordid>eNp1kE9rFTEUxYNU7Gv1A7gpoSDdOJq_k2RZim2FghsFd-FOkqlTZ5JpMkNpP715vFcLgtkk9-Z37j0chN5T8okSoj4XQqjRDaGkoVzp5ukV2lDBecNMKw_QhhiuGiPoz0N0VModqRpj1Bt0yIhmSgq1Qfbc_wo5RBc-4jmH_vkN0eMCy1B6cMuQIk49nlNZphDTDGuBET-kWuAFfg_xFvvaL-sEHU4ZwxiizynCEt6i1z2MJbzb38fox-WX7xfXzc23q68X5zeNE5wtjYTe8Xqkkl5qQ7jw0rmuevQCgDvGmFbcKdV20uvWGyIMdcaLVnaybTU_Rme7uXNO92soi52G4sI4QgxpLVarljGpOK3k6T_kXVpzrOYqJCU3XGwhuoNcTqXUXOychwnyo6XEbrO3u-wt2dY1e_tUNSf7wWs3Bf9X8Rx2BT7sASgOxj5DdEN54QTVkklRObbjSv2KtyG_OPz_9j_VjJw3</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>875539341</pqid></control><display><type>article</type><title>Adherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronate</title><source>MEDLINE</source><source>SpringerLink Journals</source><creator>Kendler, D. L. ; McClung, M. R. ; Freemantle, N. ; Lillestol, M. ; Moffett, A. H. ; Borenstein, J. ; Satram-Hoang, S. ; Yang, Y.-C. ; Kaur, P. ; Macarios, D. ; Siddhanti, S.</creator><creatorcontrib>Kendler, D. L. ; McClung, M. R. ; Freemantle, N. ; Lillestol, M. ; Moffett, A. H. ; Borenstein, J. ; Satram-Hoang, S. ; Yang, Y.-C. ; Kaur, P. ; Macarios, D. ; Siddhanti, S. ; DAPS Investigators ; on behalf of the DAPS Investigators</creatorcontrib><description>Summary
In this study, 250 women with osteoporosis were randomized to 12 months with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly, then crossed over to the other treatment. The primary endpoint, treatment adherence at 12 months, was 76.6% for alendronate and 87.3% for denosumab.
Introduction
The purpose of this study is to evaluate treatment adherence with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly.
Methods
In this multicenter, randomized, open-label, 2-year, crossover study, 250 postmenopausal women with low bone mineral density received denosumab or alendronate for 12 months, then the other treatment for 12 months. The alendronate bottle had a medication event monitoring system cap to monitor administration dates. Definitions were as follows: compliance, receiving both denosumab doses 6 (±1) months apart or 80–100% of alendronate doses; persistence, receiving both denosumab doses and completing the month 12 visit within the visit window or ≥2 alendronate doses in the final month; adherence, achieving both compliance and persistence. This report includes data from the first 12 months.
Results
The primary study endpoint, adherence in the first 12 months, was 76.6% (95/124) for alendronate and 87.3% (110/126) for denosumab. Risk ratios for denosumab compared with alendronate at 12 months were 0.58 (
p
= 0.043) for non-adherence, 0.48 (
p
= 0.014) for non-compliance, and 0.54 (
p
= 0.049) for non-persistence. Subject ratings for treatment necessity, preference, and satisfaction were significantly greater for denosumab and ratings for treatment bother were significantly greater for alendronate. Adverse events were reported by 64.1% of alendronate-treated subjects and 72.0% of denosumab-treated subjects (
p
= 0.403). The most common adverse events were arthralgia, back pain, pain in extremity, cough, and headache (each in <10% of subjects in each group).
Conclusions
Significantly greater treatment adherence was observed for subcutaneous administration of denosumab every 6 months than for oral alendronate once weekly.</description><identifier>ISSN: 0937-941X</identifier><identifier>EISSN: 1433-2965</identifier><identifier>DOI: 10.1007/s00198-010-1378-z</identifier><identifier>PMID: 20827547</identifier><language>eng</language><publisher>London: Springer-Verlag</publisher><subject><![CDATA[Administration, Oral ; Aged ; Alendronate - administration & dosage ; Alendronate - adverse effects ; Alendronate - therapeutic use ; Antibodies, Monoclonal - administration & dosage ; Antibodies, Monoclonal - adverse effects ; Antibodies, Monoclonal - therapeutic use ; Antibodies, Monoclonal, Humanized ; Biological and medical sciences ; Bone Density - drug effects ; Bone Density Conservation Agents - administration & dosage ; Bone Density Conservation Agents - adverse effects ; Bone Density Conservation Agents - therapeutic use ; Bones, joints and connective tissue. Antiinflammatory agents ; British Columbia ; Compliance ; Denosumab ; Diseases of the osteoarticular system ; Drug therapy ; Endocrinology ; Epidemiologic Methods ; Female ; Humans ; Immunomodulators ; Injections, Subcutaneous ; Medical sciences ; Medication Adherence - statistics & numerical data ; Medicine ; Medicine & Public Health ; Middle Aged ; Original Article ; Orthopedics ; Osteoporosis ; Osteoporosis, Postmenopausal - drug therapy ; Osteoporosis, Postmenopausal - physiopathology ; Osteoporosis, Postmenopausal - psychology ; Osteoporosis. Osteomalacia. Paget disease ; Patient Preference - statistics & numerical data ; Patient Satisfaction - statistics & numerical data ; Pharmacology. Drug treatments ; Preferences ; Rheumatology ; Side effects ; Treatment Outcome ; Women]]></subject><ispartof>Osteoporosis international, 2011-06, Vol.22 (6), p.1725-1735</ispartof><rights>International Osteoporosis Foundation and National Osteoporosis Foundation 2010</rights><rights>2015 INIST-CNRS</rights><rights>International Osteoporosis Foundation and National Osteoporosis Foundation 2011</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c432t-5afc3333575d589034d5ccb754d4aa3c222873c776b5d86d90491c9d465b56683</citedby><cites>FETCH-LOGICAL-c432t-5afc3333575d589034d5ccb754d4aa3c222873c776b5d86d90491c9d465b56683</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00198-010-1378-z$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00198-010-1378-z$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24185254$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20827547$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kendler, D. L.</creatorcontrib><creatorcontrib>McClung, M. R.</creatorcontrib><creatorcontrib>Freemantle, N.</creatorcontrib><creatorcontrib>Lillestol, M.</creatorcontrib><creatorcontrib>Moffett, A. H.</creatorcontrib><creatorcontrib>Borenstein, J.</creatorcontrib><creatorcontrib>Satram-Hoang, S.</creatorcontrib><creatorcontrib>Yang, Y.-C.</creatorcontrib><creatorcontrib>Kaur, P.</creatorcontrib><creatorcontrib>Macarios, D.</creatorcontrib><creatorcontrib>Siddhanti, S.</creatorcontrib><creatorcontrib>DAPS Investigators</creatorcontrib><creatorcontrib>on behalf of the DAPS Investigators</creatorcontrib><title>Adherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronate</title><title>Osteoporosis international</title><addtitle>Osteoporos Int</addtitle><addtitle>Osteoporos Int</addtitle><description>Summary
In this study, 250 women with osteoporosis were randomized to 12 months with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly, then crossed over to the other treatment. The primary endpoint, treatment adherence at 12 months, was 76.6% for alendronate and 87.3% for denosumab.
Introduction
The purpose of this study is to evaluate treatment adherence with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly.
Methods
In this multicenter, randomized, open-label, 2-year, crossover study, 250 postmenopausal women with low bone mineral density received denosumab or alendronate for 12 months, then the other treatment for 12 months. The alendronate bottle had a medication event monitoring system cap to monitor administration dates. Definitions were as follows: compliance, receiving both denosumab doses 6 (±1) months apart or 80–100% of alendronate doses; persistence, receiving both denosumab doses and completing the month 12 visit within the visit window or ≥2 alendronate doses in the final month; adherence, achieving both compliance and persistence. This report includes data from the first 12 months.
Results
The primary study endpoint, adherence in the first 12 months, was 76.6% (95/124) for alendronate and 87.3% (110/126) for denosumab. Risk ratios for denosumab compared with alendronate at 12 months were 0.58 (
p
= 0.043) for non-adherence, 0.48 (
p
= 0.014) for non-compliance, and 0.54 (
p
= 0.049) for non-persistence. Subject ratings for treatment necessity, preference, and satisfaction were significantly greater for denosumab and ratings for treatment bother were significantly greater for alendronate. Adverse events were reported by 64.1% of alendronate-treated subjects and 72.0% of denosumab-treated subjects (
p
= 0.403). The most common adverse events were arthralgia, back pain, pain in extremity, cough, and headache (each in <10% of subjects in each group).
Conclusions
Significantly greater treatment adherence was observed for subcutaneous administration of denosumab every 6 months than for oral alendronate once weekly.</description><subject>Administration, Oral</subject><subject>Aged</subject><subject>Alendronate - administration & dosage</subject><subject>Alendronate - adverse effects</subject><subject>Alendronate - therapeutic use</subject><subject>Antibodies, Monoclonal - administration & dosage</subject><subject>Antibodies, Monoclonal - adverse effects</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antibodies, Monoclonal, Humanized</subject><subject>Biological and medical sciences</subject><subject>Bone Density - drug effects</subject><subject>Bone Density Conservation Agents - administration & dosage</subject><subject>Bone Density Conservation Agents - adverse effects</subject><subject>Bone Density Conservation Agents - therapeutic use</subject><subject>Bones, joints and connective tissue. Antiinflammatory agents</subject><subject>British Columbia</subject><subject>Compliance</subject><subject>Denosumab</subject><subject>Diseases of the osteoarticular system</subject><subject>Drug therapy</subject><subject>Endocrinology</subject><subject>Epidemiologic Methods</subject><subject>Female</subject><subject>Humans</subject><subject>Immunomodulators</subject><subject>Injections, Subcutaneous</subject><subject>Medical sciences</subject><subject>Medication Adherence - statistics & numerical data</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Original Article</subject><subject>Orthopedics</subject><subject>Osteoporosis</subject><subject>Osteoporosis, Postmenopausal - drug therapy</subject><subject>Osteoporosis, Postmenopausal - physiopathology</subject><subject>Osteoporosis, Postmenopausal - psychology</subject><subject>Osteoporosis. Osteomalacia. Paget disease</subject><subject>Patient Preference - statistics & numerical data</subject><subject>Patient Satisfaction - statistics & numerical data</subject><subject>Pharmacology. Drug treatments</subject><subject>Preferences</subject><subject>Rheumatology</subject><subject>Side effects</subject><subject>Treatment Outcome</subject><subject>Women</subject><issn>0937-941X</issn><issn>1433-2965</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kE9rFTEUxYNU7Gv1A7gpoSDdOJq_k2RZim2FghsFd-FOkqlTZ5JpMkNpP715vFcLgtkk9-Z37j0chN5T8okSoj4XQqjRDaGkoVzp5ukV2lDBecNMKw_QhhiuGiPoz0N0VModqRpj1Bt0yIhmSgq1Qfbc_wo5RBc-4jmH_vkN0eMCy1B6cMuQIk49nlNZphDTDGuBET-kWuAFfg_xFvvaL-sEHU4ZwxiizynCEt6i1z2MJbzb38fox-WX7xfXzc23q68X5zeNE5wtjYTe8Xqkkl5qQ7jw0rmuevQCgDvGmFbcKdV20uvWGyIMdcaLVnaybTU_Rme7uXNO92soi52G4sI4QgxpLVarljGpOK3k6T_kXVpzrOYqJCU3XGwhuoNcTqXUXOychwnyo6XEbrO3u-wt2dY1e_tUNSf7wWs3Bf9X8Rx2BT7sASgOxj5DdEN54QTVkklRObbjSv2KtyG_OPz_9j_VjJw3</recordid><startdate>20110601</startdate><enddate>20110601</enddate><creator>Kendler, D. L.</creator><creator>McClung, M. R.</creator><creator>Freemantle, N.</creator><creator>Lillestol, M.</creator><creator>Moffett, A. H.</creator><creator>Borenstein, J.</creator><creator>Satram-Hoang, S.</creator><creator>Yang, Y.-C.</creator><creator>Kaur, P.</creator><creator>Macarios, D.</creator><creator>Siddhanti, S.</creator><general>Springer-Verlag</general><general>Springer</general><general>Springer Nature B.V</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QP</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20110601</creationdate><title>Adherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronate</title><author>Kendler, D. L. ; McClung, M. R. ; Freemantle, N. ; Lillestol, M. ; Moffett, A. H. ; Borenstein, J. ; Satram-Hoang, S. ; Yang, Y.-C. ; Kaur, P. ; Macarios, D. ; Siddhanti, S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c432t-5afc3333575d589034d5ccb754d4aa3c222873c776b5d86d90491c9d465b56683</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Administration, Oral</topic><topic>Aged</topic><topic>Alendronate - administration & dosage</topic><topic>Alendronate - adverse effects</topic><topic>Alendronate - therapeutic use</topic><topic>Antibodies, Monoclonal - administration & dosage</topic><topic>Antibodies, Monoclonal - adverse effects</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Antibodies, Monoclonal, Humanized</topic><topic>Biological and medical sciences</topic><topic>Bone Density - drug effects</topic><topic>Bone Density Conservation Agents - administration & dosage</topic><topic>Bone Density Conservation Agents - adverse effects</topic><topic>Bone Density Conservation Agents - therapeutic use</topic><topic>Bones, joints and connective tissue. Antiinflammatory agents</topic><topic>British Columbia</topic><topic>Compliance</topic><topic>Denosumab</topic><topic>Diseases of the osteoarticular system</topic><topic>Drug therapy</topic><topic>Endocrinology</topic><topic>Epidemiologic Methods</topic><topic>Female</topic><topic>Humans</topic><topic>Immunomodulators</topic><topic>Injections, Subcutaneous</topic><topic>Medical sciences</topic><topic>Medication Adherence - statistics & numerical data</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Original Article</topic><topic>Orthopedics</topic><topic>Osteoporosis</topic><topic>Osteoporosis, Postmenopausal - drug therapy</topic><topic>Osteoporosis, Postmenopausal - physiopathology</topic><topic>Osteoporosis, Postmenopausal - psychology</topic><topic>Osteoporosis. Osteomalacia. Paget disease</topic><topic>Patient Preference - statistics & numerical data</topic><topic>Patient Satisfaction - statistics & numerical data</topic><topic>Pharmacology. Drug treatments</topic><topic>Preferences</topic><topic>Rheumatology</topic><topic>Side effects</topic><topic>Treatment Outcome</topic><topic>Women</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kendler, D. L.</creatorcontrib><creatorcontrib>McClung, M. R.</creatorcontrib><creatorcontrib>Freemantle, N.</creatorcontrib><creatorcontrib>Lillestol, M.</creatorcontrib><creatorcontrib>Moffett, A. H.</creatorcontrib><creatorcontrib>Borenstein, J.</creatorcontrib><creatorcontrib>Satram-Hoang, S.</creatorcontrib><creatorcontrib>Yang, Y.-C.</creatorcontrib><creatorcontrib>Kaur, P.</creatorcontrib><creatorcontrib>Macarios, D.</creatorcontrib><creatorcontrib>Siddhanti, S.</creatorcontrib><creatorcontrib>DAPS Investigators</creatorcontrib><creatorcontrib>on behalf of the DAPS Investigators</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><jtitle>Osteoporosis international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kendler, D. L.</au><au>McClung, M. R.</au><au>Freemantle, N.</au><au>Lillestol, M.</au><au>Moffett, A. H.</au><au>Borenstein, J.</au><au>Satram-Hoang, S.</au><au>Yang, Y.-C.</au><au>Kaur, P.</au><au>Macarios, D.</au><au>Siddhanti, S.</au><aucorp>DAPS Investigators</aucorp><aucorp>on behalf of the DAPS Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Adherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronate</atitle><jtitle>Osteoporosis international</jtitle><stitle>Osteoporos Int</stitle><addtitle>Osteoporos Int</addtitle><date>2011-06-01</date><risdate>2011</risdate><volume>22</volume><issue>6</issue><spage>1725</spage><epage>1735</epage><pages>1725-1735</pages><issn>0937-941X</issn><eissn>1433-2965</eissn><abstract>Summary
In this study, 250 women with osteoporosis were randomized to 12 months with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly, then crossed over to the other treatment. The primary endpoint, treatment adherence at 12 months, was 76.6% for alendronate and 87.3% for denosumab.
Introduction
The purpose of this study is to evaluate treatment adherence with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly.
Methods
In this multicenter, randomized, open-label, 2-year, crossover study, 250 postmenopausal women with low bone mineral density received denosumab or alendronate for 12 months, then the other treatment for 12 months. The alendronate bottle had a medication event monitoring system cap to monitor administration dates. Definitions were as follows: compliance, receiving both denosumab doses 6 (±1) months apart or 80–100% of alendronate doses; persistence, receiving both denosumab doses and completing the month 12 visit within the visit window or ≥2 alendronate doses in the final month; adherence, achieving both compliance and persistence. This report includes data from the first 12 months.
Results
The primary study endpoint, adherence in the first 12 months, was 76.6% (95/124) for alendronate and 87.3% (110/126) for denosumab. Risk ratios for denosumab compared with alendronate at 12 months were 0.58 (
p
= 0.043) for non-adherence, 0.48 (
p
= 0.014) for non-compliance, and 0.54 (
p
= 0.049) for non-persistence. Subject ratings for treatment necessity, preference, and satisfaction were significantly greater for denosumab and ratings for treatment bother were significantly greater for alendronate. Adverse events were reported by 64.1% of alendronate-treated subjects and 72.0% of denosumab-treated subjects (
p
= 0.403). The most common adverse events were arthralgia, back pain, pain in extremity, cough, and headache (each in <10% of subjects in each group).
Conclusions
Significantly greater treatment adherence was observed for subcutaneous administration of denosumab every 6 months than for oral alendronate once weekly.</abstract><cop>London</cop><pub>Springer-Verlag</pub><pmid>20827547</pmid><doi>10.1007/s00198-010-1378-z</doi><tpages>11</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0937-941X |
| ispartof | Osteoporosis international, 2011-06, Vol.22 (6), p.1725-1735 |
| issn | 0937-941X 1433-2965 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_876225731 |
| source | MEDLINE; SpringerLink Journals |
| subjects | Administration, Oral Aged Alendronate - administration & dosage Alendronate - adverse effects Alendronate - therapeutic use Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - therapeutic use Antibodies, Monoclonal, Humanized Biological and medical sciences Bone Density - drug effects Bone Density Conservation Agents - administration & dosage Bone Density Conservation Agents - adverse effects Bone Density Conservation Agents - therapeutic use Bones, joints and connective tissue. Antiinflammatory agents British Columbia Compliance Denosumab Diseases of the osteoarticular system Drug therapy Endocrinology Epidemiologic Methods Female Humans Immunomodulators Injections, Subcutaneous Medical sciences Medication Adherence - statistics & numerical data Medicine Medicine & Public Health Middle Aged Original Article Orthopedics Osteoporosis Osteoporosis, Postmenopausal - drug therapy Osteoporosis, Postmenopausal - physiopathology Osteoporosis, Postmenopausal - psychology Osteoporosis. Osteomalacia. Paget disease Patient Preference - statistics & numerical data Patient Satisfaction - statistics & numerical data Pharmacology. Drug treatments Preferences Rheumatology Side effects Treatment Outcome Women |
| title | Adherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronate |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-31T04%3A56%3A23IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Adherence,%20preference,%20and%20satisfaction%20of%20postmenopausal%20women%20taking%20denosumab%20or%20alendronate&rft.jtitle=Osteoporosis%20international&rft.au=Kendler,%20D.%20L.&rft.aucorp=DAPS%20Investigators&rft.date=2011-06-01&rft.volume=22&rft.issue=6&rft.spage=1725&rft.epage=1735&rft.pages=1725-1735&rft.issn=0937-941X&rft.eissn=1433-2965&rft_id=info:doi/10.1007/s00198-010-1378-z&rft_dat=%3Cproquest_cross%3E2393956161%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=875539341&rft_id=info:pmid/20827547&rfr_iscdi=true |