Trial · Interventional

CompletedPhase 1Results postedRegistry data

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)

NCTNCT04366726Other idBA058-05-022

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 22 participants (actual)
Sponsor: Radius Health, Inc. · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 9 Apr 2019
Primary completion: 14 May 2019
Completion: 14 May 2019
First posted: 29 Apr 2020
Last update posted: 22 Nov 2023
Conditions: Postmenopausal Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20192020

Ph 1
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
9 Apr 2019 to 14 May 2019

Registry summary

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

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

Interventions

abaloparatide-sMTSCombination product

Arms1

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

Primary outcomes2

Outcomes the sponsor listed as primary.

Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29
Time frame · 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
Time frame · 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
Time frame · Baseline, Day 29
Registry description
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.
Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29
Time frame · Baseline, 0 (predose) and 4 hours postdose on Day 29
Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29
Time frame · Baseline, 0 (predose) and 4 hours postdose on Day 29
Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29
Time frame · Baseline, 0 (predose) and 30-minutes postdose on Day 29

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 outcomeGeometric mean· 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 Maximum Plasma Concentration (Cmax) on Day 29

Group	Value (picograms/milliliter (pg/mL))	Spread
Abaloparatide-sMTS	399.6	41.8

Primary outcomeGeometric mean· 0 (predose) 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

Group	Value (hour*pg/mL)	Spread
Abaloparatide-sMTS	604.7	51.1

Secondary and other outcome results(4)

Secondary outcomeMean· Baseline, Day 29

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

Group	Value (percent change)	Spread
Abaloparatide-sMTS	103.16	104.729

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

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

Group	Value (millimoles/liter (mmol/L))	Spread
Abaloparatide-sMTS	-0.031	0.0986

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

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

Group	Value (mmol/L)	Spread
Abaloparatide-sMTS	0.051	0.1832

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

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

Group	Value (micromoles/liter (μmol/L))	Spread
Abaloparatide-sMTS	-0.0030	0.0023

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Abaloparatide-sMTSAbaloparatide-sMTS was applied to the thigh for 5 minutes once daily for 29 days.	0 / 22	0 / 22	22 / 22

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: Clinical trial · 2021

13 results

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

Miller et al. 2021Clinical drug investigationcited by 19

PMID 33638863PMC7946681DOI 10.1007/s40261-021-01008-7PUB-33638863

Free to read · publisher termsCC BY-NC13 results

Read at source See results (13)

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: * 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

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