Modeling‐Based Bone Formation After 2 Months of Romosozumab Treatment: Results From the FRAME Clinical Trial
ABSTRACT The bone‐forming agent romosozumab is a monoclonal antibody that inhibits sclerostin, leading to increased bone formation and decreased resorption. The highest levels of bone formation markers in human patients are observed in the first 2 months of treatment. Histomorphometric analysis of b...
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| Veröffentlicht in: | Journal of bone and mineral research 2022-01, Vol.37 (1), p.36-40 |
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| creator | Eriksen, Erik F Chapurlat, Roland Boyce, Rogely Waite Shi, Yifei Brown, Jacques P Horlait, Stéphane Betah, Donald Libanati, Cesar Chavassieux, Pascale |
| description | ABSTRACT
The bone‐forming agent romosozumab is a monoclonal antibody that inhibits sclerostin, leading to increased bone formation and decreased resorption. The highest levels of bone formation markers in human patients are observed in the first 2 months of treatment. Histomorphometric analysis of bone biopsies from the phase 3 FRAME trial (NCT01575834) showed an early significant increase in bone formation with concomitant decreased resorption. Preclinical studies demonstrated that most new bone formation after romosozumab treatment was modeling‐based bone formation (MBBF). Here we analyzed bone biopsies from FRAME to assess the effect of 2 months of romosozumab versus placebo on the surface extent of MBBF and remodeling‐based bone formation (RBBF). In FRAME, postmenopausal women aged ≥55 years with osteoporosis were randomized 1:1 to 210 mg romosozumab or placebo sc every month for 12 months, followed by 60 mg denosumab sc every 6 months for 12 months. Participants in the bone biopsy substudy received quadruple tetracycline labeling and underwent transiliac biopsies at month 2. A total of 29 biopsies were suitable for histomorphometry. Using fluorescence microscopy, bone formation at cancellous, endocortical, and periosteal envelopes was classified based on the appearance of underlying cement lines as modeling (smooth) or remodeling (scalloped). Data were compared using the Wilcoxon rank‐sum test, without multiplicity adjustment. After 2 months, the median percentage of MBBF referent to the total bone surface was significantly increased with romosozumab versus placebo on cancellous (18.0% versus 3.8%; p = 0.005) and endocortical (36.7% versus 3.0%; p = 0.001), but not on periosteal (5.0% versus 2.0%; p = 0.37) surfaces, with no significant difference in the surface extent of RBBF on all three bone surfaces. These data show that stimulation of bone formation in the first 2 months of romosozumab treatment in postmenopausal women with osteoporosis is predominately due to increased MBBF on endocortical and cancellous surfaces. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
Bone biopsies from the FRAME trial were analyzed to evaluate MBBF and RBBF after romosozumab treatment. After 2 months, the median percentage of MBBF referent to the total bone surface was significantly increased with romosozumab vs placebo on cancellous and endocortical, but n |
| doi_str_mv | 10.1002/jbmr.4457 |
| format | Article |
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The bone‐forming agent romosozumab is a monoclonal antibody that inhibits sclerostin, leading to increased bone formation and decreased resorption. The highest levels of bone formation markers in human patients are observed in the first 2 months of treatment. Histomorphometric analysis of bone biopsies from the phase 3 FRAME trial (NCT01575834) showed an early significant increase in bone formation with concomitant decreased resorption. Preclinical studies demonstrated that most new bone formation after romosozumab treatment was modeling‐based bone formation (MBBF). Here we analyzed bone biopsies from FRAME to assess the effect of 2 months of romosozumab versus placebo on the surface extent of MBBF and remodeling‐based bone formation (RBBF). In FRAME, postmenopausal women aged ≥55 years with osteoporosis were randomized 1:1 to 210 mg romosozumab or placebo sc every month for 12 months, followed by 60 mg denosumab sc every 6 months for 12 months. Participants in the bone biopsy substudy received quadruple tetracycline labeling and underwent transiliac biopsies at month 2. A total of 29 biopsies were suitable for histomorphometry. Using fluorescence microscopy, bone formation at cancellous, endocortical, and periosteal envelopes was classified based on the appearance of underlying cement lines as modeling (smooth) or remodeling (scalloped). Data were compared using the Wilcoxon rank‐sum test, without multiplicity adjustment. After 2 months, the median percentage of MBBF referent to the total bone surface was significantly increased with romosozumab versus placebo on cancellous (18.0% versus 3.8%; p = 0.005) and endocortical (36.7% versus 3.0%; p = 0.001), but not on periosteal (5.0% versus 2.0%; p = 0.37) surfaces, with no significant difference in the surface extent of RBBF on all three bone surfaces. These data show that stimulation of bone formation in the first 2 months of romosozumab treatment in postmenopausal women with osteoporosis is predominately due to increased MBBF on endocortical and cancellous surfaces. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
Bone biopsies from the FRAME trial were analyzed to evaluate MBBF and RBBF after romosozumab treatment. After 2 months, the median percentage of MBBF referent to the total bone surface was significantly increased with romosozumab vs placebo on cancellous and endocortical, but not periosteal surfaces, with no significant difference in the surface extent of RBBF on all three bone surfaces. MBBF, modeling‐based bone formation; RBBF, remodeling‐based bone formation</description><identifier>ISSN: 0884-0431</identifier><identifier>EISSN: 1523-4681</identifier><identifier>DOI: 10.1002/jbmr.4457</identifier><identifier>PMID: 34633116</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley & Sons, Inc</publisher><subject>Antibodies, Monoclonal - pharmacology ; Antibodies, Monoclonal - therapeutic use ; Bone Density ; Bone Density Conservation Agents - therapeutic use ; BONE HISTOMORPHOMETRY ; BONE MODELING AND REMODELING ; Female ; Humans ; Middle Aged ; Osteogenesis ; OSTEOPOROSIS ; Osteoporosis - drug therapy ; Osteoporosis, Postmenopausal - drug therapy ; THERAPEUTICS ; Wnt/β‐CATENIN/LRPs CELL/TISSUE SIGNALING</subject><ispartof>Journal of bone and mineral research, 2022-01, Vol.37 (1), p.36-40</ispartof><rights>2021 The Authors. published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).</rights><rights>2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2757-5fa3e6a22a2eea582bea1a0bea214b18a1c304089f629541c16a7247734a28e03</citedby><cites>FETCH-LOGICAL-c2757-5fa3e6a22a2eea582bea1a0bea214b18a1c304089f629541c16a7247734a28e03</cites><orcidid>0000-0001-5128-7361 ; 0000-0001-8214-6385 ; 0000-0003-1427-7839 ; 0000-0002-5945-722X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fjbmr.4457$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjbmr.4457$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,777,781,1412,27905,27906,45555,45556</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34633116$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Eriksen, Erik F</creatorcontrib><creatorcontrib>Chapurlat, Roland</creatorcontrib><creatorcontrib>Boyce, Rogely Waite</creatorcontrib><creatorcontrib>Shi, Yifei</creatorcontrib><creatorcontrib>Brown, Jacques P</creatorcontrib><creatorcontrib>Horlait, Stéphane</creatorcontrib><creatorcontrib>Betah, Donald</creatorcontrib><creatorcontrib>Libanati, Cesar</creatorcontrib><creatorcontrib>Chavassieux, Pascale</creatorcontrib><title>Modeling‐Based Bone Formation After 2 Months of Romosozumab Treatment: Results From the FRAME Clinical Trial</title><title>Journal of bone and mineral research</title><addtitle>J Bone Miner Res</addtitle><description>ABSTRACT
The bone‐forming agent romosozumab is a monoclonal antibody that inhibits sclerostin, leading to increased bone formation and decreased resorption. The highest levels of bone formation markers in human patients are observed in the first 2 months of treatment. Histomorphometric analysis of bone biopsies from the phase 3 FRAME trial (NCT01575834) showed an early significant increase in bone formation with concomitant decreased resorption. Preclinical studies demonstrated that most new bone formation after romosozumab treatment was modeling‐based bone formation (MBBF). Here we analyzed bone biopsies from FRAME to assess the effect of 2 months of romosozumab versus placebo on the surface extent of MBBF and remodeling‐based bone formation (RBBF). In FRAME, postmenopausal women aged ≥55 years with osteoporosis were randomized 1:1 to 210 mg romosozumab or placebo sc every month for 12 months, followed by 60 mg denosumab sc every 6 months for 12 months. Participants in the bone biopsy substudy received quadruple tetracycline labeling and underwent transiliac biopsies at month 2. A total of 29 biopsies were suitable for histomorphometry. Using fluorescence microscopy, bone formation at cancellous, endocortical, and periosteal envelopes was classified based on the appearance of underlying cement lines as modeling (smooth) or remodeling (scalloped). Data were compared using the Wilcoxon rank‐sum test, without multiplicity adjustment. After 2 months, the median percentage of MBBF referent to the total bone surface was significantly increased with romosozumab versus placebo on cancellous (18.0% versus 3.8%; p = 0.005) and endocortical (36.7% versus 3.0%; p = 0.001), but not on periosteal (5.0% versus 2.0%; p = 0.37) surfaces, with no significant difference in the surface extent of RBBF on all three bone surfaces. These data show that stimulation of bone formation in the first 2 months of romosozumab treatment in postmenopausal women with osteoporosis is predominately due to increased MBBF on endocortical and cancellous surfaces. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
Bone biopsies from the FRAME trial were analyzed to evaluate MBBF and RBBF after romosozumab treatment. After 2 months, the median percentage of MBBF referent to the total bone surface was significantly increased with romosozumab vs placebo on cancellous and endocortical, but not periosteal surfaces, with no significant difference in the surface extent of RBBF on all three bone surfaces. MBBF, modeling‐based bone formation; RBBF, remodeling‐based bone formation</description><subject>Antibodies, Monoclonal - pharmacology</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Bone Density</subject><subject>Bone Density Conservation Agents - therapeutic use</subject><subject>BONE HISTOMORPHOMETRY</subject><subject>BONE MODELING AND REMODELING</subject><subject>Female</subject><subject>Humans</subject><subject>Middle Aged</subject><subject>Osteogenesis</subject><subject>OSTEOPOROSIS</subject><subject>Osteoporosis - drug therapy</subject><subject>Osteoporosis, Postmenopausal - drug therapy</subject><subject>THERAPEUTICS</subject><subject>Wnt/β‐CATENIN/LRPs CELL/TISSUE SIGNALING</subject><issn>0884-0431</issn><issn>1523-4681</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp10LtOwzAUxnELgWi5DLwA8ghDWt_ipGxtRbmoFVIFc3SSntBUcVzsRAgmVjaekSchpcDGcs7y03_4CDnhrMcZE_1ValxPqTDaIV0eChkoHfNd0mVxrAKmJO-QA-9XjDEdar1POlJpKTnXXbKe2QWWRfX4-fYxAo8LOrIV0ol1BurCVnSY1-io-Hx7n9mqXnpqczq3xnr72hhI6b1DqA1W9QWdo2_K2tOJs4bWy7YyH84u6bjNFxmULS2gPCJ7OZQej3_-IXmYXN6Pr4Pp3dXNeDgNMhGFURDmIFGDECAQIYxFisCBtVdwlfIYeCaZYvEg12IQKp5xDZFQUSQViBiZPCRn2-7a2acGfZ2YwmdYllChbXwiwpgNFOOCt_R8SzNnvXeYJ2tXGHAvCWfJZuBkM3CyGbi1pz_ZJjW4-JO_i7agvwXPRYkv_5eS29Fs_p38AicqhnA</recordid><startdate>202201</startdate><enddate>202201</enddate><creator>Eriksen, Erik F</creator><creator>Chapurlat, Roland</creator><creator>Boyce, Rogely Waite</creator><creator>Shi, Yifei</creator><creator>Brown, Jacques P</creator><creator>Horlait, Stéphane</creator><creator>Betah, Donald</creator><creator>Libanati, Cesar</creator><creator>Chavassieux, Pascale</creator><general>John Wiley & Sons, Inc</general><scope>24P</scope><scope>WIN</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>7X8</scope><orcidid>https://orcid.org/0000-0001-5128-7361</orcidid><orcidid>https://orcid.org/0000-0001-8214-6385</orcidid><orcidid>https://orcid.org/0000-0003-1427-7839</orcidid><orcidid>https://orcid.org/0000-0002-5945-722X</orcidid></search><sort><creationdate>202201</creationdate><title>Modeling‐Based Bone Formation After 2 Months of Romosozumab Treatment: Results From the FRAME Clinical Trial</title><author>Eriksen, Erik F ; Chapurlat, Roland ; Boyce, Rogely Waite ; Shi, Yifei ; Brown, Jacques P ; Horlait, Stéphane ; Betah, Donald ; Libanati, Cesar ; Chavassieux, Pascale</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2757-5fa3e6a22a2eea582bea1a0bea214b18a1c304089f629541c16a7247734a28e03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Antibodies, Monoclonal - pharmacology</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Bone Density</topic><topic>Bone Density Conservation Agents - therapeutic use</topic><topic>BONE HISTOMORPHOMETRY</topic><topic>BONE MODELING AND REMODELING</topic><topic>Female</topic><topic>Humans</topic><topic>Middle Aged</topic><topic>Osteogenesis</topic><topic>OSTEOPOROSIS</topic><topic>Osteoporosis - drug therapy</topic><topic>Osteoporosis, Postmenopausal - drug therapy</topic><topic>THERAPEUTICS</topic><topic>Wnt/β‐CATENIN/LRPs CELL/TISSUE SIGNALING</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Eriksen, Erik F</creatorcontrib><creatorcontrib>Chapurlat, Roland</creatorcontrib><creatorcontrib>Boyce, Rogely Waite</creatorcontrib><creatorcontrib>Shi, Yifei</creatorcontrib><creatorcontrib>Brown, Jacques P</creatorcontrib><creatorcontrib>Horlait, Stéphane</creatorcontrib><creatorcontrib>Betah, Donald</creatorcontrib><creatorcontrib>Libanati, Cesar</creatorcontrib><creatorcontrib>Chavassieux, Pascale</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Wiley Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of bone and mineral research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Eriksen, Erik F</au><au>Chapurlat, Roland</au><au>Boyce, Rogely Waite</au><au>Shi, Yifei</au><au>Brown, Jacques P</au><au>Horlait, Stéphane</au><au>Betah, Donald</au><au>Libanati, Cesar</au><au>Chavassieux, Pascale</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Modeling‐Based Bone Formation After 2 Months of Romosozumab Treatment: Results From the FRAME Clinical Trial</atitle><jtitle>Journal of bone and mineral research</jtitle><addtitle>J Bone Miner Res</addtitle><date>2022-01</date><risdate>2022</risdate><volume>37</volume><issue>1</issue><spage>36</spage><epage>40</epage><pages>36-40</pages><issn>0884-0431</issn><eissn>1523-4681</eissn><abstract>ABSTRACT
The bone‐forming agent romosozumab is a monoclonal antibody that inhibits sclerostin, leading to increased bone formation and decreased resorption. The highest levels of bone formation markers in human patients are observed in the first 2 months of treatment. Histomorphometric analysis of bone biopsies from the phase 3 FRAME trial (NCT01575834) showed an early significant increase in bone formation with concomitant decreased resorption. Preclinical studies demonstrated that most new bone formation after romosozumab treatment was modeling‐based bone formation (MBBF). Here we analyzed bone biopsies from FRAME to assess the effect of 2 months of romosozumab versus placebo on the surface extent of MBBF and remodeling‐based bone formation (RBBF). In FRAME, postmenopausal women aged ≥55 years with osteoporosis were randomized 1:1 to 210 mg romosozumab or placebo sc every month for 12 months, followed by 60 mg denosumab sc every 6 months for 12 months. Participants in the bone biopsy substudy received quadruple tetracycline labeling and underwent transiliac biopsies at month 2. A total of 29 biopsies were suitable for histomorphometry. Using fluorescence microscopy, bone formation at cancellous, endocortical, and periosteal envelopes was classified based on the appearance of underlying cement lines as modeling (smooth) or remodeling (scalloped). Data were compared using the Wilcoxon rank‐sum test, without multiplicity adjustment. After 2 months, the median percentage of MBBF referent to the total bone surface was significantly increased with romosozumab versus placebo on cancellous (18.0% versus 3.8%; p = 0.005) and endocortical (36.7% versus 3.0%; p = 0.001), but not on periosteal (5.0% versus 2.0%; p = 0.37) surfaces, with no significant difference in the surface extent of RBBF on all three bone surfaces. These data show that stimulation of bone formation in the first 2 months of romosozumab treatment in postmenopausal women with osteoporosis is predominately due to increased MBBF on endocortical and cancellous surfaces. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
Bone biopsies from the FRAME trial were analyzed to evaluate MBBF and RBBF after romosozumab treatment. After 2 months, the median percentage of MBBF referent to the total bone surface was significantly increased with romosozumab vs placebo on cancellous and endocortical, but not periosteal surfaces, with no significant difference in the surface extent of RBBF on all three bone surfaces. MBBF, modeling‐based bone formation; RBBF, remodeling‐based bone formation</abstract><cop>Hoboken, USA</cop><pub>John Wiley & Sons, Inc</pub><pmid>34633116</pmid><doi>10.1002/jbmr.4457</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0001-5128-7361</orcidid><orcidid>https://orcid.org/0000-0001-8214-6385</orcidid><orcidid>https://orcid.org/0000-0003-1427-7839</orcidid><orcidid>https://orcid.org/0000-0002-5945-722X</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Antibodies, Monoclonal - pharmacology Antibodies, Monoclonal - therapeutic use Bone Density Bone Density Conservation Agents - therapeutic use BONE HISTOMORPHOMETRY BONE MODELING AND REMODELING Female Humans Middle Aged Osteogenesis OSTEOPOROSIS Osteoporosis - drug therapy Osteoporosis, Postmenopausal - drug therapy THERAPEUTICS Wnt/β‐CATENIN/LRPs CELL/TISSUE SIGNALING |
| title | Modeling‐Based Bone Formation After 2 Months of Romosozumab Treatment: Results From the FRAME Clinical Trial |
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