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)

NCT04366726 | Completed Phase 1 Results FDA Drug FDA Device

• 1 other identifier: BA058-05-022
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.

Conditions

Postmenopausal Osteoporosis

Keywords

postmenopausal osteoporosis; transdermal delivery; microstructure patch; abaloparatide

Outcome Measures

Primary Outcomes (2)

• Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29

  0 (predose), 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours postdose on Day 29

• Abaloparatide Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) on Day 29

  0 (predose) and 4 hours postdose on Day 29

Secondary Outcomes (4)

• Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29

  Baseline, Day 29

• Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29

  Baseline, 0 (predose) and 4 hours postdose on Day 29

• Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29

  Baseline, 0 (predose) and 4 hours postdose on Day 29

• Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29

  Baseline, 0 (predose) and 30-minutes postdose on Day 29

Study Arms (1)

abaloparatide-sMTS

EXPERIMENTAL

Abaloparatide-sMTS 300 micrograms (μg) was applied to the thigh for 5 minutes once daily for 29 days.

Combination Product: abaloparatide-sMTS

Interventions

abaloparatide-sMTS COMBINATION_PRODUCT

Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto an sMTS array for transdermal administration of abaloparatide.

abaloparatide-sMTS

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal for at least 2 years
• 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)

You may not qualify if:

• History of prior external beam or implant radiation therapy involving the skeleton, other than radioiodine
• 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

Sponsors & Collaborators

• Radius Health, Inc.: lead

Study Sites (1)

Pharmaceutical Research Associates, Inc

Lenexa, Kansas, 66219, United States

Location

Related Publications (1)

• 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.

  PMID: 33638863 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Associate Director, Clinical Operations
• Organization: Radius Health, Inc.

info@radiuspharm.com

(617) 551-4000

Study Officials

• Medical Director

  Radius Health, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 29, 2020
• Study Start: April 9, 2019
• Primary Completion: May 14, 2019
• Study Completion: May 14, 2019
• Last Updated: November 22, 2023
• Results First Posted: November 22, 2023

Record last verified: 2023-02

Locations

US (1)