Trial Outcomes & Findings for 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 NCT04366726)

NCT ID: NCT04366726

Last Updated: 2023-11-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 22 participants
• Primary outcome timeframe: 0 (predose), 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours postdose on Day 29
• Results posted on: 2023-11-22

Participant Flow

Participant milestones

Measure	Abaloparatide-sMTS Abaloparatide-solid microstructured transdermal system (sMTS) 300 micrograms (μg) was applied to the thigh for 5 minutes once daily for 29 days.
Overall Study STARTED	22
Overall Study Received at Least 1 Dose of Study Drug	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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)

Baseline characteristics by cohort

Measure	Abaloparatide-sMTS n=22 Participants Abaloparatide-sMTS 300 μg was applied to the thigh for 5 minutes once daily for 29 days.
Age, Continuous	65.2 years STANDARD_DEVIATION 6.39 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

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

Population: The Pharmacokinetic Analysis Population included all participants who received at least 1 dose of study drug and who had sufficient evaluable plasma concentrations to reliably estimate 1 or more PK parameters.

Outcome measures

Measure	Abaloparatide-sMTS n=22 Participants Abaloparatide-sMTS 300 μg was applied to the thigh for 5 minutes once daily for 29 days.
Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29	399.6 picograms/milliliter (pg/mL) Geometric Coefficient of Variation 41.8

PRIMARY outcome

Timeframe: 0 (predose) and 4 hours postdose on Day 29

Population: The Pharmacokinetic Analysis Population included all participants who received at least 1 dose of study drug and had sufficient evaluable plasma concentrations to reliably estimate 1 or more PK parameters.

Outcome measures

Measure	Abaloparatide-sMTS n=22 Participants Abaloparatide-sMTS 300 μg was applied to the thigh for 5 minutes once daily for 29 days.
Abaloparatide Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) on Day 29	604.7 hour*pg/mL Geometric Coefficient of Variation 51.1

SECONDARY outcome

Timeframe: Baseline, Day 29

Population: The Bone Metabolism Population includes all participants in the Safety Population who have baseline and at least one post-baseline s-PINP.

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.

Outcome measures

Measure	Abaloparatide-sMTS n=22 Participants Abaloparatide-sMTS 300 μg was applied to the thigh for 5 minutes once daily for 29 days.
Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29	103.16 percent change Standard Deviation 104.729

SECONDARY outcome

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

Population: The Safety Population included all participants who received at least 1 dose of study medication.

Outcome measures

Measure	Abaloparatide-sMTS n=22 Participants Abaloparatide-sMTS 300 μg was applied to the thigh for 5 minutes once daily for 29 days.
Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29 Day 29, predose	-0.031 millimoles/liter (mmol/L) Standard Deviation 0.0986
Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29 Day 29, postdose	-0.002 millimoles/liter (mmol/L) Standard Deviation 0.0659

SECONDARY outcome

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

Population: The Safety Population includes all participants who received at least 1 dose of study drug.

Outcome measures

Measure	Abaloparatide-sMTS n=22 Participants Abaloparatide-sMTS 300 μg was applied to the thigh for 5 minutes once daily for 29 days.
Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29 Day 29, postdose	0.006 mmol/L Standard Deviation 0.1877
Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29 Day 29, predose	0.051 mmol/L Standard Deviation 0.1832

SECONDARY outcome

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

Population: The Safety Population included all participants who received at least 1 dose of study drug.

Outcome measures

Measure	Abaloparatide-sMTS n=22 Participants Abaloparatide-sMTS 300 μg was applied to the thigh for 5 minutes once daily for 29 days.
Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29 Day 29, predose	-0.0030 micromoles/liter (μmol/L) Standard Deviation 0.0023
Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29 Day 29, postdose	-0.0006 micromoles/liter (μmol/L) Standard Deviation 0.0046

Adverse Events

Abaloparatide-sMTS

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Abaloparatide-sMTS n=22 participants at risk Abaloparatide-sMTS was applied to the thigh for 5 minutes once daily for 29 days.
General disorders Application site erythema	100.0% 22/22 • Day 1 up to Day 36 The Safety Population included all participants who received at least 1 dose of study drug.
General disorders Application site haemorrhage	27.3% 6/22 • Day 1 up to Day 36 The Safety Population included all participants who received at least 1 dose of study drug.
General disorders Application site oedema	63.6% 14/22 • Day 1 up to Day 36 The Safety Population included all participants who received at least 1 dose of study drug.
General disorders Application site pain	90.9% 20/22 • Day 1 up to Day 36 The Safety Population included all participants who received at least 1 dose of study drug.
General disorders Application site pruritus	27.3% 6/22 • Day 1 up to Day 36 The Safety Population included all participants who received at least 1 dose of study drug.
General disorders Application site swelling	77.3% 17/22 • Day 1 up to Day 36 The Safety Population included all participants who received at least 1 dose of study drug.
Nervous system disorders Burning sensation	9.1% 2/22 • Day 1 up to Day 36 The Safety Population included all participants who received at least 1 dose of study drug.

Additional Information

Associate Director, Clinical Operations

Radius Health, Inc.

Phone: (617) 551-4000

Email: info@radiuspharm.com

Results disclosure agreements

• Principal investigator is a sponsor employee Results may not be published prior to the Study Report completion. Investigators may publish results, providing a manuscript to the Sponsor =/\> 30 days prior to its submission to a publisher. Sponsor will provide manuscript to Investigators =/\> 30 days prior to its submission. Investigator shall comply with Sponsor's policy, withholding publication for an additional 60 days to permit the Sponsor to obtain patent or other proprietary rights protection, if deemed necessary.
• Publication restrictions are in place

Restriction type: OTHER