Study · Randomized controlled trial · n = 911 · 2023

6 results

Effect of Abaloparatide on Bone Microarchitecture Assessed by Trabecular Bone Score in Women With Osteoporosis: Post Hoc Analysis of ACTIVE and ACTIVExtend.

Cosman F, Hans D, Shevroja E, Wang Y, Mitlak B

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research12 Feb 2023Cited by 5 (Europe PMC)

PMID36588166DOI10.1002/jbmr.4764PepBankPUB-36588166

Publisher page PubMedAsk about this study

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Summary

Although bone mineral density (BMD) is a predictor of fracture, many fractures occur in women with T-scores > -2.5. Bone microarchitecture, assessed by trabecular bone score (TBS), predicts fracture risk independent of BMD. We evaluated whether abaloparatide improves TBS and whether TBS trends were associated with vertebral fracture risk reduction. Women with osteoporosis randomized to abaloparatide or placebo for 18 months (ACTIVE), followed by alendronate for 24 months (ACTIVExtend), with evaluable TBS, were included in this post hoc analysis (N = 911). TBS was calculated from spine BMD scans using an algorithm adjusted for tissue thickness (TBS_th ) at baseline, 6, 18, and 43 months. Mean increments in TBS_th from baseline within and between treatment groups, proportion of women with TBS_th increments above least significant change (LSC) and proportion with degraded TBS_th (th . Mean TBS_th increased 4% after 18 months abaloparatide (p < 0.001) and was unchanged with placebo. After 2 subsequent years of alendronate, the total cumulative TBS_th increase was 4.4% with abaloparatide/alendronate and 1.7% with placebo/alendronate (group difference, p < 0.001). At 43 months, the proportion of women with degraded TBS_th had declined to 21% with abaloparatide/alendronate and 37% with placebo/alendronate (p < 0.05). An increase in TBS_th ≥ LSC was observed in 50% of abaloparatide-treated women at 18 months and was associated with decreased odds (odds ratio [OR]; 95% confidence interval [CI]) of vertebral fracture (0.19; 95% CI, 0.04-0.80, 6 months; 0.30; 95% CI, 0.11-0.79, 43 months). In conclusion, abaloparatide increased TBS_th rapidly and progressively over 18 months and increments were maintained over 2 years with alendronate. TBS_th increase was associated with vertebral fracture risk reduction. Microarchitectural improvement may be one mechanism by which abaloparatide strengthens vertebral bone. © 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).

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

Results from this study6

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In women with osteoporosis, mean tissue-thickness-adjusted TBS increased 4% after abaloparatide and remained unchanged with placebo.
In plain wordsIn women with osteoporosis, bone scores increased 4% with abaloparatide and remained unchanged with placebo.
Peptide
Abaloparatide (Tymlos)
Outcome
IncreaseTBS change at 18 months
Study
n = 911
Comparator
placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · 18 monthsAs given in this study (human).
Measurements
Mean TBS change from baseline
4%
abaloparatide, 18 months
Source sentences
Summary
Mean TBS_th increased 4% after 18 months abaloparatide (p < 0.001) and was unchanged with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
Women with osteoporosis randomized to abaloparatide or placebo for 18 months (ACTIVE), followed by alendronate for 24 months (ACTIVExtend), with evaluable TBS, were included in this post hoc analysis (N = 911).
Show in the study text Report a problemFND-3658816602
02HumanRandomized controlled trialEfficacy outcome
In women with osteoporosis, cumulative TBS increased 4.4% after abaloparatide/alendronate versus 1.7% after placebo/alendronate.
In plain wordsIn women, bone scores increased more after abaloparatide then alendronate than after placebo then alendronate.
Peptide
Abaloparatide (Tymlos)
Outcome
IncreaseCumulative TBS change
Study
n = 911
Comparator
placebo followed by alendronate
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated
Measurements
Cumulative TBS increase
4.4%
abaloparatide/alendronate
Cumulative TBS increase
1.7%
placebo/alendronate
Source sentences
Summary
After 2 subsequent years of alendronate, the total cumulative TBS_th increase was 4.4% with abaloparatide/alendronate and 1.7% with placebo/alendronate (group difference, p < 0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
Women with osteoporosis randomized to abaloparatide or placebo for 18 months (ACTIVE), followed by alendronate for 24 months (ACTIVExtend), with evaluable TBS, were included in this post hoc analysis (N = 911).
Show in the study text Report a problemFND-3658816603
03HumanRandomized controlled trialEfficacy outcome
At 43 months, degraded TBS occurred in 21% after abaloparatide/alendronate versus 37% after placebo/alendronate.
In plain wordsIn women, degraded bone scores were less frequent after abaloparatide then alendronate than after placebo then alendronate.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseDegraded TBS at 43 months
Study
n = 911
Comparator
placebo followed by alendronate
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated
Measurements
Proportion with degraded TBS at 43 months
21%
abaloparatide/alendronate
Proportion with degraded TBS at 43 months
37%
placebo/alendronate
Source sentences
Summary
At 43 months, the proportion of women with degraded TBS_th had declined to 21% with abaloparatide/alendronate and 37% with placebo/alendronate (p < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
Women with osteoporosis randomized to abaloparatide or placebo for 18 months (ACTIVE), followed by alendronate for 24 months (ACTIVExtend), with evaluable TBS, were included in this post hoc analysis (N = 911).
Show in the study text Report a problemFND-3658816604
04HumanRandomized controlled trialEfficacy outcome
In women receiving abaloparatide, 50% had TBS increases at least as large as the least significant change at 18 months.
In plain wordsIn women receiving abaloparatide, 50% had bone score increases at least as large as the least significant change.
Peptide
Abaloparatide (Tymlos)
Outcome
Not applicableTBS improvement above LSC
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · 18 monthsAs given in this study (human).
Measurements
Proportion with TBS increase >= LSC
50%
abaloparatide-treated women, 18 months
Source sentences
Summary
An increase in TBS_th ≥ LSC was observed in 50% of abaloparatide-treated women at 18 months
1 context sentence(design, population, supporting numbers)
Summary · context
Women with osteoporosis randomized to abaloparatide or placebo for 18 months (ACTIVE), followed by alendronate for 24 months (ACTIVExtend), with evaluable TBS, were included in this post hoc analysis (N = 911).
Show in the study text Report a problemFND-3658816605

Studies that did not test the peptide alone2

In this study, Abaloparatide (Tymlos) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Abaloparatide (Tymlos).

05HumanNot a test of Abaloparatide (Tymlos) aloneObservational studyEfficacy outcome
In the post hoc osteoporosis analysis, TBS increases at least equal to LSC were associated with lower vertebral fracture odds at 6 months (OR 0.19).
In plain wordsIn women, bone score increases at least equal to the threshold were linked to lower vertebral fracture odds at 6 months.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseTBS improvement and vertebral fracture odds at 6 months
Study
n: not reported in source
Comparator
women without TBS increase ≥ LSC
Outcome group
Bone and joint · Musculoskeletal
Measurements
Odds ratio for vertebral fracture
0.19 OR
TBS increase >= LSC, 6 months
95% CI of odds ratio
0.04 to 0.8 OR
TBS increase >= LSC, 6 months
Source sentences
Summary
An increase in TBS_th ≥ LSC was observed in 50% of abaloparatide-treated women at 18 months and was associated with decreased odds (odds ratio [OR]; 95% confidence interval [CI]) of vertebral fracture (0.19; 95% CI, 0.04-0.80, 6 months; 0.30; 95% CI, 0.11-0.79, 43 months).
1 context sentence(design, population, supporting numbers)
Summary · context
Women with osteoporosis randomized to abaloparatide or placebo for 18 months (ACTIVE), followed by alendronate for 24 months (ACTIVExtend), with evaluable TBS, were included in this post hoc analysis (N = 911).
In this study, Abaloparatide (Tymlos) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Abaloparatide (Tymlos).
Show in the study text Report a problemFND-3658816606
06HumanNot a test of Abaloparatide (Tymlos) aloneObservational studyEfficacy outcome
In the post hoc osteoporosis analysis, TBS increases at least equal to LSC were associated with lower vertebral fracture odds at 43 months (OR 0.30).
In plain wordsIn women, bone score increases at least equal to the threshold were linked to lower vertebral fracture odds at 43 months.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseTBS improvement and vertebral fracture odds at 43 months
Study
n: not reported in source
Comparator
women without TBS increase ≥ LSC
Outcome group
Bone and joint · Musculoskeletal
Measurements
Odds ratio for vertebral fracture
0.3 OR
TBS increase >= LSC, 43 months
95% CI of odds ratio
0.11 to 0.79 OR
TBS increase >= LSC, 43 months
Source sentences
Summary
An increase in TBS_th ≥ LSC was observed in 50% of abaloparatide-treated women at 18 months and was associated with decreased odds (odds ratio [OR]; 95% confidence interval [CI]) of vertebral fracture (0.19; 95% CI, 0.04-0.80, 6 months; 0.30; 95% CI, 0.11-0.79, 43 months).
1 context sentence(design, population, supporting numbers)
Summary · context
Women with osteoporosis randomized to abaloparatide or placebo for 18 months (ACTIVE), followed by alendronate for 24 months (ACTIVExtend), with evaluable TBS, were included in this post hoc analysis (N = 911).
In this study, Abaloparatide (Tymlos) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Abaloparatide (Tymlos).
Show in the study text Report a problemFND-3658816607

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

Registered trials2

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

2 trials · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01657162

Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis

Radius Health, Inc.n = 1,13920 Nov 2012 to 3 Oct 2016

Postmenopausal Osteoporosis

Trial page ClinicalTrials.govUpdated 11 Dec 2020

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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