Efficacy and Safety of Transdermal Abaloparatide in Postmenopausal Women with Osteoporosis : A Randomized Study
© 2023 Radius Health, Inc and The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR)..
Anabolic therapies, recommended for patients at very high fracture risk, are administered subcutaneously (SC). The objective of this study was to evaluate the efficacy and safety of the abaloparatide microstructured transdermal system (abaloparatide-sMTS) as an alternative to the SC formulation. This phase 3, noninferiority study (NCT04064411) randomly assigned postmenopausal women with osteoporosis (N = 511) 1:1 to open-label abaloparatide administered daily via abaloparatide-sMTS or SC injection for 12 months. The primary comparison between treatment groups was the percentage change in lumbar spine bone mineral density (BMD) at 12 months, with a noninferiority margin of 2.0%. Secondary endpoints included percentage change in total hip and femoral neck BMD, bone turnover markers, dermatologic safety, and new clinical fracture incidence. At 12 months, percentage increase from baseline in lumbar spine BMD was 7.14% (SE: 0.46%) for abaloparatide-sMTS and 10.86% (SE: 0.48%) for abaloparatide-SC (treatment difference: -3.72% [95% confidence interval: -5.01%, -2.43%]). Percentage change in total hip BMD was 1.97% for abaloparatide-sMTS and 3.70% for abaloparatide-SC. Median changes from baseline at 12 months in serum procollagen type I N-terminal propeptide (s-PINP) were 52.6% for abaloparatide-sMTS and 74.5% for abaloparatide-SC. Administration site reactions were the most frequently reported adverse events (abaloparatide-sMTS, 94.4%; abaloparatide-SC, 70.5%). Incidence of serious adverse events was similar between groups. Mild or moderate skin reactions occurred with abaloparatide-sMTS with no identifiable risk factors for sensitization reactions. Few new clinical fractures occurred in either group. Noninferiority of abaloparatide-sMTS to abaloparatide-SC for percentage change in spine BMD at 12 months was not demonstrated; however, clinically meaningful increases from baseline in lumbar spine and total hip BMD were observed in both treatment groups. © 2023 Radius Health, Inc and The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:38 |
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| Enthalten in: |
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research - 38(2023), 10 vom: 06. Okt., Seite 1404-1414 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lewiecki, E Michael [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 23.10.2023 Date Revised 26.10.2023 published: Print-Electronic ClinicalTrials.gov: NCT04064411 Citation Status MEDLINE |
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| doi: |
10.1002/jbmr.4877 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Lewiecki, E Michael |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and Safety of Transdermal Abaloparatide in Postmenopausal Women with Osteoporosis |b A Randomized Study |
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| 500 | |a Date Revised 26.10.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04064411 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 Radius Health, Inc and The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR). | ||
| 520 | |a Anabolic therapies, recommended for patients at very high fracture risk, are administered subcutaneously (SC). The objective of this study was to evaluate the efficacy and safety of the abaloparatide microstructured transdermal system (abaloparatide-sMTS) as an alternative to the SC formulation. This phase 3, noninferiority study (NCT04064411) randomly assigned postmenopausal women with osteoporosis (N = 511) 1:1 to open-label abaloparatide administered daily via abaloparatide-sMTS or SC injection for 12 months. The primary comparison between treatment groups was the percentage change in lumbar spine bone mineral density (BMD) at 12 months, with a noninferiority margin of 2.0%. Secondary endpoints included percentage change in total hip and femoral neck BMD, bone turnover markers, dermatologic safety, and new clinical fracture incidence. At 12 months, percentage increase from baseline in lumbar spine BMD was 7.14% (SE: 0.46%) for abaloparatide-sMTS and 10.86% (SE: 0.48%) for abaloparatide-SC (treatment difference: -3.72% [95% confidence interval: -5.01%, -2.43%]). Percentage change in total hip BMD was 1.97% for abaloparatide-sMTS and 3.70% for abaloparatide-SC. Median changes from baseline at 12 months in serum procollagen type I N-terminal propeptide (s-PINP) were 52.6% for abaloparatide-sMTS and 74.5% for abaloparatide-SC. Administration site reactions were the most frequently reported adverse events (abaloparatide-sMTS, 94.4%; abaloparatide-SC, 70.5%). Incidence of serious adverse events was similar between groups. Mild or moderate skin reactions occurred with abaloparatide-sMTS with no identifiable risk factors for sensitization reactions. Few new clinical fractures occurred in either group. Noninferiority of abaloparatide-sMTS to abaloparatide-SC for percentage change in spine BMD at 12 months was not demonstrated; however, clinically meaningful increases from baseline in lumbar spine and total hip BMD were observed in both treatment groups. © 2023 Radius Health, Inc and The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR) | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a ABALOPARATIDE-sMTS | |
| 650 | 4 | |a BONE MINERAL DENSITY | |
| 650 | 4 | |a BONE TURNOVER MARKERS | |
| 650 | 4 | |a FRACTURE | |
| 650 | 4 | |a OSTEOPOROSIS | |
| 650 | 4 | |a TRANSDERMAL | |
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| 650 | 7 | |a AVK0I6HY2U |2 NLM | |
| 650 | 7 | |a Bone Density Conservation Agents |2 NLM | |
| 650 | 7 | |a Procollagen Type I |2 NLM | |
| 650 | 7 | |a Minerals |2 NLM | |
| 700 | 1 | |a Czerwinski, Edward |e verfasserin |4 aut | |
| 700 | 1 | |a Recknor, Chris |e verfasserin |4 aut | |
| 700 | 1 | |a Strzelecka, Anna |e verfasserin |4 aut | |
| 700 | 1 | |a Valenzuela, Guillermo |e verfasserin |4 aut | |
| 700 | 1 | |a Lawrence, Mary |e verfasserin |4 aut | |
| 700 | 1 | |a Silverman, Stuart |e verfasserin |4 aut | |
| 700 | 1 | |a Cardona, Jose |e verfasserin |4 aut | |
| 700 | 1 | |a Nattrass, Susan M |e verfasserin |4 aut | |
| 700 | 1 | |a Binkley, Neil |e verfasserin |4 aut | |
| 700 | 1 | |a Annett, Miriam |e verfasserin |4 aut | |
| 700 | 1 | |a Pearman, Leny |e verfasserin |4 aut | |
| 700 | 1 | |a Mitlak, Bruce |e verfasserin |4 aut | |
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