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Study · Non-randomized trial · n = 22 · 2021

13 results

Phase 1b Evaluation of Abaloparatide Solid Microstructured Transdermal System (Abaloparatide-sMTS) in Postmenopausal Women with Low Bone Mineral Density.

Miller PD, Troy S, Weiss RJ, Annett M, Schense J, Williams SA, Mitlak B

Clinical drug investigation27 Feb 2021Cited by 19 (Europe PMC)

PMID33638863 (opens in a new tab)PMCIDPMC7946681 (opens in a new tab)DOI10.1007/s40261-021-01008-7 (opens in a new tab)PepBankPUB-33638863
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

  1. 01HumanNon-randomized trialPharmacokinetics

    In postmenopausal women with low BMD, abaloparatide-sMTS had a median Tmax of 0.33 h on Day 1.

    In plain wordsIn women with low bone density, median time to peak blood concentration after abaloparatide-sMTS was 0.33 h on Day 1.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableDay 1 Tmax
    Study

    n = 22

    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    300 μg once daily · intradermal · 29 daysAs given in this study (human).

    Measurements

    Tmax
    0.33 h
    Day 1

    Source sentences

    Summary
    On Day 1, the median time to reach maximum concentration (Tmax) for abaloparatide-sMTS was 0.33 h
    1 context sentence
    Summary · context
    In this single-arm, open-label, Phase 1b study, 22 healthy postmenopausal women aged 50-85 years with low BMD were trained to self-administer abaloparatide-sMTS 300 μg once daily to the thigh for 5 min for 29 days.
  2. 02HumanNon-randomized trialPharmacokinetics

    In postmenopausal women with low BMD, abaloparatide-sMTS geometric mean Cmax was 447 pg/mL on Day 1.

    In plain wordsIn women with low bone density, abaloparatide-sMTS had a geometric mean peak blood concentration of 447 pg/mL.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableDay 1 Cmax
    Study

    n = 22

    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    300 μg once daily · intradermal · 29 daysAs given in this study (human).

    Measurements

    Cmax
    447 pg/mL
    Day 1
    Cmax CV
    38%
    Day 1

    Source sentences

    Summary
    and geometric mean (CV %) maximum concentration (Cmax) and area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) were 447 (38.0) pg/mL and 678 (45.3) pg·h/mL, respectively
    1 context sentence
    Summary · context
    In this single-arm, open-label, Phase 1b study, 22 healthy postmenopausal women aged 50-85 years with low BMD were trained to self-administer abaloparatide-sMTS 300 μg once daily to the thigh for 5 min for 29 days.
  3. 03HumanNon-randomized trialPharmacokinetics

    In postmenopausal women with low BMD, abaloparatide-sMTS geometric mean AUC0-t was 678 pg·h/mL on Day 1.

    In plain wordsIn women with low bone density, abaloparatide-sMTS had a geometric mean blood exposure of 678 pg·h/mL.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableDay 1 AUC0-t
    Study

    n = 22

    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    300 μg once daily · intradermal · 29 daysAs given in this study (human).

    Measurements

    AUC0-t
    678 pg·h/mL
    Day 1
    AUC0-t CV
    45.3%
    Day 1

    Source sentences

    Summary
    and geometric mean (CV %) maximum concentration (Cmax) and area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) were 447 (38.0) pg/mL and 678 (45.3) pg·h/mL, respectively
    1 context sentence
    Summary · context
    In this single-arm, open-label, Phase 1b study, 22 healthy postmenopausal women aged 50-85 years with low BMD were trained to self-administer abaloparatide-sMTS 300 μg once daily to the thigh for 5 min for 29 days.
  4. 04HumanNon-randomized trialPharmacokinetics

    In women with low BMD, the abaloparatide-sMTS pharmacokinetic profile was similar on Days 15 and 29 to Day 1.

    In plain wordsIn women with low bone density, abaloparatide-sMTS blood exposure profiles were similar to Day 1 on Days 15 and 29.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    No significant changePK profile over repeat administration
    Study

    n = 22

    Comparator
    Day 1
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    300 μg once daily · intradermal · 29 daysAs given in this study (human).

    Source sentences

    Summary
    the pharmacokinetic profile was similar on Days 15 and 29.
    1 context sentence
    Summary · context
    In this single-arm, open-label, Phase 1b study, 22 healthy postmenopausal women aged 50-85 years with low BMD were trained to self-administer abaloparatide-sMTS 300 μg once daily to the thigh for 5 min for 29 days.
  5. 05HumanNon-randomized trialEfficacy outcome

    In women with low BMD, median s-PINP increased 45.4% from baseline at Day 15 with abaloparatide-sMTS.

    In plain wordsIn women with low bone density, abaloparatide-sMTS increased median s-PINP by 45.4% from baseline at Day 15.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseDay 15 s-PINP change
    Study

    n = 22

    Comparator
    Baseline
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    300 μg once daily · intradermal · 29 daysAs given in this study (human).

    Measurements

    s-PINP change
    45.4%
    Day 15

    Source sentences

    Summary
    Median percentage change in s-PINP was 45.4% and 64.4% at Days 15 and 29, respectively.
    1 context sentence
    Summary · context
    In this single-arm, open-label, Phase 1b study, 22 healthy postmenopausal women aged 50-85 years with low BMD were trained to self-administer abaloparatide-sMTS 300 μg once daily to the thigh for 5 min for 29 days.
  6. 06HumanNon-randomized trialEfficacy outcome

    In women with low BMD, median s-PINP increased 64.4% from baseline at Day 29 with abaloparatide-sMTS.

    In plain wordsIn women with low bone density, abaloparatide-sMTS increased median s-PINP by 64.4% from baseline at Day 29.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseDay 29 s-PINP change
    Study

    n = 22

    Comparator
    Baseline
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    300 μg once daily · intradermal · 29 daysAs given in this study (human).

    Measurements

    s-PINP change
    64.4%
    Day 29

    Source sentences

    Summary
    Median percentage change in s-PINP was 45.4% and 64.4% at Days 15 and 29, respectively.
    1 context sentence
    Summary · context
    In this single-arm, open-label, Phase 1b study, 22 healthy postmenopausal women aged 50-85 years with low BMD were trained to self-administer abaloparatide-sMTS 300 μg once daily to the thigh for 5 min for 29 days.
  7. 07HumanNon-randomized trialSafety outcome

    In women with low BMD, application site erythema was a common abaloparatide-sMTS adverse event, mostly mild or moderate.

    In plain wordsIn women with low bone density, skin redness was a common abaloparatide-sMTS side effect, mostly mild or moderate.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableApplication site erythema
    Study

    n = 22

    Analysis
    Secondary
    Outcome group
    Adverse events · Skin and wound
    Studied dose
    300 μg once daily · intradermal · 29 daysAs given in this study (human).

    Source sentences

    Summary
    The most common adverse events (AEs) were application site erythema, pain, and swelling, which were mostly of mild or moderate severity.
    1 context sentence
    Summary · context
    In this single-arm, open-label, Phase 1b study, 22 healthy postmenopausal women aged 50-85 years with low BMD were trained to self-administer abaloparatide-sMTS 300 μg once daily to the thigh for 5 min for 29 days.
  8. 08HumanNon-randomized trialSafety outcome

    In women with low BMD, application site pain was a common abaloparatide-sMTS adverse event, mostly mild or moderate.

    In plain wordsIn women with low bone density, application site pain was a common abaloparatide-sMTS side effect, mostly mild or moderate.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableApplication site pain
    Study

    n = 22

    Analysis
    Secondary
    Outcome group
    Adverse events · Skin and wound
    Studied dose
    300 μg once daily · intradermal · 29 daysAs given in this study (human).

    Source sentences

    Summary
    The most common adverse events (AEs) were application site erythema, pain, and swelling, which were mostly of mild or moderate severity.
    1 context sentence
    Summary · context
    In this single-arm, open-label, Phase 1b study, 22 healthy postmenopausal women aged 50-85 years with low BMD were trained to self-administer abaloparatide-sMTS 300 μg once daily to the thigh for 5 min for 29 days.
  9. 09HumanNon-randomized trialSafety outcome

    In women with low BMD, application site swelling was a common abaloparatide-sMTS adverse event, mostly mild or moderate.

    In plain wordsIn women with low bone density, application site swelling was a common abaloparatide-sMTS side effect, mostly mild or moderate.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableApplication site swelling
    Study

    n = 22

    Analysis
    Secondary
    Outcome group
    Adverse events · Skin and wound
    Studied dose
    300 μg once daily · intradermal · 29 daysAs given in this study (human).

    Source sentences

    Summary
    The most common adverse events (AEs) were application site erythema, pain, and swelling, which were mostly of mild or moderate severity.
    1 context sentence
    Summary · context
    In this single-arm, open-label, Phase 1b study, 22 healthy postmenopausal women aged 50-85 years with low BMD were trained to self-administer abaloparatide-sMTS 300 μg once daily to the thigh for 5 min for 29 days.
  10. 10HumanNon-randomized trialSafety outcome

    In women with low BMD, no adverse events caused abaloparatide-sMTS withdrawal.

    In plain wordsIn women with low bone density, no side effects caused withdrawal of abaloparatide-sMTS.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableAdverse-event withdrawals
    Study

    n = 22

    Analysis
    Secondary
    Outcome group
    Adverse events · Whole body
    Studied dose
    300 μg once daily · intradermal · 29 daysAs given in this study (human).

    Source sentences

    Summary
    No AEs led to study drug withdrawal and no serious AEs were reported.
    1 context sentence
    Summary · context
    In this single-arm, open-label, Phase 1b study, 22 healthy postmenopausal women aged 50-85 years with low BMD were trained to self-administer abaloparatide-sMTS 300 μg once daily to the thigh for 5 min for 29 days.
  11. 11HumanNon-randomized trialSafety outcome

    In women with low BMD, no serious adverse events were reported during abaloparatide-sMTS treatment.

    In plain wordsIn women with low bone density, no serious side effects were reported during abaloparatide-sMTS treatment.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableSerious adverse events
    Study

    n = 22

    Analysis
    Secondary
    Outcome group
    Adverse events · Whole body
    Studied dose
    300 μg once daily · intradermal · 29 daysAs given in this study (human).

    Source sentences

    Summary
    No AEs led to study drug withdrawal and no serious AEs were reported.
    1 context sentence
    Summary · context
    In this single-arm, open-label, Phase 1b study, 22 healthy postmenopausal women aged 50-85 years with low BMD were trained to self-administer abaloparatide-sMTS 300 μg once daily to the thigh for 5 min for 29 days.
  12. 12HumanNon-randomized trialOther

    In women with low BMD, first-application self-administration success for abaloparatide-sMTS was 99.7%.

    In plain wordsIn women with low bone density, first-application self-administration success for abaloparatide-sMTS was 99.7%.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableSelf-administration success
    Study

    n = 22

    Analysis
    Secondary
    Outcome group
    Device usability · Pharmacology
    Studied dose
    300 μg once daily · intradermal · 29 daysAs given in this study (human).

    Measurements

    Success rate
    99.7%
    first application

    Source sentences

    Summary
    The success rate for self-administration at first application was 99.7%, and subject acceptability was high (~ 4.5 on a 5-point Likert Scale).
    1 context sentence
    Summary · context
    In this single-arm, open-label, Phase 1b study, 22 healthy postmenopausal women aged 50-85 years with low BMD were trained to self-administer abaloparatide-sMTS 300 μg once daily to the thigh for 5 min for 29 days.
  13. 13HumanNon-randomized trialOther

    In women with low BMD, abaloparatide-sMTS acceptability was approximately 4.5 on a 5-point Likert scale.

    In plain wordsIn women with low bone density, abaloparatide-sMTS acceptability was approximately 4.5 on a 5-point scale.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableSubject acceptability
    Study

    n = 22

    Analysis
    Secondary
    Outcome group
    Patient-reported outcomes · Pharmacology
    Studied dose
    300 μg once daily · intradermal · 29 daysAs given in this study (human).

    Measurements

    Acceptability
    ≈ 4.5 points
    5-point Likert scale

    Source sentences

    Summary
    The success rate for self-administration at first application was 99.7%, and subject acceptability was high (~ 4.5 on a 5-point Likert Scale).
    1 context sentence
    Summary · context
    In this single-arm, open-label, Phase 1b study, 22 healthy postmenopausal women aged 50-85 years with low BMD were trained to self-administer abaloparatide-sMTS 300 μg once daily to the thigh for 5 min for 29 days.

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 1Results postedNCT04366726

Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD)

Radius Health, Inc.n = 229 Apr 2019 to 14 May 2019

Postmenopausal Osteoporosis

Trial pageClinicalTrials.govUpdated 22 Nov 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.

  1. Version 2Current

    22 Oct 2026, 02:25 UTC

    Study results updated

  2. 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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