Efficacy and Safety of Transdermal Abaloparatide in Postmenopausal Women with Osteoporosis: A Randomized Study.

Lewiecki EM, Czerwinski E, Recknor C, Strzelecka A, Valenzuela G, Lawrence M, Silverman S, Cardona J, Nattrass SM, Binkley N, Annett M, Pearman L, Mitlak B

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research27 Jul 2023Cited by 18 (Europe PMC)

PMID37417725DOI10.1002/jbmr.4877PepBankPUB-37417725

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Summary

Anabolic therapies, recommended for patients at very high fracture risk, are administered subcutaneously (SC). The objective of this study was to evaluate the efficacy and safety of the abaloparatide microstructured transdermal system (abaloparatide-sMTS) as an alternative to the SC formulation. This phase 3, noninferiority study (NCT04064411) randomly assigned postmenopausal women with osteoporosis (N = 511) 1:1 to open-label abaloparatide administered daily via abaloparatide-sMTS or SC injection for 12 months. The primary comparison between treatment groups was the percentage change in lumbar spine bone mineral density (BMD) at 12 months, with a noninferiority margin of 2.0%. Secondary endpoints included percentage change in total hip and femoral neck BMD, bone turnover markers, dermatologic safety, and new clinical fracture incidence. At 12 months, percentage increase from baseline in lumbar spine BMD was 7.14% (SE: 0.46%) for abaloparatide-sMTS and 10.86% (SE: 0.48%) for abaloparatide-SC (treatment difference: -3.72% [95% confidence interval: -5.01%, -2.43%]). Percentage change in total hip BMD was 1.97% for abaloparatide-sMTS and 3.70% for abaloparatide-SC. Median changes from baseline at 12 months in serum procollagen type I N-terminal propeptide (s-PINP) were 52.6% for abaloparatide-sMTS and 74.5% for abaloparatide-SC. Administration site reactions were the most frequently reported adverse events (abaloparatide-sMTS, 94.4%; abaloparatide-SC, 70.5%). Incidence of serious adverse events was similar between groups. Mild or moderate skin reactions occurred with abaloparatide-sMTS with no identifiable risk factors for sensitization reactions. Few new clinical fractures occurred in either group. Noninferiority of abaloparatide-sMTS to abaloparatide-SC for percentage change in spine BMD at 12 months was not demonstrated; however, clinically meaningful increases from baseline in lumbar spine and total hip BMD were observed in both treatment groups. © 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 study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In postmenopausal women with osteoporosis, transdermal abaloparatide produced a smaller spine BMD increase than subcutaneous abaloparatide and did not demonstrate noninferiority.
In plain wordsIn women with osteoporosis, transdermal abaloparatide increased spine bone density less than injected abaloparatide.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseLumbar spine BMD
Study
n = 511
Comparator
Subcutaneous abaloparatide
Analysis
Primary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · microstructured transdermal system · 12 monthsAs given in this study (human).
Measurements
Lumbar spine BMD change
7.14%
transdermal
Lumbar spine BMD change
10.86%
subcutaneous
Treatment difference
−3.72%
transdermal versus subcutaneous
95% CI
−5.01 to −2.43%
treatment difference
SE of lumbar spine BMD change
0.46%
transdermal
SE of lumbar spine BMD change
0.48%
subcutaneous
Source sentences
Summary
At 12 months, percentage increase from baseline in lumbar spine BMD was 7.14% (SE: 0.46%) for abaloparatide-sMTS and 10.86% (SE: 0.48%) for abaloparatide-SC (treatment difference: -3.72% [95% confidence interval: -5.01%, -2.43%]).
3 context sentences(design, population, supporting numbers)
Summary · context
Noninferiority of abaloparatide-sMTS to abaloparatide-SC for percentage change in spine BMD at 12 months was not demonstrated; however, clinically meaningful increases from baseline in lumbar spine and total hip BMD were observed in both treatment groups. © 2023 Radius Health, Inc and The Authors.
Summary · context
The primary comparison between treatment groups was the percentage change in lumbar spine bone mineral density (BMD) at 12 months, with a noninferiority margin of 2.0%.
Summary · context
This phase 3, noninferiority study (NCT04064411) randomly assigned postmenopausal women with osteoporosis (N = 511) 1:1 to open-label abaloparatide administered daily via abaloparatide-sMTS or SC injection for 12 months.
Show in the study text Report a problemFND-3741772501
02HumanRandomized controlled trialEfficacy outcome
In postmenopausal women with osteoporosis, total hip BMD increased less with transdermal than subcutaneous abaloparatide.
In plain wordsIn women with osteoporosis, transdermal abaloparatide increased hip bone density less than injected abaloparatide.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseTotal hip BMD
Study
n = 511
Comparator
Subcutaneous abaloparatide
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · microstructured transdermal system · 12 monthsAs given in this study (human).
Measurements
Total hip BMD change
1.97%
transdermal
Total hip BMD change
3.7%
subcutaneous
Source sentences
Summary
Percentage change in total hip BMD was 1.97% for abaloparatide-sMTS and 3.70% for abaloparatide-SC.
2 context sentences(design, population, supporting numbers)
Summary · context
Secondary endpoints included percentage change in total hip and femoral neck BMD, bone turnover markers, dermatologic safety, and new clinical fracture incidence.
Summary · context
This phase 3, noninferiority study (NCT04064411) randomly assigned postmenopausal women with osteoporosis (N = 511) 1:1 to open-label abaloparatide administered daily via abaloparatide-sMTS or SC injection for 12 months.
Show in the study text Report a problemFND-3741772502
03HumanRandomized controlled trialEfficacy outcome
In postmenopausal women with osteoporosis, median serum PINP increases were smaller with transdermal than subcutaneous abaloparatide.
In plain wordsIn women with osteoporosis, transdermal abaloparatide increased a bone formation marker less than injected abaloparatide.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseSerum PINP
Study
n = 511
Comparator
Subcutaneous abaloparatide
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · microstructured transdermal system · 12 monthsAs given in this study (human).
Measurements
Median serum PINP change
52.6%
transdermal
Median serum PINP change
74.5%
subcutaneous
Source sentences
Summary
Median changes from baseline at 12 months in serum procollagen type I N-terminal propeptide (s-PINP) were 52.6% for abaloparatide-sMTS and 74.5% for abaloparatide-SC.
2 context sentences(design, population, supporting numbers)
Summary · context
Secondary endpoints included percentage change in total hip and femoral neck BMD, bone turnover markers, dermatologic safety, and new clinical fracture incidence.
Summary · context
This phase 3, noninferiority study (NCT04064411) randomly assigned postmenopausal women with osteoporosis (N = 511) 1:1 to open-label abaloparatide administered daily via abaloparatide-sMTS or SC injection for 12 months.
Show in the study text Report a problemFND-3741772503
04HumanRandomized controlled trialSafety outcome
In postmenopausal women with osteoporosis, few new clinical fractures occurred with either transdermal or subcutaneous abaloparatide.
In plain wordsIn women with osteoporosis, few new fractures occurred with either transdermal or injected abaloparatide.
Peptide
Abaloparatide (Tymlos)
Outcome
Direction not reportedNew clinical fractures
Study
n = 511
Comparator
Subcutaneous abaloparatide
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · microstructured transdermal system · 12 monthsAs given in this study (human).
Source sentences
Summary
Few new clinical fractures occurred in either group.
2 context sentences(design, population, supporting numbers)
Summary · context
Secondary endpoints included percentage change in total hip and femoral neck BMD, bone turnover markers, dermatologic safety, and new clinical fracture incidence.
Summary · context
This phase 3, noninferiority study (NCT04064411) randomly assigned postmenopausal women with osteoporosis (N = 511) 1:1 to open-label abaloparatide administered daily via abaloparatide-sMTS or SC injection for 12 months.
Show in the study text Report a problemFND-3741772508
05HumanRandomized controlled trialSafety outcome
In postmenopausal women with osteoporosis, mild or moderate skin reactions occurred with transdermal abaloparatide.
In plain wordsIn women with osteoporosis, mild or moderate skin reactions occurred with transdermal abaloparatide.
Peptide
Abaloparatide (Tymlos)
Outcome
Not applicableSkin reaction severity
Study
n: not reported in source
Analysis
Secondary
Outcome group
Adverse events · Skin and wound
Studied dose
Dose not stated · microstructured transdermal system · 12 monthsAs given in this study (human).
Source sentences
Summary
Mild or moderate skin reactions occurred with abaloparatide-sMTS with no identifiable risk factors for sensitization reactions.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, noninferiority study (NCT04064411) randomly assigned postmenopausal women with osteoporosis (N = 511) 1:1 to open-label abaloparatide administered daily via abaloparatide-sMTS or SC injection for 12 months.
Show in the study text Report a problemFND-3741772506
06HumanRandomized controlled trialSafety outcome
In postmenopausal women with osteoporosis, administration site reactions occurred more often with transdermal than subcutaneous abaloparatide.
In plain wordsIn women with osteoporosis, application-site reactions occurred more often with transdermal than injected abaloparatide.
Peptide
Abaloparatide (Tymlos)
Outcome
IncreaseAdministration site reactions
Study
n = 511
Comparator
Subcutaneous abaloparatide
Outcome group
Adverse events · Skin and wound
Studied dose
Dose not stated · microstructured transdermal system · 12 monthsAs given in this study (human).
Measurements
Administration site reactions
94.4%
transdermal
Administration site reactions
70.5%
subcutaneous
Source sentences
Summary
Administration site reactions were the most frequently reported adverse events (abaloparatide-sMTS, 94.4%; abaloparatide-SC, 70.5%).
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, noninferiority study (NCT04064411) randomly assigned postmenopausal women with osteoporosis (N = 511) 1:1 to open-label abaloparatide administered daily via abaloparatide-sMTS or SC injection for 12 months.
Show in the study text Report a problemFND-3741772504
07HumanRandomized controlled trialSafety outcome
In postmenopausal women with osteoporosis, serious adverse event incidence was similar with transdermal and subcutaneous abaloparatide.
In plain wordsIn women with osteoporosis, serious adverse events occurred at similar rates with transdermal and injected abaloparatide.
Peptide
Abaloparatide (Tymlos)
Outcome
No significant changeSerious adverse events
Study
n = 511
Comparator
Subcutaneous abaloparatide
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · microstructured transdermal system · 12 monthsAs given in this study (human).
Source sentences
Summary
Incidence of serious adverse events was similar between groups.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, noninferiority study (NCT04064411) randomly assigned postmenopausal women with osteoporosis (N = 511) 1:1 to open-label abaloparatide administered daily via abaloparatide-sMTS or SC injection for 12 months.
Show in the study text Report a problemFND-3741772505

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 postedNCT04064411

Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis

Radius Health, Inc.n = 5115 Aug 2019 to 9 Nov 2021

Postmenopausal Osteoporosis

Trial page ClinicalTrials.govUpdated 15 Feb 2023

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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