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Osteoporos Int. 2018 Feb;29(2):323-328. doi: 10.1007/s00198-017-4304-9. Epub 2017 Nov 22.

Abaloparatide-SC improves trabecular microarchitecture as assessed by trabecular bone score (TBS): a 24-week randomized clinical trial.

Author information

1
Department of Endocrinology, Columbia University College of Physicians and Surgeons, New York, NY, USA.
2
Radius Health, Inc., Waltham, MA, USA. ghattersley@radiuspharm.com.
3
Radius Health, Inc., Waltham, MA, USA.
4
Center of Bone Diseases, Bone and Joint Department, Lausanne University Hospital, Lausanne, Switzerland.
5
Department of Medicine, Harvard Medical School, Endocrine Unit, Massachusetts General Hospital, Boston, MA, USA.
6
Instituto de Investigaciones Metabólicas, Libertad, 836, Buenos Aires, Argentina.

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.

KEYWORDS:

Anabolics; Bone microarchitecture; Clinical trials; Osteoporosis

PMID:
29167971
PMCID:
PMC5818587
DOI:
10.1007/s00198-017-4304-9
[Indexed for MEDLINE]
Free PMC Article

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