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Abaloparatide-SC improves trabecular microarchitecture as assessed by trabecular bone score (TBS): a 24-week randomized clinical trial.
Osteoporos Int. 2018 02; 29(2):323-328.OI

Abstract

In a phase 2 trial of 222 postmenopausal women with osteoporosis aged 55 to 85 years randomized to one of three different doses of abaloparatide-SC, subcutaneous teriparatide, or placebo for 24 weeks, abaloparatide-SC resulted in improvements in skeletal microarchitecture as measured by the trabecular bone score.

INTRODUCTION

Subcutaneous abaloparatide (abaloparatide-SC) increases total hip and lumbar spine bone mineral density and reduces vertebral and non-vertebral fractures. In this study, we analyzed the extent to which abaloparatide-SC improves skeletal microarchitecture, assessed indirectly by trabecular bone score (TBS).

METHODS

This is a post hoc analysis of a phase 2 trial of 222 postmenopausal women with osteoporosis aged 55 to 85 years randomized to abaloparatide-SC (20, 40, or 80 μg), subcutaneous teriparatide (20 μg), or placebo for 24 weeks. TBS was measured from lumbar spine dual X-ray absorptiometry (DXA) images in 138 women for whom the DXA device was TBS software compatible. Assessments were made at baseline, 12 and 24 weeks. Between-group differences were assessed by generalized estimating equations adjusted for relevant baseline characteristics, and a pre-determined least significant change analysis was performed.

RESULTS

After 24 weeks, TBS increased significantly by 2.27, 3.14, and 4.21% versus baseline in participants on 20, 40, and 80 μg abaloparatide-SC daily, respectively, and by 2.21% in those on teriparatide (p < 0.05 for each). The TBS in the placebo group declined by 1.08%. The TBS increase in each treatment group was significantly higher than placebo at 24 weeks (p < 0.0001 for each) after adjustment for age, BMI, and baseline TBS. A dose-response was observed at 24 weeks across the three doses of abaloparatide-SC and placebo (p = 0.02). The increase in TBS in the abaloparatide-SC 80 μg group was significantly greater than TPTD (p < 0.03).

CONCLUSIONS

These results are consistent with an effect of abaloparatide-SC to improve lumbar spine skeletal microarchitecture, as assessed by TBS.

Authors+Show Affiliations

Department of Endocrinology, Columbia University College of Physicians and Surgeons, New York, NY, USA.Radius Health, Inc., Waltham, MA, USA. ghattersley@radiuspharm.com.Radius Health, Inc., Waltham, MA, USA.Radius Health, Inc., Waltham, MA, USA.Center of Bone Diseases, Bone and Joint Department, Lausanne University Hospital, Lausanne, Switzerland.Radius Health, Inc., Waltham, MA, USA.Department of Medicine, Harvard Medical School, Endocrine Unit, Massachusetts General Hospital, Boston, MA, USA.Instituto de Investigaciones Metabólicas, Libertad, 836, Buenos Aires, Argentina.Center of Bone Diseases, Bone and Joint Department, Lausanne University Hospital, Lausanne, Switzerland.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29167971

Citation

Bilezikian, J P., et al. "Abaloparatide-SC Improves Trabecular Microarchitecture as Assessed By Trabecular Bone Score (TBS): a 24-week Randomized Clinical Trial." Osteoporosis International : a Journal Established as Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, vol. 29, no. 2, 2018, pp. 323-328.
Bilezikian JP, Hattersley G, Fitzpatrick LA, et al. Abaloparatide-SC improves trabecular microarchitecture as assessed by trabecular bone score (TBS): a 24-week randomized clinical trial. Osteoporos Int. 2018;29(2):323-328.
Bilezikian, J. P., Hattersley, G., Fitzpatrick, L. A., Harris, A. G., Shevroja, E., Banks, K., Leder, B. Z., Zanchetta, J. R., & Hans, D. (2018). Abaloparatide-SC improves trabecular microarchitecture as assessed by trabecular bone score (TBS): a 24-week randomized clinical trial. Osteoporosis International : a Journal Established as Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 29(2), 323-328. https://doi.org/10.1007/s00198-017-4304-9
Bilezikian JP, et al. Abaloparatide-SC Improves Trabecular Microarchitecture as Assessed By Trabecular Bone Score (TBS): a 24-week Randomized Clinical Trial. Osteoporos Int. 2018;29(2):323-328. PubMed PMID: 29167971.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Abaloparatide-SC improves trabecular microarchitecture as assessed by trabecular bone score (TBS): a 24-week randomized clinical trial. AU - Bilezikian,J P, AU - Hattersley,G, AU - Fitzpatrick,L A, AU - Harris,A G, AU - Shevroja,E, AU - Banks,K, AU - Leder,B Z, AU - Zanchetta,J R, AU - Hans,D, Y1 - 2017/11/22/ PY - 2017/07/11/received PY - 2017/11/06/accepted PY - 2017/11/24/pubmed PY - 2019/2/5/medline PY - 2017/11/24/entrez KW - Anabolics KW - Bone microarchitecture KW - Clinical trials KW - Osteoporosis SP - 323 EP - 328 JF - Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA JO - Osteoporos Int VL - 29 IS - 2 N2 - : In a phase 2 trial of 222 postmenopausal women with osteoporosis aged 55 to 85 years randomized to one of three different doses of abaloparatide-SC, subcutaneous teriparatide, or placebo for 24 weeks, abaloparatide-SC resulted in improvements in skeletal microarchitecture as measured by the trabecular bone score. INTRODUCTION: Subcutaneous abaloparatide (abaloparatide-SC) increases total hip and lumbar spine bone mineral density and reduces vertebral and non-vertebral fractures. In this study, we analyzed the extent to which abaloparatide-SC improves skeletal microarchitecture, assessed indirectly by trabecular bone score (TBS). METHODS: This is a post hoc analysis of a phase 2 trial of 222 postmenopausal women with osteoporosis aged 55 to 85 years randomized to abaloparatide-SC (20, 40, or 80 μg), subcutaneous teriparatide (20 μg), or placebo for 24 weeks. TBS was measured from lumbar spine dual X-ray absorptiometry (DXA) images in 138 women for whom the DXA device was TBS software compatible. Assessments were made at baseline, 12 and 24 weeks. Between-group differences were assessed by generalized estimating equations adjusted for relevant baseline characteristics, and a pre-determined least significant change analysis was performed. RESULTS: After 24 weeks, TBS increased significantly by 2.27, 3.14, and 4.21% versus baseline in participants on 20, 40, and 80 μg abaloparatide-SC daily, respectively, and by 2.21% in those on teriparatide (p < 0.05 for each). The TBS in the placebo group declined by 1.08%. The TBS increase in each treatment group was significantly higher than placebo at 24 weeks (p < 0.0001 for each) after adjustment for age, BMI, and baseline TBS. A dose-response was observed at 24 weeks across the three doses of abaloparatide-SC and placebo (p = 0.02). The increase in TBS in the abaloparatide-SC 80 μg group was significantly greater than TPTD (p < 0.03). CONCLUSIONS: These results are consistent with an effect of abaloparatide-SC to improve lumbar spine skeletal microarchitecture, as assessed by TBS. SN - 1433-2965 UR - https://www.unboundmedicine.com/medline/citation/29167971/Abaloparatide_SC_improves_trabecular_microarchitecture_as_assessed_by_trabecular_bone_score__TBS_:_a_24_week_randomized_clinical_trial_ L2 - https://doi.org/10.1007/s00198-017-4304-9 DB - PRIME DP - Unbound Medicine ER -