Study · Randomized controlled trial · n = 2,463 · 2020

10 results

Cardiovascular Safety of Abaloparatide in Postmenopausal Women With Osteoporosis: Analysis From the ACTIVE Phase 3 Trial.

Cosman F, Peterson LR, Towler DA, Mitlak B, Wang Y, Cummings SR

The Journal of clinical endocrinology and metabolism1 Nov 2020Cited by 33 (Europe PMC)

PMID32658264PMCIDPMC7500469DOI10.1210/clinem/dgaa450PepBankPUB-32658264

Summary

ContextAbaloparatide is a US Food and Drug Administration-approved parathyroid hormone-related peptide analog for treatment of osteoporosis in postmenopausal women at high risk of fracture.ObjectivesWe assessed the cardiovascular safety profile of abaloparatide.DesignReview of heart rate (HR), blood pressure (BP), and cardiovascular-related adverse events (AEs), including major adverse cardiovascular events (MACEs) and heart failure (HF) from: (a) ACTIVE (NCT01343004), a phase 3 trial that randomized 2463 postmenopausal women with osteoporosis to abaloparatide, teriparatide, or placebo for 18 months; (b) ACTIVExtend (NCT01657162), where participants from the abaloparatide and placebo arms received alendronate for 2 years; and (c) a pharmacology study in 55 healthy adults.ResultsAbaloparatide and teriparatide transiently increased HR relative to placebo. Following first dose, mean (standard deviation [SD]) HR change from pretreatment to 1 hour posttreatment was 7.9 (8.5) beats per minute (bpm) for abaloparatide, 5.3 (7.5) for teriparatide, and 1.2 (7.1) for placebo. A similar pattern was observed over subsequent visits. In healthy volunteers, HR increase resolved within 4 hours. The corresponding change in mean supine systolic and diastolic BP 1 hour posttreatment was -2.7/-3.6 mmHg (abaloparatide), -2.0/-3.6 (teriparatide), and -1.5/-2.3 (placebo). The percentage of participants with serious cardiac AEs was similar among groups (0.9%-1.0%). In a post hoc analysis, time to first incidence of MACE + HF was longer with abaloparatide (P = 0.02 vs placebo) and teriparatide (P = 0.04 vs placebo).ConclusionsAbaloparatide was associated with transient increases in HR and small decreases in BP in postmenopausal women with osteoporosis, with no increase in risk of serious cardiac AEs, MACE, or HF.

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

Results from this study10

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialSafety outcome
In postmenopausal women with osteoporosis, serious cardiac adverse event proportions were similar across groups including abaloparatide.
In plain wordsIn women with osteoporosis, serious heart-related adverse events were similarly frequent across groups including abaloparatide.
Peptide
Abaloparatide (Tymlos)
Outcome
No significant changeSerious cardiac adverse events
Study
n = 2,463
Comparator
teriparatide and placebo groups
Outcome group
Adverse events · Cardiovascular
Studied dose
Dose not stated
Measurements
Participants with serious cardiac AEs
0.9 to 1%
across groups
Source sentences
Summary
The percentage of participants with serious cardiac AEs was similar among groups (0.9%-1.0%).
Show in the study text Report a problemFND-3265826406
02HumanRandomized controlled trialSafety outcome
In postmenopausal women with osteoporosis, abaloparatide increased heart rate versus placebo after the first dose.
In plain wordsIn women with osteoporosis, abaloparatide increased heart rate more than placebo after the first dose.
Peptide
Abaloparatide (Tymlos)
Outcome
IncreaseHeart rate after first dose
Study
n: not reported in source
Comparator
placebo
Outcome group
Heart function · Cardiovascular
Studied dose
Dose not stated
Measurements
Heart rate change
7.9 bpm
abaloparatide at 1 hour
Heart rate change
1.2 bpm
placebo at 1 hour
Source sentences
Summary
Following first dose, mean (standard deviation [SD]) HR change from pretreatment to 1 hour posttreatment was 7.9 (8.5) beats per minute (bpm) for abaloparatide, 5.3 (7.5) for teriparatide, and 1.2 (7.1) for placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
ACTIVE (NCT01343004), a phase 3 trial that randomized 2463 postmenopausal women with osteoporosis to abaloparatide, teriparatide, or placebo for 18 months;
Show in the study text Report a problemFND-3265826401
03HumanRandomized controlled trialSafety outcome
In postmenopausal women with osteoporosis, abaloparatide showed a similar transient heart rate increase pattern at subsequent visits versus placebo.
In plain wordsIn women with osteoporosis, abaloparatide showed a similar temporary heart rate increase pattern at later visits compared with placebo.
Peptide
Abaloparatide (Tymlos)
Outcome
IncreaseHeart rate at subsequent visits
Study
n: not reported in source
Comparator
placebo
Outcome group
Heart function · Cardiovascular
Studied dose
Dose not stated
Source sentences
Summary
A similar pattern was observed over subsequent visits.
1 context sentence(design, population, supporting numbers)
Summary · context
Abaloparatide and teriparatide transiently increased HR relative to placebo.
Show in the study text Report a problemFND-3265826402
04HumanRandomized controlled trialSafety outcome
In a post hoc analysis of women with osteoporosis, abaloparatide prolonged time to first MACE or heart failure versus placebo.
In plain wordsIn women with osteoporosis, abaloparatide delayed the first major cardiovascular event or heart failure versus placebo in a post hoc analysis.
Peptide
Abaloparatide (Tymlos)
Outcome
IncreaseTime to first MACE or heart failure
Study
n: not reported in source
Comparator
placebo
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
Dose not stated
Source sentences
Summary
In a post hoc analysis, time to first incidence of MACE + HF was longer with abaloparatide (P = 0.02 vs placebo) and teriparatide (P = 0.04 vs placebo).
Show in the study text Report a problemFND-3265826407
05HumanRandomized controlled trialSafety outcome
In women with osteoporosis, mean heart rate change 1 hour after the first dose was 7.9 bpm with abaloparatide and 5.3 bpm with teriparatide; the abstract reports no test of this difference.
In plain wordsIn women with osteoporosis, heart rate rose by 7.9 beats per minute with abaloparatide and 5.3 with teriparatide after the first dose.
Peptide
Abaloparatide (Tymlos)
Outcome
Direction not reportedHeart rate versus teriparatide
Study
n: not reported in source
Comparator
teriparatide
Outcome group
Heart function · Cardiovascular
Studied dose
Dose not stated
Measurements
Heart rate change
7.9 bpm
abaloparatide
Heart rate change
5.3 bpm
teriparatide
Source sentences
Summary
Following first dose, mean (standard deviation [SD]) HR change from pretreatment to 1 hour posttreatment was 7.9 (8.5) beats per minute (bpm) for abaloparatide, 5.3 (7.5) for teriparatide, and 1.2 (7.1) for placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
ACTIVE (NCT01343004), a phase 3 trial that randomized 2463 postmenopausal women with osteoporosis to abaloparatide, teriparatide, or placebo for 18 months;
Show in the study text Report a problemFND-3265826408
06HumanRandomized controlled trialSafety outcome
In women with osteoporosis, mean supine systolic pressure change 1 hour after treatment was -2.7 mmHg with abaloparatide and -2.0 mmHg with teriparatide; the abstract reports no test of this difference.
In plain wordsIn women with osteoporosis, systolic pressure fell by 2.7 mmHg with abaloparatide and 2.0 mmHg with teriparatide an hour after treatment.
Peptide
Abaloparatide (Tymlos)
Outcome
Direction not reportedSupine systolic blood pressure versus teriparatide
Study
n: not reported in source
Comparator
teriparatide
Outcome group
Blood pressure · Cardiovascular
Studied dose
Dose not stated
Measurements
Systolic pressure change
−2.7 mmHg
abaloparatide
Systolic pressure change
−2 mmHg
teriparatide
Source sentences
Summary
The corresponding change in mean supine systolic and diastolic BP 1 hour posttreatment was -2.7/-3.6 mmHg (abaloparatide), -2.0/-3.6 (teriparatide), and -1.5/-2.3 (placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
ACTIVE (NCT01343004), a phase 3 trial that randomized 2463 postmenopausal women with osteoporosis to abaloparatide, teriparatide, or placebo for 18 months;
Show in the study text Report a problemFND-3265826409
07HumanRandomized controlled trialSafety outcome
In women with osteoporosis, mean supine diastolic pressure changes were equal with abaloparatide and teriparatide one hour after treatment.
In plain wordsIn women with osteoporosis, average diastolic pressure changes were equal with abaloparatide and teriparatide one hour after treatment.
Peptide
Abaloparatide (Tymlos)
Outcome
No significant changeSupine diastolic blood pressure versus teriparatide
Study
n: not reported in source
Comparator
teriparatide
Outcome group
Blood pressure · Cardiovascular
Studied dose
Dose not stated
Measurements
Diastolic pressure change
−3.6 mmHg
abaloparatide
Diastolic pressure change
−3.6 mmHg
teriparatide
Source sentences
Summary
The corresponding change in mean supine systolic and diastolic BP 1 hour posttreatment was -2.7/-3.6 mmHg (abaloparatide), -2.0/-3.6 (teriparatide), and -1.5/-2.3 (placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
ACTIVE (NCT01343004), a phase 3 trial that randomized 2463 postmenopausal women with osteoporosis to abaloparatide, teriparatide, or placebo for 18 months;
Show in the study text Report a problemFND-3265826410
08HumanOther designSafety outcome
In healthy volunteers, the heart rate increase after abaloparatide resolved within 4 hours.
In plain wordsIn healthy volunteers, the heart rate increase after abaloparatide resolved within 4 hours.
Peptide
Abaloparatide (Tymlos)
Outcome
Not applicableHeart rate recovery in healthy volunteers
Study
n = 55
Outcome group
Heart function · Cardiovascular
Studied dose
Dose not stated
Measurements
Time to heart rate increase resolution
≤ 4 hours
healthy volunteers
Source sentences
Summary
In healthy volunteers, HR increase resolved within 4 hours.
1 context sentence(design, population, supporting numbers)
Summary · context
(c) a pharmacology study in 55 healthy adults.
Show in the study text Report a problemFND-3265826403

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).

09HumanNot a test of Abaloparatide (Tymlos) aloneRandomized controlled trialSafety outcome
In postmenopausal women with osteoporosis, mean supine systolic blood pressure fell 1 hour after treatment in all groups: -2.7 mmHg with abaloparatide and -1.5 mmHg with placebo.
In plain wordsIn women with osteoporosis, systolic blood pressure fell in all groups an hour after treatment, including the placebo group.
Peptide
Abaloparatide (Tymlos)
Outcome
Direction not reportedSupine systolic blood pressure
Study
n: not reported in source
Comparator
placebo
Outcome group
Blood pressure · Cardiovascular
Measurements
Systolic blood pressure change
−2.7 mmHg
abaloparatide
Systolic blood pressure change
−1.5 mmHg
placebo
Source sentences
Summary
The corresponding change in mean supine systolic and diastolic BP 1 hour posttreatment was -2.7/-3.6 mmHg (abaloparatide), -2.0/-3.6 (teriparatide), and -1.5/-2.3 (placebo).
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-3265826404
10HumanNot a test of Abaloparatide (Tymlos) aloneRandomized controlled trialSafety outcome
In postmenopausal women with osteoporosis, mean supine diastolic blood pressure fell 1 hour after treatment in all groups: -3.6 mmHg with abaloparatide and -2.3 mmHg with placebo.
In plain wordsIn women with osteoporosis, diastolic blood pressure fell in all groups an hour after treatment, including the placebo group.
Peptide
Abaloparatide (Tymlos)
Outcome
Direction not reportedSupine diastolic blood pressure
Study
n: not reported in source
Comparator
placebo
Outcome group
Blood pressure · Cardiovascular
Measurements
Diastolic blood pressure change
−3.6 mmHg
abaloparatide
Diastolic blood pressure change
−2.3 mmHg
placebo
Source sentences
Summary
The corresponding change in mean supine systolic and diastolic BP 1 hour posttreatment was -2.7/-3.6 mmHg (abaloparatide), -2.0/-3.6 (teriparatide), and -1.5/-2.3 (placebo).
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-3265826405

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

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