Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study—Asian Subgroup Analysis
Introduction The primary analysis of a global phase 3 study that evaluated the efficacy and safety of denosumab versus zoledronic acid for preventing skeletal-related events (SREs) in adults with newly diagnosed multiple myeloma (MM) indicated that denosumab was noninferior to zoledronic acid for ti...
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| creator | Huang, Shang-Yi Yoon, Sung-Soo Shimizu, Kazuyuki Chng, Wee Joo Chang, Cheng-Shyong Wong, Raymond Siu-Ming Gao, Seasea Wang, Yang Gordon, Steve W. Glennane, Anthony Min, Chang-Ki |
| description | Introduction
The primary analysis of a global phase 3 study that evaluated the efficacy and safety of denosumab versus zoledronic acid for preventing skeletal-related events (SREs) in adults with newly diagnosed multiple myeloma (MM) indicated that denosumab was noninferior to zoledronic acid for time to first on-study SREs. Here we present a subgroup analysis to evaluate efficacy and safety in Asian patients.
Methods
Patients were randomized 1:1 to receive denosumab 120 mg subcutaneously or zoledronic acid intravenously 4 mg every 4 weeks in a double-blind, double-dummy fashion. All patients received standard-of-care first-line antimyeloma treatment. Each patient received either study drug until an estimated 676 patients experienced at least one on-study SRE and the primary efficacy and safety analyses were completed.
Results
Of 1718 total enrolled patients, 196 Asian patients (denosumab,
n
= 103; zoledronic acid,
n
= 93) were included in this subgroup analysis. Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48–1.26]). All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE. The most common AEs reported in either group (denosumab, zoledronic acid) were diarrhea (51.0%, 51.1%), nausea (42.2%, 46.7%), and pyrexia (38.2%, 41.3%). Treatment-emergent renal toxicity occurred in 9/102 (8.8%) and 20/92 (21.7%) patients, respectively. Similar rates of positively adjudicated osteonecrosis of the jaw (7 [6.9%] vs 5 [5.4%]) and treatment-emergent hypocalcemia (19 [18.6%] vs 17 [18.5%]) were reported in the denosumab and zoledronic acid groups, respectively.
Conclusion
Efficacy and safety outcomes from this Asian subgroup were comparable to those of the full study population. Overall, this analysis supports denosumab as an additional treatment option for standard of care for Asian patients with newly diagnosed MM with lytic bone lesions.
Clinical Trial Registration
ClinicalTrials.gov NCT01345019. |
| doi_str_mv | 10.1007/s12325-020-01395-x |
| format | Article |
| fullrecord | <record><control><sourceid>pubmed_cross</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7467415</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>32524500</sourcerecordid><originalsourceid>FETCH-LOGICAL-c446t-915b33bd003c8231898371f9c9ca5a6deb88b02bd14a2be03332b122223430ab3</originalsourceid><addsrcrecordid>eNp9kU1uFDEUhC0EIkPgAiyQDxCDf7qnu1kgTWb4iZQAIgEhNpbdfjNx5LZHdhvSrDgEB-AkLDgKJ8EwEMEGS5YXVfU9PRdCdxm9zyhtHiTGBa8J5ZRQJrqaXF5DM9bOa1Iuv45mtKkY4aJ9u4dupXRBi7Op25tor8R4VVM6Q19X4EPKg9L4DcSUE34XHJgYvO3xorcGW48Pgwe8sglUAnwWQY0D-BGHNX4OH9xUJLUpFDD4JLvRbh3gkwlcGNRDvPD4yI8QvRpt8Mod4FXI2gE5dNabA_xKeRMG-7GEl8GPMbgyHr88L6O-fRH4dMxm-v7p8yJZ5fFp1psY8rZQlZuSTbfRjbVyCe78fvfR6yePz5bPyPGLp0fLxTHpq2o-ko7VWghtKBV9ywVru1Y0bN31Xa9qNTeg21ZTrg2rFNdAhRBcM16OqARVWuyjRzvuNusBTF_Wj8rJbbSDipMMysp_FW_P5Sa8l001LyXUBcB3gD6GlCKsr7KMyp9tyl2bsnQkf7UpL0vo3t9TryJ_6isGsTOkIvkNRHkRcvlql_6H_QHwoLGH</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study—Asian Subgroup Analysis</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Huang, Shang-Yi ; Yoon, Sung-Soo ; Shimizu, Kazuyuki ; Chng, Wee Joo ; Chang, Cheng-Shyong ; Wong, Raymond Siu-Ming ; Gao, Seasea ; Wang, Yang ; Gordon, Steve W. ; Glennane, Anthony ; Min, Chang-Ki</creator><creatorcontrib>Huang, Shang-Yi ; Yoon, Sung-Soo ; Shimizu, Kazuyuki ; Chng, Wee Joo ; Chang, Cheng-Shyong ; Wong, Raymond Siu-Ming ; Gao, Seasea ; Wang, Yang ; Gordon, Steve W. ; Glennane, Anthony ; Min, Chang-Ki</creatorcontrib><description>Introduction
The primary analysis of a global phase 3 study that evaluated the efficacy and safety of denosumab versus zoledronic acid for preventing skeletal-related events (SREs) in adults with newly diagnosed multiple myeloma (MM) indicated that denosumab was noninferior to zoledronic acid for time to first on-study SREs. Here we present a subgroup analysis to evaluate efficacy and safety in Asian patients.
Methods
Patients were randomized 1:1 to receive denosumab 120 mg subcutaneously or zoledronic acid intravenously 4 mg every 4 weeks in a double-blind, double-dummy fashion. All patients received standard-of-care first-line antimyeloma treatment. Each patient received either study drug until an estimated 676 patients experienced at least one on-study SRE and the primary efficacy and safety analyses were completed.
Results
Of 1718 total enrolled patients, 196 Asian patients (denosumab,
n
= 103; zoledronic acid,
n
= 93) were included in this subgroup analysis. Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48–1.26]). All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE. The most common AEs reported in either group (denosumab, zoledronic acid) were diarrhea (51.0%, 51.1%), nausea (42.2%, 46.7%), and pyrexia (38.2%, 41.3%). Treatment-emergent renal toxicity occurred in 9/102 (8.8%) and 20/92 (21.7%) patients, respectively. Similar rates of positively adjudicated osteonecrosis of the jaw (7 [6.9%] vs 5 [5.4%]) and treatment-emergent hypocalcemia (19 [18.6%] vs 17 [18.5%]) were reported in the denosumab and zoledronic acid groups, respectively.
Conclusion
Efficacy and safety outcomes from this Asian subgroup were comparable to those of the full study population. Overall, this analysis supports denosumab as an additional treatment option for standard of care for Asian patients with newly diagnosed MM with lytic bone lesions.
Clinical Trial Registration
ClinicalTrials.gov NCT01345019.</description><identifier>ISSN: 0741-238X</identifier><identifier>EISSN: 1865-8652</identifier><identifier>DOI: 10.1007/s12325-020-01395-x</identifier><identifier>PMID: 32524500</identifier><language>eng</language><publisher>Cheshire: Springer Healthcare</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Asian Continental Ancestry Group - statistics & numerical data ; Bone Density Conservation Agents - administration & dosage ; Bone Density Conservation Agents - therapeutic use ; Bone Neoplasms - drug therapy ; Bone Neoplasms - etiology ; Brief Report ; Cardiology ; Denosumab - adverse effects ; Denosumab - therapeutic use ; Double-Blind Method ; Endocrinology ; Female ; Humans ; Internal Medicine ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Multiple Myeloma - complications ; Oncology ; Pharmacology/Toxicology ; Rheumatology ; Treatment Outcome ; Zoledronic Acid - therapeutic use</subject><ispartof>Advances in therapy, 2020-07, Vol.37 (7), p.3404-3416</ispartof><rights>The Author(s) 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c446t-915b33bd003c8231898371f9c9ca5a6deb88b02bd14a2be03332b122223430ab3</citedby><cites>FETCH-LOGICAL-c446t-915b33bd003c8231898371f9c9ca5a6deb88b02bd14a2be03332b122223430ab3</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/s12325-020-01395-x$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12325-020-01395-x$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,27923,27924,41487,42556,51318</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32524500$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Huang, Shang-Yi</creatorcontrib><creatorcontrib>Yoon, Sung-Soo</creatorcontrib><creatorcontrib>Shimizu, Kazuyuki</creatorcontrib><creatorcontrib>Chng, Wee Joo</creatorcontrib><creatorcontrib>Chang, Cheng-Shyong</creatorcontrib><creatorcontrib>Wong, Raymond Siu-Ming</creatorcontrib><creatorcontrib>Gao, Seasea</creatorcontrib><creatorcontrib>Wang, Yang</creatorcontrib><creatorcontrib>Gordon, Steve W.</creatorcontrib><creatorcontrib>Glennane, Anthony</creatorcontrib><creatorcontrib>Min, Chang-Ki</creatorcontrib><title>Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study—Asian Subgroup Analysis</title><title>Advances in therapy</title><addtitle>Adv Ther</addtitle><addtitle>Adv Ther</addtitle><description>Introduction
The primary analysis of a global phase 3 study that evaluated the efficacy and safety of denosumab versus zoledronic acid for preventing skeletal-related events (SREs) in adults with newly diagnosed multiple myeloma (MM) indicated that denosumab was noninferior to zoledronic acid for time to first on-study SREs. Here we present a subgroup analysis to evaluate efficacy and safety in Asian patients.
Methods
Patients were randomized 1:1 to receive denosumab 120 mg subcutaneously or zoledronic acid intravenously 4 mg every 4 weeks in a double-blind, double-dummy fashion. All patients received standard-of-care first-line antimyeloma treatment. Each patient received either study drug until an estimated 676 patients experienced at least one on-study SRE and the primary efficacy and safety analyses were completed.
Results
Of 1718 total enrolled patients, 196 Asian patients (denosumab,
n
= 103; zoledronic acid,
n
= 93) were included in this subgroup analysis. Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48–1.26]). All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE. The most common AEs reported in either group (denosumab, zoledronic acid) were diarrhea (51.0%, 51.1%), nausea (42.2%, 46.7%), and pyrexia (38.2%, 41.3%). Treatment-emergent renal toxicity occurred in 9/102 (8.8%) and 20/92 (21.7%) patients, respectively. Similar rates of positively adjudicated osteonecrosis of the jaw (7 [6.9%] vs 5 [5.4%]) and treatment-emergent hypocalcemia (19 [18.6%] vs 17 [18.5%]) were reported in the denosumab and zoledronic acid groups, respectively.
Conclusion
Efficacy and safety outcomes from this Asian subgroup were comparable to those of the full study population. Overall, this analysis supports denosumab as an additional treatment option for standard of care for Asian patients with newly diagnosed MM with lytic bone lesions.
Clinical Trial Registration
ClinicalTrials.gov NCT01345019.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Asian Continental Ancestry Group - statistics & numerical data</subject><subject>Bone Density Conservation Agents - administration & dosage</subject><subject>Bone Density Conservation Agents - therapeutic use</subject><subject>Bone Neoplasms - drug therapy</subject><subject>Bone Neoplasms - etiology</subject><subject>Brief Report</subject><subject>Cardiology</subject><subject>Denosumab - adverse effects</subject><subject>Denosumab - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Endocrinology</subject><subject>Female</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Multiple Myeloma - complications</subject><subject>Oncology</subject><subject>Pharmacology/Toxicology</subject><subject>Rheumatology</subject><subject>Treatment Outcome</subject><subject>Zoledronic Acid - therapeutic use</subject><issn>0741-238X</issn><issn>1865-8652</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><recordid>eNp9kU1uFDEUhC0EIkPgAiyQDxCDf7qnu1kgTWb4iZQAIgEhNpbdfjNx5LZHdhvSrDgEB-AkLDgKJ8EwEMEGS5YXVfU9PRdCdxm9zyhtHiTGBa8J5ZRQJrqaXF5DM9bOa1Iuv45mtKkY4aJ9u4dupXRBi7Op25tor8R4VVM6Q19X4EPKg9L4DcSUE34XHJgYvO3xorcGW48Pgwe8sglUAnwWQY0D-BGHNX4OH9xUJLUpFDD4JLvRbh3gkwlcGNRDvPD4yI8QvRpt8Mod4FXI2gE5dNabA_xKeRMG-7GEl8GPMbgyHr88L6O-fRH4dMxm-v7p8yJZ5fFp1psY8rZQlZuSTbfRjbVyCe78fvfR6yePz5bPyPGLp0fLxTHpq2o-ko7VWghtKBV9ywVru1Y0bN31Xa9qNTeg21ZTrg2rFNdAhRBcM16OqARVWuyjRzvuNusBTF_Wj8rJbbSDipMMysp_FW_P5Sa8l001LyXUBcB3gD6GlCKsr7KMyp9tyl2bsnQkf7UpL0vo3t9TryJ_6isGsTOkIvkNRHkRcvlql_6H_QHwoLGH</recordid><startdate>20200701</startdate><enddate>20200701</enddate><creator>Huang, Shang-Yi</creator><creator>Yoon, Sung-Soo</creator><creator>Shimizu, Kazuyuki</creator><creator>Chng, Wee Joo</creator><creator>Chang, Cheng-Shyong</creator><creator>Wong, Raymond Siu-Ming</creator><creator>Gao, Seasea</creator><creator>Wang, Yang</creator><creator>Gordon, Steve W.</creator><creator>Glennane, Anthony</creator><creator>Min, Chang-Ki</creator><general>Springer Healthcare</general><scope>C6C</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>5PM</scope></search><sort><creationdate>20200701</creationdate><title>Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study—Asian Subgroup Analysis</title><author>Huang, Shang-Yi ; Yoon, Sung-Soo ; Shimizu, Kazuyuki ; Chng, Wee Joo ; Chang, Cheng-Shyong ; Wong, Raymond Siu-Ming ; Gao, Seasea ; Wang, Yang ; Gordon, Steve W. ; Glennane, Anthony ; Min, Chang-Ki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c446t-915b33bd003c8231898371f9c9ca5a6deb88b02bd14a2be03332b122223430ab3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Asian Continental Ancestry Group - statistics & numerical data</topic><topic>Bone Density Conservation Agents - administration & dosage</topic><topic>Bone Density Conservation Agents - therapeutic use</topic><topic>Bone Neoplasms - drug therapy</topic><topic>Bone Neoplasms - etiology</topic><topic>Brief Report</topic><topic>Cardiology</topic><topic>Denosumab - adverse effects</topic><topic>Denosumab - therapeutic use</topic><topic>Double-Blind Method</topic><topic>Endocrinology</topic><topic>Female</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Multiple Myeloma - complications</topic><topic>Oncology</topic><topic>Pharmacology/Toxicology</topic><topic>Rheumatology</topic><topic>Treatment Outcome</topic><topic>Zoledronic Acid - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Huang, Shang-Yi</creatorcontrib><creatorcontrib>Yoon, Sung-Soo</creatorcontrib><creatorcontrib>Shimizu, Kazuyuki</creatorcontrib><creatorcontrib>Chng, Wee Joo</creatorcontrib><creatorcontrib>Chang, Cheng-Shyong</creatorcontrib><creatorcontrib>Wong, Raymond Siu-Ming</creatorcontrib><creatorcontrib>Gao, Seasea</creatorcontrib><creatorcontrib>Wang, Yang</creatorcontrib><creatorcontrib>Gordon, Steve W.</creatorcontrib><creatorcontrib>Glennane, Anthony</creatorcontrib><creatorcontrib>Min, Chang-Ki</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Advances in therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Huang, Shang-Yi</au><au>Yoon, Sung-Soo</au><au>Shimizu, Kazuyuki</au><au>Chng, Wee Joo</au><au>Chang, Cheng-Shyong</au><au>Wong, Raymond Siu-Ming</au><au>Gao, Seasea</au><au>Wang, Yang</au><au>Gordon, Steve W.</au><au>Glennane, Anthony</au><au>Min, Chang-Ki</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study—Asian Subgroup Analysis</atitle><jtitle>Advances in therapy</jtitle><stitle>Adv Ther</stitle><addtitle>Adv Ther</addtitle><date>2020-07-01</date><risdate>2020</risdate><volume>37</volume><issue>7</issue><spage>3404</spage><epage>3416</epage><pages>3404-3416</pages><issn>0741-238X</issn><eissn>1865-8652</eissn><abstract>Introduction
The primary analysis of a global phase 3 study that evaluated the efficacy and safety of denosumab versus zoledronic acid for preventing skeletal-related events (SREs) in adults with newly diagnosed multiple myeloma (MM) indicated that denosumab was noninferior to zoledronic acid for time to first on-study SREs. Here we present a subgroup analysis to evaluate efficacy and safety in Asian patients.
Methods
Patients were randomized 1:1 to receive denosumab 120 mg subcutaneously or zoledronic acid intravenously 4 mg every 4 weeks in a double-blind, double-dummy fashion. All patients received standard-of-care first-line antimyeloma treatment. Each patient received either study drug until an estimated 676 patients experienced at least one on-study SRE and the primary efficacy and safety analyses were completed.
Results
Of 1718 total enrolled patients, 196 Asian patients (denosumab,
n
= 103; zoledronic acid,
n
= 93) were included in this subgroup analysis. Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48–1.26]). All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE. The most common AEs reported in either group (denosumab, zoledronic acid) were diarrhea (51.0%, 51.1%), nausea (42.2%, 46.7%), and pyrexia (38.2%, 41.3%). Treatment-emergent renal toxicity occurred in 9/102 (8.8%) and 20/92 (21.7%) patients, respectively. Similar rates of positively adjudicated osteonecrosis of the jaw (7 [6.9%] vs 5 [5.4%]) and treatment-emergent hypocalcemia (19 [18.6%] vs 17 [18.5%]) were reported in the denosumab and zoledronic acid groups, respectively.
Conclusion
Efficacy and safety outcomes from this Asian subgroup were comparable to those of the full study population. Overall, this analysis supports denosumab as an additional treatment option for standard of care for Asian patients with newly diagnosed MM with lytic bone lesions.
Clinical Trial Registration
ClinicalTrials.gov NCT01345019.</abstract><cop>Cheshire</cop><pub>Springer Healthcare</pub><pmid>32524500</pmid><doi>10.1007/s12325-020-01395-x</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Aged, 80 and over Asian Continental Ancestry Group - statistics & numerical data Bone Density Conservation Agents - administration & dosage Bone Density Conservation Agents - therapeutic use Bone Neoplasms - drug therapy Bone Neoplasms - etiology Brief Report Cardiology Denosumab - adverse effects Denosumab - therapeutic use Double-Blind Method Endocrinology Female Humans Internal Medicine Male Medicine Medicine & Public Health Middle Aged Multiple Myeloma - complications Oncology Pharmacology/Toxicology Rheumatology Treatment Outcome Zoledronic Acid - therapeutic use |
| title | Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study—Asian Subgroup Analysis |
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