Effects of abaloparatide-SC (BA058) on bone histology and histomorphometry

The ACTIVE phase 3 trial

Carolina A. Moreira, Lorraine A. Fitzpatrick, Yamei Wang, Robert R. Recker

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

There are a number of effective treatments for osteoporosis but most are in the antiresorptive class of compounds. Abaloparatide-SC is a new osteoanabolic agent, which increased bone mineral density and lowered the risk of osteoporosis-related fractures in the phase 3 ACTIVE trial. The objective of this report is to describe the effects of abaloparatide-SC 80 μg on bone histology and histomorphometry in iliac crest bone biopsies from this trial in which participants were randomized to receive blinded daily subcutaneous injections of placebo or abaloparatide-SC 80 μg/d or open-label teriparatide 20 μg/d for 18 months. Iliac crest bone biopsies were obtained between 12 and 18 months. Qualitative histological analysis of biopsies from abaloparatide-SC-treated patients revealed normal bone microarchitecture without evidence of adverse effects on mineralization or on the formation of normal lamellar bone. There were no bone marrow abnormalities, marrow fibrosis nor was there presence of excess osteoid or woven bone. There were few significant differences among the three treatment groups in a standard panel of static and dynamic histomorphometric indices. The mineral apposition rate was higher in the teriparatide-treated group than in the placebo-treated group. The eroded surface was lower in the abaloparatide-SC-treated group than in the placebo-treated group. Cortical porosity was higher in both the abaloparatide-SC- and the teriparatide-treated groups than in the placebo-treated group. We conclude that histological and histomorphometric analysis of iliac crest bone biopsies from subjects who were treated for up to 18 months with abaloparatide-SC showed no evidence of concern for bone safety. Trial registration: ClinicalTrials.gov number NCT01343004.

Original languageEnglish (US)
Pages (from-to)314-319
Number of pages6
JournalBone
Volume97
DOIs
StatePublished - Apr 1 2017

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Histology
Bone and Bones
Teriparatide
Placebos
Biopsy
Osteoporosis
Bone Marrow
abaloparatide
Porosity
Subcutaneous Injections
Bone Density
Minerals
Fibrosis
Safety
Therapeutics

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism
  • Histology
  • Physiology

Cite this

Effects of abaloparatide-SC (BA058) on bone histology and histomorphometry : The ACTIVE phase 3 trial. / Moreira, Carolina A.; Fitzpatrick, Lorraine A.; Wang, Yamei; Recker, Robert R.

In: Bone, Vol. 97, 01.04.2017, p. 314-319.

Research output: Contribution to journalArticle

Moreira, Carolina A. ; Fitzpatrick, Lorraine A. ; Wang, Yamei ; Recker, Robert R. / Effects of abaloparatide-SC (BA058) on bone histology and histomorphometry : The ACTIVE phase 3 trial. In: Bone. 2017 ; Vol. 97. pp. 314-319.
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