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)

Postmenopausal Osteoporosis Clinical Trial

Official title:

A Prospective, Single Arm Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Usability of Abaloparatide-sMTS in Postmenopausal Women With Low Bone Mineral Density

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366726
• Other study ID #: BA058-05-022
• Status: Completed
• Phase: Phase 1
• Start date: April 9, 2019
• Est. completion date: May 14, 2019

Study information

• Verified date: February 2023
• Source: Radius Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study aimed to evaluate the ability of participants to self-administer 300 μg abaloparatide-sMTS over a period of 29 days based on PK and PD markers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 14, 2019
• Est. primary completion date: May 14, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
United States	Pharmaceutical Research Associates, Inc	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Radius Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29	Blood samples were taken to measure s-PINP, a bone formation marker. s-PINP concentrations reflect the rate of skeletal new bone formation. Increases in s-PINP indicate anabolic biologic response in the bone.	Baseline, Day 29
Secondary	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
Secondary	Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29		Baseline, 0 (predose) and 4 hours postdose on Day 29
Secondary	Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29		Baseline, 0 (predose) and 30-minutes postdose on Day 29