Trial · NCT04064411

Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis

NCT04064411, Phase 3, Completed, Radius Health, Inc.; results first posted 2023-02-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis. Trials, record NCT04064411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04064411

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis
NCT number: NCT04064411
Status: Completed
Phases: Phase 3
Enrollment: 511 participants, actual
Lead sponsor: Radius Health, Inc.
Conditions: Postmenopausal Osteoporosis
Interventions: abaloparatide, abaloparatide solid microstructured transdermal system
First posted: 2019-08-21
Last updated: 2023-02-15
Results first posted: 2023-02-15

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in Lumbar Spine BMD at Month 12	Baseline, Month 12	Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory.
Secondary	Percent Change From Baseline in Total Hip BMD at Month 12	Baseline, Month 12	Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory.
Secondary	Percent Change From Baseline in Femoral Neck BMD at Month 12	Baseline, Month 12	Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline in Lumbar Spine BMD at Month 12	Baseline, Month 12	Modified Intention-to-Treat (mITT): All randomized participants who received at least 1 dose of study drug and had a baseline lumbar spine BMD measurement and at least 1 postbaseline lumbar spine BMD measurement. Overall number of participants analyzed = participants with valid assessments at both baseline and Month 12.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Total Hip BMD at Month 12	Baseline, Month 12	mITT: All randomized participants who received at least 1 dose of study drug and had a baseline lumbar spine BMD measurement and at least 1 postbaseline lumbar spine BMD measurement. Overall number of participants analyzed = participants with valid assessments at both baseline and Month 12.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Femoral Neck BMD at Month 12	Baseline, Month 12	mITT: All randomized participants who received at least 1 dose of study drug and had a baseline lumbar spine BMD measurement and at least 1 postbaseline lumbar spine BMD measurement. Overall number of participants analyzed = participants with valid assessments at both baseline and Month 12.	percent change	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Change From Baseline in Lumbar Spine BMD at Month 12	Abaloparatide-SC	10.8571	Standard Error 0.4755	percent change
Percent Change From Baseline in Lumbar Spine BMD at Month 12	Abaloparatide-sMTS	7.1361	Standard Error 0.4605	percent change
Percent Change From Baseline in Total Hip BMD at Month 12	Abaloparatide-SC	3.6995	Standard Error 0.2776	percent change
Percent Change From Baseline in Total Hip BMD at Month 12	Abaloparatide-sMTS	1.9688	Standard Error 0.2675	percent change
Percent Change From Baseline in Femoral Neck BMD at Month 12	Abaloparatide-SC	3.4159	Standard Error 0.3750	percent change
Percent Change From Baseline in Femoral Neck BMD at Month 12	Abaloparatide-sMTS	1.9163	Standard Error 0.3599	percent change

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Abaloparatide-SC	255
Overall Study	STARTED	Abaloparatide-sMTS	256
Overall Study	Received at Least 1 Dose of Study Drug	Abaloparatide-SC	254
Overall Study	Received at Least 1 Dose of Study Drug	Abaloparatide-sMTS	252
Overall Study	COMPLETED	Abaloparatide-SC	191
Overall Study	COMPLETED	Abaloparatide-sMTS	201
Overall Study	NOT COMPLETED	Abaloparatide-SC	64
Overall Study	NOT COMPLETED	Abaloparatide-sMTS	55

Source ClinicalTrials.gov

Adverse events140

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Administration site erythema	General disorders	Abaloparatide-SC	4	254	4
other	Administration site erythema	General disorders	Abaloparatide-sMTS	13	252	13
other	Application site discolouration	General disorders	Abaloparatide-SC	0	254	0
other	Application site discolouration	General disorders	Abaloparatide-sMTS	37	252	37
other	Application site erythema	General disorders	Abaloparatide-SC	15	254	15
other	Application site erythema	General disorders	Abaloparatide-sMTS	190	252	205
other	Application site haemorrhage	General disorders	Abaloparatide-SC	2	254	2
other	Application site haemorrhage	General disorders	Abaloparatide-sMTS	73	252	78
other	Application site oedema	General disorders	Abaloparatide-SC	1	254	1
other	Application site oedema	General disorders	Abaloparatide-sMTS	122	252	128

1 to 10 of 140Source ClinicalTrials.gov

See all 140 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Abaloparatide-SC	1	254
Total, all-cause mortality	Abaloparatide-sMTS	0	252
Total, other adverse events	Abaloparatide-SC	204	254
Total, other adverse events	Abaloparatide-sMTS	239	252
Total, serious adverse events	Abaloparatide-SC	19	254
Total, serious adverse events	Abaloparatide-sMTS	16	252

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37417725	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Abaloparatide-SC vs Abaloparatide-sMTS: deaths from any cause	Trial comparisons
Abaloparatide-SC vs Abaloparatide-sMTS: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04064411

GET https://conductscience.org/api/trials/v1/NCT04064411/events?page=2

API reference For AI assistants