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)
NCT ID: NCT04366726
Last Updated: 2023-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2019-04-09
2019-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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abaloparatide-sMTS
Abaloparatide-sMTS 300 micrograms (μg) was applied to the thigh for 5 minutes once daily for 29 days.
abaloparatide-sMTS
Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto an sMTS array for transdermal administration of abaloparatide.
Interventions
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abaloparatide-sMTS
Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto an sMTS array for transdermal administration of abaloparatide.
Eligibility Criteria
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Inclusion Criteria
* BMD T-score based on the female reference range \<-1.0 and \>-5.0 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (DXA)
* Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index up to 33 kilograms/square meter (kg/m\^2)
* Laboratory tests within the normal range including serum calcium (albumin-corrected), intact parathyroid hormone (PTH), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone
* Serum 25-hydroxyvitamin D values ≥ 20 nanograms per milliliter (ng/mL)
Exclusion Criteria
* History of bone disorders other than postmenopausal osteoporosis (such as Paget's disease)
* History of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)
* History of Cushing's disease, hypo or hyperparathyroidism, or malabsorptive syndromes within the past year
* Prior treatment with PTH, PTH-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or PTH (1-84)
* Prior treatment with intravenous bisphosphonates at any time or oral bisphosphonates within the past year (12 months). Participants who have received a short course of oral bisphosphonate therapy (3 months or less) may be enrolled as long as the treatment occurred 6 or more months prior to enrollment
* Prior treatment with an investigational drug or device within the past 3 months or 5 half-lives of the investigational drug, whichever is longer
50 Years
85 Years
FEMALE
No
Sponsors
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Radius Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Radius Health, Inc.
Locations
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Pharmaceutical Research Associates, Inc
Lenexa, Kansas, United States
Countries
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References
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Miller PD, Troy S, Weiss RJ, Annett M, Schense J, Williams SA, Mitlak B. Phase 1b Evaluation of Abaloparatide Solid Microstructured Transdermal System (Abaloparatide-sMTS) in Postmenopausal Women with Low Bone Mineral Density. Clin Drug Investig. 2021 Mar;41(3):277-285. doi: 10.1007/s40261-021-01008-7. Epub 2021 Feb 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BA058-05-022
Identifier Type: -
Identifier Source: org_study_id