Effects of abaloparatide-SC (BA058) on bone histology and histomorphometry: The ACTIVE phase 3 trial.

Moreira CA, Fitzpatrick LA, Wang Y, Recker RR

Bone5 Nov 2016Cited by 57 (Europe PMC)

PMID27826127DOI10.1016/j.bone.2016.11.004PepBankPUB-27826127

Publisher page PubMedAsk about this study

Summary

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 80μg 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 80μg/d or open-label teriparatide 20μg/d for 18months. Iliac crest bone biopsies were obtained between 12 and 18months. 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 18months with abaloparatide-SC showed no evidence of concern for bone safety.Trial registrationClinicalTrials.gov number NCT01343004.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialSafety outcome
In osteoporosis trial biopsies, abaloparatide-treated patients showed normal bone microarchitecture.
In plain wordsBone biopsies from abaloparatide-treated patients showed normal structure.
Peptide
Abaloparatide (Tymlos)
Outcome
Not applicableBone microarchitecture
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
80μg/d · subcutaneous · 18 monthsAs given in this study (human).
Source sentences
Summary
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.
2 context sentences(design, population, supporting numbers)
Summary · context
in which participants were randomized to receive blinded daily subcutaneous injections of placebo or abaloparatide-SC 80μg/d or open-label teriparatide 20μg/d for 18months.
Summary · context
Iliac crest bone biopsies were obtained between 12 and 18months.
Show in the study text Report a problemFND-2782612701
02HumanRandomized controlled trialSafety outcome
In osteoporosis trial biopsies, abaloparatide showed no evidence of adverse effects on mineralization.
In plain wordsBone biopsies from abaloparatide-treated patients showed no adverse effects on mineralization.
Peptide
Abaloparatide (Tymlos)
Outcome
No significant changeAdverse mineralization effects
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
80μg/d · subcutaneous · 18 monthsAs given in this study (human).
Source sentences
Summary
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.
2 context sentences(design, population, supporting numbers)
Summary · context
in which participants were randomized to receive blinded daily subcutaneous injections of placebo or abaloparatide-SC 80μg/d or open-label teriparatide 20μg/d for 18months.
Summary · context
Iliac crest bone biopsies were obtained between 12 and 18months.
Show in the study text Report a problemFND-2782612702
03HumanRandomized controlled trialSafety outcome
In osteoporosis trial biopsies, abaloparatide showed no evidence of adverse effects on normal lamellar bone formation.
In plain wordsBone biopsies from abaloparatide-treated patients showed no adverse effects on normal layered bone formation.
Peptide
Abaloparatide (Tymlos)
Outcome
No significant changeNormal lamellar bone formation
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
80μg/d · subcutaneous · 18 monthsAs given in this study (human).
Source sentences
Summary
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.
2 context sentences(design, population, supporting numbers)
Summary · context
in which participants were randomized to receive blinded daily subcutaneous injections of placebo or abaloparatide-SC 80μg/d or open-label teriparatide 20μg/d for 18months.
Summary · context
Iliac crest bone biopsies were obtained between 12 and 18months.
Show in the study text Report a problemFND-2782612703
04HumanRandomized controlled trialSafety outcome
In abaloparatide-treated patients, bone biopsies showed no bone marrow abnormalities.
In plain wordsBone biopsies from abaloparatide-treated patients showed no marrow abnormalities.
Peptide
Abaloparatide (Tymlos)
Outcome
No significant changeBone marrow abnormalities
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
80μg/d · subcutaneous · 18 monthsAs given in this study (human).
Source sentences
Summary
There were no bone marrow abnormalities, marrow fibrosis nor was there presence of excess osteoid or woven bone.
3 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
in which participants were randomized to receive blinded daily subcutaneous injections of placebo or abaloparatide-SC 80μg/d or open-label teriparatide 20μg/d for 18months.
Summary · context
Iliac crest bone biopsies were obtained between 12 and 18months.
Show in the study text Report a problemFND-2782612704
05HumanRandomized controlled trialSafety outcome
In abaloparatide-treated patients, bone biopsies showed no marrow fibrosis.
In plain wordsBone biopsies from abaloparatide-treated patients showed no marrow fibrosis.
Peptide
Abaloparatide (Tymlos)
Outcome
No significant changeMarrow fibrosis
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
80μg/d · subcutaneous · 18 monthsAs given in this study (human).
Source sentences
Summary
There were no bone marrow abnormalities, marrow fibrosis nor was there presence of excess osteoid or woven bone.
3 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
in which participants were randomized to receive blinded daily subcutaneous injections of placebo or abaloparatide-SC 80μg/d or open-label teriparatide 20μg/d for 18months.
Summary · context
Iliac crest bone biopsies were obtained between 12 and 18months.
Show in the study text Report a problemFND-2782612705
06HumanRandomized controlled trialSafety outcome
In abaloparatide-treated patients, bone biopsies showed no excess osteoid.
In plain wordsBone biopsies from abaloparatide-treated patients showed no excess unmineralized bone tissue.
Peptide
Abaloparatide (Tymlos)
Outcome
No significant changeExcess osteoid
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
80μg/d · subcutaneous · 18 monthsAs given in this study (human).
Source sentences
Summary
There were no bone marrow abnormalities, marrow fibrosis nor was there presence of excess osteoid or woven bone.
3 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
in which participants were randomized to receive blinded daily subcutaneous injections of placebo or abaloparatide-SC 80μg/d or open-label teriparatide 20μg/d for 18months.
Summary · context
Iliac crest bone biopsies were obtained between 12 and 18months.
Show in the study text Report a problemFND-2782612706
07HumanRandomized controlled trialSafety outcome
In abaloparatide-treated patients, bone biopsies showed no woven bone.
In plain wordsBone biopsies from abaloparatide-treated patients showed no woven bone.
Peptide
Abaloparatide (Tymlos)
Outcome
No significant changeWoven bone
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
80μg/d · subcutaneous · 18 monthsAs given in this study (human).
Source sentences
Summary
There were no bone marrow abnormalities, marrow fibrosis nor was there presence of excess osteoid or woven bone.
3 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
in which participants were randomized to receive blinded daily subcutaneous injections of placebo or abaloparatide-SC 80μg/d or open-label teriparatide 20μg/d for 18months.
Summary · context
Iliac crest bone biopsies were obtained between 12 and 18months.
Show in the study text Report a problemFND-2782612707
08HumanRandomized controlled trialEfficacy outcome
In osteoporosis trial biopsies, few histomorphometric indices differed significantly among abaloparatide, placebo and teriparatide groups.
In plain wordsBone biopsy measurements showed few significant differences among abaloparatide, placebo and teriparatide groups.
Peptide
Abaloparatide (Tymlos)
Outcome
MixedStatic and dynamic histomorphometric panel
Study
n: not reported in source
Comparator
placebo and teriparatide
Outcome group
Bone and joint · Musculoskeletal
Studied dose
80μg/d · subcutaneous · 18 monthsAs given in this study (human).
Source sentences
Summary
There were few significant differences among the three treatment groups in a standard panel of static and dynamic histomorphometric indices.
2 context sentences(design, population, supporting numbers)
Summary · context
in which participants were randomized to receive blinded daily subcutaneous injections of placebo or abaloparatide-SC 80μg/d or open-label teriparatide 20μg/d for 18months.
Summary · context
Iliac crest bone biopsies were obtained between 12 and 18months.
Show in the study text Report a problemFND-2782612708
09HumanRandomized controlled trialEfficacy outcome
In osteoporosis trial biopsies, eroded surface was lower with abaloparatide than placebo.
In plain wordsBone biopsies showed less eroded surface with abaloparatide than placebo.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseEroded surface
Study
n: not reported in source
Comparator
placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
80μg/d · subcutaneous · 18 monthsAs given in this study (human).
Source sentences
Summary
The eroded surface was lower in the abaloparatide-SC-treated group than in the placebo-treated group.
2 context sentences(design, population, supporting numbers)
Summary · context
in which participants were randomized to receive blinded daily subcutaneous injections of placebo or abaloparatide-SC 80μg/d or open-label teriparatide 20μg/d for 18months.
Summary · context
Iliac crest bone biopsies were obtained between 12 and 18months.
Show in the study text Report a problemFND-2782612709
10HumanRandomized controlled trialSafety outcome
In osteoporosis trial biopsies, cortical porosity was higher with abaloparatide than placebo.
In plain wordsBone biopsies showed greater cortical porosity with abaloparatide than placebo.
Peptide
Abaloparatide (Tymlos)
Outcome
IncreaseCortical porosity
Study
n: not reported in source
Comparator
placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
80μg/d · subcutaneous · 18 monthsAs given in this study (human).
Source sentences
Summary
Cortical porosity was higher in both the abaloparatide-SC- and the teriparatide-treated groups than in the placebo-treated group.
2 context sentences(design, population, supporting numbers)
Summary · context
in which participants were randomized to receive blinded daily subcutaneous injections of placebo or abaloparatide-SC 80μg/d or open-label teriparatide 20μg/d for 18months.
Summary · context
Iliac crest bone biopsies were obtained between 12 and 18months.
Show in the study text Report a problemFND-2782612710

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01343004

Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

Radius Health, Inc.n = 2,463Apr 2011 to Oct 2014

Osteoporosis · Postmenopausal Osteoporosis

Trial page ClinicalTrials.govUpdated 1 Mar 2017

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:25 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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