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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT04064411 (opens ClinicalTrials.gov in a new tab)Other idBA058-05-021
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
511 participants (actual)
Sponsor
Radius Health, Inc. · Industry
Design
Randomized · Single masking
Countries
5 countries

United States, Denmark, Hungary, Poland, Puerto Rico

Start
5 Aug 2019
Primary completion
5 Oct 2021
Completion
9 Nov 2021
First posted
21 Aug 2019
Last update posted
15 Feb 2023
Conditions
Postmenopausal Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph 3

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

    NCT04064411

    5 Aug 2019 to 9 Nov 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured transdermal system (sMTS) with abaloparatide-subcutaneous (SC).

Interventions

  • abaloparatideCombination product
  • abaloparatide solid microstructured transdermal systemCombination product

Arms2

  • Active comparator

    abaloparatide-SC

    Participants self-administered daily doses of abaloparatide 80 mcg SC for 12 months using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.

  • Experimental

    abaloparatide-sMTS

    Abaloparatide-sMTS 300 mcg applied to the thigh for 5 minutes once daily for 12 months.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change From Baseline in Lumbar Spine BMD at Month 12

    Time frame · Baseline, Month 12

    Registry description

    Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory.

Secondary outcomes(2)

  1. Percent Change From Baseline in Total Hip BMD at Month 12

    Time frame · Baseline, Month 12

    Registry description

    Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory.

  2. Percent Change From Baseline in Femoral Neck BMD at Month 12

    Time frame · Baseline, Month 12

    Registry description

    Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Month 12

Percent Change From Baseline in Lumbar Spine BMD at Month 12

GroupValue (percent change)Spread
Abaloparatide-SC10.85710.4755
Abaloparatide-sMTS7.13610.4605
Secondary and other outcome results(2)
Secondary outcomeLeast squares mean· Baseline, Month 12

Percent Change From Baseline in Total Hip BMD at Month 12

GroupValue (percent change)Spread
Abaloparatide-SC3.69950.2776
Abaloparatide-sMTS1.96880.2675
Secondary outcomeLeast squares mean· Baseline, Month 12

Percent Change From Baseline in Femoral Neck BMD at Month 12

GroupValue (percent change)Spread
Abaloparatide-SC3.41590.3750
Abaloparatide-sMTS1.91630.3599

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Abaloparatide-SCParticipants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen.1 / 25419 / 254204 / 254
Abaloparatide-sMTSParticipants self-administered daily doses of abaloparatide-sMTS 300 mcg.0 / 25216 / 252239 / 252

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

7 results

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

Lewiecki et al. 2023Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 18

PMID 37417725DOI 10.1002/jbmr.4877PUB-37417725

Full text at the publisher7 results
Publisher pageSee results (7)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 50 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy ambulatory female from 50 to 85 years of age (inclusive) with postmenopausal osteoporosis * Participants who are 50 to 65 years old with BMD T-score ≤ -2.5 and \> -5.0 at the lumbar spine or hip (femoral neck or total hip) by dual energy x-ray absorptiometry (DXA) and meet one of the following: 1) radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures or 2) history of fragility fracture to the forearm, humerus, sacrum, pelvis, hip, femur, or tibia within the past 5 years. * Participants older than 65 years with BMD T score ≤ -2.0 and \> -5.0 who meet the fracture criteria may be enrolled * Participants older than 65 years with BMD T score ≤ -3.0 and \> -5.0 at the lumbar spine or hip (femoral neck or total hip) by DXA * Body mass index of 18.5 to 33 kilograms (kg)/square meters (m\^2), inclusive * serum calcium (albumin-corrected), parathyroid hormone (1-84), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone within the normal reference range * Serum 25-hydroxyvitamin D values must be ≥ 20 nanograms (ng)/milliliters (mL) Exclusion Criteria: * History of more than 4 mild or moderate spine fractures or any severe fracture * Abnormality of the spine or hip that would prohibit assessment of BMD * History of bone disorders other than postmenopausal osteoporosis or a diagnosis of cancer within the last 5 years * History of Cushing's disease, thyroid, parathyroid, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient * Prior treatment with parathyroid hormone, parathyroid hormone-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or parathyroid hormone (1-84) * Prior treatment with intravenous (IV) bisphosphonates at any time or oral bisphosphonates within the past 3 years; fluoride or strontium within the past 5 years; treatment with corticosteroids within the past 12 months; or selective estrogen receptor modulators within the past 6 months (except hormone replacement therapy) * Prior treatment with an investigational drug or device within the past 90 days or 5 half-lives of the investigational drug, whichever is longer * History of nephrolithiasis or urolithiasis within the past 5 years or hereditary disorders predisposing to osteosarcoma

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