Efficacy of teriparatide compared with risedronate on FRAX®-defined major osteoporotic fractures: results of the VERO clinical trial
Summary FRAX ® calculates the 10-year probability of major osteoporotic fractures (MOF), which are considered to have a greater clinical impact than other fractures. Our results suggest that, in postmenopausal women with severe osteoporosis, those treated with teriparatide had a 60% lower risk of FR...
Gespeichert in:
| Veröffentlicht in: | Osteoporosis international 2020-10, Vol.31 (10), p.1935-1942 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 1942 |
|---|---|
| container_issue | 10 |
| container_start_page | 1935 |
| container_title | Osteoporosis international |
| container_volume | 31 |
| creator | Body, J.-J. Marin, F. Kendler, D.L. Zerbini, C.A.F. López-Romero, P. Möricke, R. Casado, E. Fahrleitner-Pammer, A. Stepan, J.J. Lespessailles, E. Minisola, S. Geusens, P. |
| description | Summary
FRAX
®
calculates the 10-year probability of major osteoporotic fractures (MOF), which are considered to have a greater clinical impact than other fractures. Our results suggest that, in postmenopausal women with severe osteoporosis, those treated with teriparatide had a 60% lower risk of FRAX
®
-defined MOF compared with those treated with risedronate.
Introduction
The VERO trial was an active-controlled fracture endpoint clinical trial that enrolled postmenopausal women with severe osteoporosis. After 24 months, a 52% reduction in the hazard ratio (HR) of clinical fractures was reported in patients randomized to teriparatide compared with risedronate. We examined fracture results restricted to FRAX
®
-defined major osteoporotic fractures (MOF), which include clinical vertebral, hip, humerus, and forearm fractures.
Methods
In total, 1360 postmenopausal women (mean age 72.1 years) were randomized to receive subcutaneous daily teriparatide (20 μg) or oral weekly risedronate (35 mg). Patient cumulative incidence of ≥ 1 FRAX
®
-defined MOF and of all clinical fractures were estimated by Kaplan-Meier analyses, and the comparison between treatments was based on the stratified log-rank test. Additionally, an extended Cox model was used to estimate HRs at different time points. Incidence fracture rates were estimated at each 6-month interval.
Results
After 24 months, 16 (2.6%) patients in the teriparatide group had ≥ 1 low trauma FRAX
®
-defined MOF compared with 40 patients (6.4%) in the risedronate group (HR 0.40; 95% CI 0.23–0.68;
p
= 0.001). Clinical vertebral and radius fractures were the most frequent FRAX
®
-defined MOF sites. The largest difference in incidence rates of both FRAX
®
-defined MOF and all clinical fractures between treatments occurred during the 6- to 12-month period. There was a statistically significant reduction in fractures between groups as early as 7 months for both categories of clinical fractures analyzed.
Conclusion
In postmenopausal women with severe osteoporosis, treatment with teriparatide was more efficacious than risedronate, with a 60% lower risk of FRAX
®
-defined MOF during the 24-month treatment period. Fracture risk was statistically significantly reduced at 7 months of treatment.
Clinical trial information
ClinicalTrials.gov
Identifier: NCT01709110
EudraCT Number: 2012-000123-41 |
| doi_str_mv | 10.1007/s00198-020-05463-4 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7497508</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2408542456</sourcerecordid><originalsourceid>FETCH-LOGICAL-c508t-7e188188b3fa97c3365010b806c3ac6da90e59e449c03d280d41e8d7f2edf63</originalsourceid><addsrcrecordid>eNp9ktFqFDEUhgdR7Lb6Al5IwBt7MZpMMpOJF8JStlZYKFSR3oVsctLNMjNZk0ylD-Dr-BA-mZlOrdoLISQh5_vPOTn8RfGC4DcEY_42YkxEW-IKl7hmDS3Zo2JBGKVlJZr6cbHAgvJSMHJ5UBzGuMNZJAR_WhzQinHW1HhRfF9Z67TSN8hblCC4vQoqOQNI-z7fwaBvLm1RcBFM8INKgPyATi-Wlz9_lAasGzLSq50PyMcEfu-DT04jG5ROY4D4DuVt7FK8rbAF9GV1cY5054Zct0MpONU9K55Y1UV4fnceFZ9OV59Pzsr1-YePJ8t1qWvcppIDadu8NtQqwTWl-QsEb1rcaKp0Y5TAUAtgTGhMTdViwwi0htsKjG3oUfF-zrofNz0YDUMKqpP74HoVbqRXTv4bGdxWXvlryZnguYGc4HhOsH0gO1uu5fSG82Bx29TXJLOv74oF_3WEmGTvooauUwP4McoJrFnF6qmvVw_QnR_DkAeRKVY1LefVRFUzpYOPMYC974BgOflBzn6Q2Q_y1g-SZdHLv798L_ltgAzQGYg5NFxB-FP7P2l_ATG9wt0</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2442687726</pqid></control><display><type>article</type><title>Efficacy of teriparatide compared with risedronate on FRAX®-defined major osteoporotic fractures: results of the VERO clinical trial</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Body, J.-J. ; Marin, F. ; Kendler, D.L. ; Zerbini, C.A.F. ; López-Romero, P. ; Möricke, R. ; Casado, E. ; Fahrleitner-Pammer, A. ; Stepan, J.J. ; Lespessailles, E. ; Minisola, S. ; Geusens, P.</creator><creatorcontrib>Body, J.-J. ; Marin, F. ; Kendler, D.L. ; Zerbini, C.A.F. ; López-Romero, P. ; Möricke, R. ; Casado, E. ; Fahrleitner-Pammer, A. ; Stepan, J.J. ; Lespessailles, E. ; Minisola, S. ; Geusens, P.</creatorcontrib><description>Summary
FRAX
®
calculates the 10-year probability of major osteoporotic fractures (MOF), which are considered to have a greater clinical impact than other fractures. Our results suggest that, in postmenopausal women with severe osteoporosis, those treated with teriparatide had a 60% lower risk of FRAX
®
-defined MOF compared with those treated with risedronate.
Introduction
The VERO trial was an active-controlled fracture endpoint clinical trial that enrolled postmenopausal women with severe osteoporosis. After 24 months, a 52% reduction in the hazard ratio (HR) of clinical fractures was reported in patients randomized to teriparatide compared with risedronate. We examined fracture results restricted to FRAX
®
-defined major osteoporotic fractures (MOF), which include clinical vertebral, hip, humerus, and forearm fractures.
Methods
In total, 1360 postmenopausal women (mean age 72.1 years) were randomized to receive subcutaneous daily teriparatide (20 μg) or oral weekly risedronate (35 mg). Patient cumulative incidence of ≥ 1 FRAX
®
-defined MOF and of all clinical fractures were estimated by Kaplan-Meier analyses, and the comparison between treatments was based on the stratified log-rank test. Additionally, an extended Cox model was used to estimate HRs at different time points. Incidence fracture rates were estimated at each 6-month interval.
Results
After 24 months, 16 (2.6%) patients in the teriparatide group had ≥ 1 low trauma FRAX
®
-defined MOF compared with 40 patients (6.4%) in the risedronate group (HR 0.40; 95% CI 0.23–0.68;
p
= 0.001). Clinical vertebral and radius fractures were the most frequent FRAX
®
-defined MOF sites. The largest difference in incidence rates of both FRAX
®
-defined MOF and all clinical fractures between treatments occurred during the 6- to 12-month period. There was a statistically significant reduction in fractures between groups as early as 7 months for both categories of clinical fractures analyzed.
Conclusion
In postmenopausal women with severe osteoporosis, treatment with teriparatide was more efficacious than risedronate, with a 60% lower risk of FRAX
®
-defined MOF during the 24-month treatment period. Fracture risk was statistically significantly reduced at 7 months of treatment.
Clinical trial information
ClinicalTrials.gov
Identifier: NCT01709110
EudraCT Number: 2012-000123-41</description><identifier>ISSN: 0937-941X</identifier><identifier>EISSN: 1433-2965</identifier><identifier>DOI: 10.1007/s00198-020-05463-4</identifier><identifier>PMID: 32474650</identifier><language>eng</language><publisher>London: Springer London</publisher><subject>Aged ; Bisphosphonates ; Bone Density ; Bone Density Conservation Agents - therapeutic use ; Clinical trials ; Double-Blind Method ; Endocrinology ; Female ; Forearm ; Fractures ; Human health and pathology ; Humans ; Humerus ; Life Sciences ; Medicine ; Medicine & Public Health ; Original ; Original Article ; Orthopedics ; Osteoporosis ; Osteoporosis, Postmenopausal - drug therapy ; Osteoporotic Fractures - epidemiology ; Osteoporotic Fractures - etiology ; Osteoporotic Fractures - prevention & control ; Parathyroid hormone ; Patients ; Post-menopause ; Rheumatology ; Rhumatology and musculoskeletal system ; Risedronic acid ; Risedronic Acid - therapeutic use ; Risk assessment ; Statistical analysis ; Teriparatide - therapeutic use ; Trauma ; Vertebrae</subject><ispartof>Osteoporosis international, 2020-10, Vol.31 (10), p.1935-1942</ispartof><rights>The Author(s) 2020</rights><rights>The Author(s) 2020. This work is published under https://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c508t-7e188188b3fa97c3365010b806c3ac6da90e59e449c03d280d41e8d7f2edf63</citedby><cites>FETCH-LOGICAL-c508t-7e188188b3fa97c3365010b806c3ac6da90e59e449c03d280d41e8d7f2edf63</cites><orcidid>0000-0001-7679-3965 ; 0000-0001-6269-2354 ; 0000-0001-6525-0439 ; 0000-0002-9165-1444 ; 0000-0001-8839-6430 ; 0000-0003-2899-9840 ; 0000-0001-8830-9974 ; 0000-0002-7547-9146 ; 0000-0001-9066-1109 ; 0000-0003-1541-8306 ; 0000-0002-5590-0888 ; 0000-0003-1009-8518</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00198-020-05463-4$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00198-020-05463-4$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32474650$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-03240865$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Body, J.-J.</creatorcontrib><creatorcontrib>Marin, F.</creatorcontrib><creatorcontrib>Kendler, D.L.</creatorcontrib><creatorcontrib>Zerbini, C.A.F.</creatorcontrib><creatorcontrib>López-Romero, P.</creatorcontrib><creatorcontrib>Möricke, R.</creatorcontrib><creatorcontrib>Casado, E.</creatorcontrib><creatorcontrib>Fahrleitner-Pammer, A.</creatorcontrib><creatorcontrib>Stepan, J.J.</creatorcontrib><creatorcontrib>Lespessailles, E.</creatorcontrib><creatorcontrib>Minisola, S.</creatorcontrib><creatorcontrib>Geusens, P.</creatorcontrib><title>Efficacy of teriparatide compared with risedronate on FRAX®-defined major osteoporotic fractures: results of the VERO clinical trial</title><title>Osteoporosis international</title><addtitle>Osteoporos Int</addtitle><addtitle>Osteoporos Int</addtitle><description>Summary
FRAX
®
calculates the 10-year probability of major osteoporotic fractures (MOF), which are considered to have a greater clinical impact than other fractures. Our results suggest that, in postmenopausal women with severe osteoporosis, those treated with teriparatide had a 60% lower risk of FRAX
®
-defined MOF compared with those treated with risedronate.
Introduction
The VERO trial was an active-controlled fracture endpoint clinical trial that enrolled postmenopausal women with severe osteoporosis. After 24 months, a 52% reduction in the hazard ratio (HR) of clinical fractures was reported in patients randomized to teriparatide compared with risedronate. We examined fracture results restricted to FRAX
®
-defined major osteoporotic fractures (MOF), which include clinical vertebral, hip, humerus, and forearm fractures.
Methods
In total, 1360 postmenopausal women (mean age 72.1 years) were randomized to receive subcutaneous daily teriparatide (20 μg) or oral weekly risedronate (35 mg). Patient cumulative incidence of ≥ 1 FRAX
®
-defined MOF and of all clinical fractures were estimated by Kaplan-Meier analyses, and the comparison between treatments was based on the stratified log-rank test. Additionally, an extended Cox model was used to estimate HRs at different time points. Incidence fracture rates were estimated at each 6-month interval.
Results
After 24 months, 16 (2.6%) patients in the teriparatide group had ≥ 1 low trauma FRAX
®
-defined MOF compared with 40 patients (6.4%) in the risedronate group (HR 0.40; 95% CI 0.23–0.68;
p
= 0.001). Clinical vertebral and radius fractures were the most frequent FRAX
®
-defined MOF sites. The largest difference in incidence rates of both FRAX
®
-defined MOF and all clinical fractures between treatments occurred during the 6- to 12-month period. There was a statistically significant reduction in fractures between groups as early as 7 months for both categories of clinical fractures analyzed.
Conclusion
In postmenopausal women with severe osteoporosis, treatment with teriparatide was more efficacious than risedronate, with a 60% lower risk of FRAX
®
-defined MOF during the 24-month treatment period. Fracture risk was statistically significantly reduced at 7 months of treatment.
Clinical trial information
ClinicalTrials.gov
Identifier: NCT01709110
EudraCT Number: 2012-000123-41</description><subject>Aged</subject><subject>Bisphosphonates</subject><subject>Bone Density</subject><subject>Bone Density Conservation Agents - therapeutic use</subject><subject>Clinical trials</subject><subject>Double-Blind Method</subject><subject>Endocrinology</subject><subject>Female</subject><subject>Forearm</subject><subject>Fractures</subject><subject>Human health and pathology</subject><subject>Humans</subject><subject>Humerus</subject><subject>Life Sciences</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Original</subject><subject>Original Article</subject><subject>Orthopedics</subject><subject>Osteoporosis</subject><subject>Osteoporosis, Postmenopausal - drug therapy</subject><subject>Osteoporotic Fractures - epidemiology</subject><subject>Osteoporotic Fractures - etiology</subject><subject>Osteoporotic Fractures - prevention & control</subject><subject>Parathyroid hormone</subject><subject>Patients</subject><subject>Post-menopause</subject><subject>Rheumatology</subject><subject>Rhumatology and musculoskeletal system</subject><subject>Risedronic acid</subject><subject>Risedronic Acid - therapeutic use</subject><subject>Risk assessment</subject><subject>Statistical analysis</subject><subject>Teriparatide - therapeutic use</subject><subject>Trauma</subject><subject>Vertebrae</subject><issn>0937-941X</issn><issn>1433-2965</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9ktFqFDEUhgdR7Lb6Al5IwBt7MZpMMpOJF8JStlZYKFSR3oVsctLNMjNZk0ylD-Dr-BA-mZlOrdoLISQh5_vPOTn8RfGC4DcEY_42YkxEW-IKl7hmDS3Zo2JBGKVlJZr6cbHAgvJSMHJ5UBzGuMNZJAR_WhzQinHW1HhRfF9Z67TSN8hblCC4vQoqOQNI-z7fwaBvLm1RcBFM8INKgPyATi-Wlz9_lAasGzLSq50PyMcEfu-DT04jG5ROY4D4DuVt7FK8rbAF9GV1cY5054Zct0MpONU9K55Y1UV4fnceFZ9OV59Pzsr1-YePJ8t1qWvcppIDadu8NtQqwTWl-QsEb1rcaKp0Y5TAUAtgTGhMTdViwwi0htsKjG3oUfF-zrofNz0YDUMKqpP74HoVbqRXTv4bGdxWXvlryZnguYGc4HhOsH0gO1uu5fSG82Bx29TXJLOv74oF_3WEmGTvooauUwP4McoJrFnF6qmvVw_QnR_DkAeRKVY1LefVRFUzpYOPMYC974BgOflBzn6Q2Q_y1g-SZdHLv798L_ltgAzQGYg5NFxB-FP7P2l_ATG9wt0</recordid><startdate>20201001</startdate><enddate>20201001</enddate><creator>Body, J.-J.</creator><creator>Marin, F.</creator><creator>Kendler, D.L.</creator><creator>Zerbini, C.A.F.</creator><creator>López-Romero, P.</creator><creator>Möricke, R.</creator><creator>Casado, E.</creator><creator>Fahrleitner-Pammer, A.</creator><creator>Stepan, J.J.</creator><creator>Lespessailles, E.</creator><creator>Minisola, S.</creator><creator>Geusens, P.</creator><general>Springer London</general><general>Springer Nature B.V</general><general>Springer Verlag</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>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><scope>7X8</scope><scope>1XC</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-7679-3965</orcidid><orcidid>https://orcid.org/0000-0001-6269-2354</orcidid><orcidid>https://orcid.org/0000-0001-6525-0439</orcidid><orcidid>https://orcid.org/0000-0002-9165-1444</orcidid><orcidid>https://orcid.org/0000-0001-8839-6430</orcidid><orcidid>https://orcid.org/0000-0003-2899-9840</orcidid><orcidid>https://orcid.org/0000-0001-8830-9974</orcidid><orcidid>https://orcid.org/0000-0002-7547-9146</orcidid><orcidid>https://orcid.org/0000-0001-9066-1109</orcidid><orcidid>https://orcid.org/0000-0003-1541-8306</orcidid><orcidid>https://orcid.org/0000-0002-5590-0888</orcidid><orcidid>https://orcid.org/0000-0003-1009-8518</orcidid></search><sort><creationdate>20201001</creationdate><title>Efficacy of teriparatide compared with risedronate on FRAX®-defined major osteoporotic fractures: results of the VERO clinical trial</title><author>Body, J.-J. ; Marin, F. ; Kendler, D.L. ; Zerbini, C.A.F. ; López-Romero, P. ; Möricke, R. ; Casado, E. ; Fahrleitner-Pammer, A. ; Stepan, J.J. ; Lespessailles, E. ; Minisola, S. ; Geusens, P.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c508t-7e188188b3fa97c3365010b806c3ac6da90e59e449c03d280d41e8d7f2edf63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Aged</topic><topic>Bisphosphonates</topic><topic>Bone Density</topic><topic>Bone Density Conservation Agents - therapeutic use</topic><topic>Clinical trials</topic><topic>Double-Blind Method</topic><topic>Endocrinology</topic><topic>Female</topic><topic>Forearm</topic><topic>Fractures</topic><topic>Human health and pathology</topic><topic>Humans</topic><topic>Humerus</topic><topic>Life Sciences</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Original</topic><topic>Original Article</topic><topic>Orthopedics</topic><topic>Osteoporosis</topic><topic>Osteoporosis, Postmenopausal - drug therapy</topic><topic>Osteoporotic Fractures - epidemiology</topic><topic>Osteoporotic Fractures - etiology</topic><topic>Osteoporotic Fractures - prevention & control</topic><topic>Parathyroid hormone</topic><topic>Patients</topic><topic>Post-menopause</topic><topic>Rheumatology</topic><topic>Rhumatology and musculoskeletal system</topic><topic>Risedronic acid</topic><topic>Risedronic Acid - therapeutic use</topic><topic>Risk assessment</topic><topic>Statistical analysis</topic><topic>Teriparatide - therapeutic use</topic><topic>Trauma</topic><topic>Vertebrae</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Body, J.-J.</creatorcontrib><creatorcontrib>Marin, F.</creatorcontrib><creatorcontrib>Kendler, D.L.</creatorcontrib><creatorcontrib>Zerbini, C.A.F.</creatorcontrib><creatorcontrib>López-Romero, P.</creatorcontrib><creatorcontrib>Möricke, R.</creatorcontrib><creatorcontrib>Casado, E.</creatorcontrib><creatorcontrib>Fahrleitner-Pammer, A.</creatorcontrib><creatorcontrib>Stepan, J.J.</creatorcontrib><creatorcontrib>Lespessailles, E.</creatorcontrib><creatorcontrib>Minisola, S.</creatorcontrib><creatorcontrib>Geusens, P.</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>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><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Osteoporosis international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Body, J.-J.</au><au>Marin, F.</au><au>Kendler, D.L.</au><au>Zerbini, C.A.F.</au><au>López-Romero, P.</au><au>Möricke, R.</au><au>Casado, E.</au><au>Fahrleitner-Pammer, A.</au><au>Stepan, J.J.</au><au>Lespessailles, E.</au><au>Minisola, S.</au><au>Geusens, P.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of teriparatide compared with risedronate on FRAX®-defined major osteoporotic fractures: results of the VERO clinical trial</atitle><jtitle>Osteoporosis international</jtitle><stitle>Osteoporos Int</stitle><addtitle>Osteoporos Int</addtitle><date>2020-10-01</date><risdate>2020</risdate><volume>31</volume><issue>10</issue><spage>1935</spage><epage>1942</epage><pages>1935-1942</pages><issn>0937-941X</issn><eissn>1433-2965</eissn><abstract>Summary
FRAX
®
calculates the 10-year probability of major osteoporotic fractures (MOF), which are considered to have a greater clinical impact than other fractures. Our results suggest that, in postmenopausal women with severe osteoporosis, those treated with teriparatide had a 60% lower risk of FRAX
®
-defined MOF compared with those treated with risedronate.
Introduction
The VERO trial was an active-controlled fracture endpoint clinical trial that enrolled postmenopausal women with severe osteoporosis. After 24 months, a 52% reduction in the hazard ratio (HR) of clinical fractures was reported in patients randomized to teriparatide compared with risedronate. We examined fracture results restricted to FRAX
®
-defined major osteoporotic fractures (MOF), which include clinical vertebral, hip, humerus, and forearm fractures.
Methods
In total, 1360 postmenopausal women (mean age 72.1 years) were randomized to receive subcutaneous daily teriparatide (20 μg) or oral weekly risedronate (35 mg). Patient cumulative incidence of ≥ 1 FRAX
®
-defined MOF and of all clinical fractures were estimated by Kaplan-Meier analyses, and the comparison between treatments was based on the stratified log-rank test. Additionally, an extended Cox model was used to estimate HRs at different time points. Incidence fracture rates were estimated at each 6-month interval.
Results
After 24 months, 16 (2.6%) patients in the teriparatide group had ≥ 1 low trauma FRAX
®
-defined MOF compared with 40 patients (6.4%) in the risedronate group (HR 0.40; 95% CI 0.23–0.68;
p
= 0.001). Clinical vertebral and radius fractures were the most frequent FRAX
®
-defined MOF sites. The largest difference in incidence rates of both FRAX
®
-defined MOF and all clinical fractures between treatments occurred during the 6- to 12-month period. There was a statistically significant reduction in fractures between groups as early as 7 months for both categories of clinical fractures analyzed.
Conclusion
In postmenopausal women with severe osteoporosis, treatment with teriparatide was more efficacious than risedronate, with a 60% lower risk of FRAX
®
-defined MOF during the 24-month treatment period. Fracture risk was statistically significantly reduced at 7 months of treatment.
Clinical trial information
ClinicalTrials.gov
Identifier: NCT01709110
EudraCT Number: 2012-000123-41</abstract><cop>London</cop><pub>Springer London</pub><pmid>32474650</pmid><doi>10.1007/s00198-020-05463-4</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0001-7679-3965</orcidid><orcidid>https://orcid.org/0000-0001-6269-2354</orcidid><orcidid>https://orcid.org/0000-0001-6525-0439</orcidid><orcidid>https://orcid.org/0000-0002-9165-1444</orcidid><orcidid>https://orcid.org/0000-0001-8839-6430</orcidid><orcidid>https://orcid.org/0000-0003-2899-9840</orcidid><orcidid>https://orcid.org/0000-0001-8830-9974</orcidid><orcidid>https://orcid.org/0000-0002-7547-9146</orcidid><orcidid>https://orcid.org/0000-0001-9066-1109</orcidid><orcidid>https://orcid.org/0000-0003-1541-8306</orcidid><orcidid>https://orcid.org/0000-0002-5590-0888</orcidid><orcidid>https://orcid.org/0000-0003-1009-8518</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0937-941X |
| ispartof | Osteoporosis international, 2020-10, Vol.31 (10), p.1935-1942 |
| issn | 0937-941X 1433-2965 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7497508 |
| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Aged Bisphosphonates Bone Density Bone Density Conservation Agents - therapeutic use Clinical trials Double-Blind Method Endocrinology Female Forearm Fractures Human health and pathology Humans Humerus Life Sciences Medicine Medicine & Public Health Original Original Article Orthopedics Osteoporosis Osteoporosis, Postmenopausal - drug therapy Osteoporotic Fractures - epidemiology Osteoporotic Fractures - etiology Osteoporotic Fractures - prevention & control Parathyroid hormone Patients Post-menopause Rheumatology Rhumatology and musculoskeletal system Risedronic acid Risedronic Acid - therapeutic use Risk assessment Statistical analysis Teriparatide - therapeutic use Trauma Vertebrae |
| title | Efficacy of teriparatide compared with risedronate on FRAX®-defined major osteoporotic fractures: results of the VERO clinical trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-02T02%3A49%3A45IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Efficacy%20of%20teriparatide%20compared%20with%20risedronate%20on%20FRAX%C2%AE-defined%20major%20osteoporotic%20fractures:%20results%20of%20the%20VERO%20clinical%20trial&rft.jtitle=Osteoporosis%20international&rft.au=Body,%20J.-J.&rft.date=2020-10-01&rft.volume=31&rft.issue=10&rft.spage=1935&rft.epage=1942&rft.pages=1935-1942&rft.issn=0937-941X&rft.eissn=1433-2965&rft_id=info:doi/10.1007/s00198-020-05463-4&rft_dat=%3Cproquest_pubme%3E2408542456%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2442687726&rft_id=info:pmid/32474650&rfr_iscdi=true |