Trial Outcomes & Findings for Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis (NCT NCT04064411)

NCT ID: NCT04064411

Last Updated: 2023-02-15

Results Overview

Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

511 participants

Primary outcome timeframe

Baseline, Month 12

Results posted on

2023-02-15

Participant Flow

Eligible female participants were randomized to a 12-month open-label study treatment at 83 study centers in the United States, Denmark, Hungary, and Poland.

Participant milestones

Participant milestones
Measure	Abaloparatide-SC Participants self-administered daily doses of abaloparatide 80 micrograms (mcg) subcutaneous (SC) using a single-participant, multiple-use, prefilled injection pen.	Abaloparatide-sMTS Participants self-administered daily doses of abaloparatide solid microstructured transdermal system (sMTS) 300 mcg.
Overall Study STARTED	255	256
Overall Study Received at Least 1 Dose of Study Drug	254	252
Overall Study COMPLETED	191	201
Overall Study NOT COMPLETED	64	55

Reasons for withdrawal

Reasons for withdrawal
Measure	Abaloparatide-SC Participants self-administered daily doses of abaloparatide 80 micrograms (mcg) subcutaneous (SC) using a single-participant, multiple-use, prefilled injection pen.	Abaloparatide-sMTS Participants self-administered daily doses of abaloparatide solid microstructured transdermal system (sMTS) 300 mcg.
Overall Study Adverse Event	29	19
Overall Study Significant Deterioration from Baseline (≥7%) of Bone Mineral Density (BMD) at Spine or Hip	0	2
Overall Study Protocol Deviation	0	2
Overall Study Withdrawal by Subject	25	29
Overall Study Lost to Follow-up	5	2
Overall Study Other than Specified	4	1
Overall Study Death	1	0

Baseline Characteristics

Participants who had lumbar spine BMD T-Score assessment at baseline.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abaloparatide-SC n=255 Participants Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen.	Abaloparatide-sMTS n=256 Participants Participants self-administered daily doses of abaloparatide-sMTS 300 mcg.	Total n=511 Participants Total of all reporting groups
Race/Ethnicity, Customized Race: Black or African American	4 Participants n=255 Participants	4 Participants n=256 Participants	8 Participants n=511 Participants
Race/Ethnicity, Customized Race: Asian	1 Participants n=255 Participants	1 Participants n=256 Participants	2 Participants n=511 Participants
Race/Ethnicity, Customized Race: American Indian or Alaska Native	0 Participants n=255 Participants	1 Participants n=256 Participants	1 Participants n=511 Participants
Race/Ethnicity, Customized Race: Multiple	0 Participants n=255 Participants	3 Participants n=256 Participants	3 Participants n=511 Participants
Race/Ethnicity, Customized Race: Other	2 Participants n=255 Participants	4 Participants n=256 Participants	6 Participants n=511 Participants
Race/Ethnicity, Customized Ethnicity: Hispanic or Latino	27 Participants n=255 Participants	24 Participants n=256 Participants	51 Participants n=511 Participants
Age, Continuous	68.8 years STANDARD_DEVIATION 6.87 • n=255 Participants	69.3 years STANDARD_DEVIATION 6.49 • n=256 Participants	69.1 years STANDARD_DEVIATION 6.68 • n=511 Participants
Sex: Female, Male Female	255 Participants n=255 Participants	256 Participants n=256 Participants	511 Participants n=511 Participants
Sex: Female, Male Male	0 Participants n=255 Participants	0 Participants n=256 Participants	0 Participants n=511 Participants
Race/Ethnicity, Customized White	248 Participants n=255 Participants	243 Participants n=256 Participants	491 Participants n=511 Participants
Race/Ethnicity, Customized Ethnicity: Not Hispanic or Latino	227 Participants n=255 Participants	230 Participants n=256 Participants	457 Participants n=511 Participants
Race/Ethnicity, Customized Ethnicity: Unknown	1 Participants n=255 Participants	2 Participants n=256 Participants	3 Participants n=511 Participants
Lumbar Spine BMD T-Score	-2.569 BMD T-Score STANDARD_DEVIATION 1.1534 • n=252 Participants • Participants who had lumbar spine BMD T-Score assessment at baseline.	-2.554 BMD T-Score STANDARD_DEVIATION 1.0997 • n=254 Participants • Participants who had lumbar spine BMD T-Score assessment at baseline.	-2.562 BMD T-Score STANDARD_DEVIATION 1.1257 • n=506 Participants • Participants who had lumbar spine BMD T-Score assessment at baseline.

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: 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.

Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory.

Outcome measures

Outcome measures
Measure	Abaloparatide-SC n=189 Participants Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen.	Abaloparatide-sMTS n=200 Participants Participants self-administered daily doses of abaloparatide-sMTS 300 mcg.
Percent Change From Baseline in Lumbar Spine BMD at Month 12	10.8571 percent change Standard Error 0.4755	7.1361 percent change Standard Error 0.4605

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: 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.

Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory.

Outcome measures

Outcome measures
Measure	Abaloparatide-SC n=188 Participants Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen.	Abaloparatide-sMTS n=200 Participants Participants self-administered daily doses of abaloparatide-sMTS 300 mcg.
Percent Change From Baseline in Total Hip BMD at Month 12	3.6995 percent change Standard Error 0.2776	1.9688 percent change Standard Error 0.2675

SECONDARY outcome

Timeframe: Baseline, Month 12

Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory.

Outcome measures

Outcome measures
Measure	Abaloparatide-SC n=188 Participants Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen.	Abaloparatide-sMTS n=200 Participants Participants self-administered daily doses of abaloparatide-sMTS 300 mcg.
Percent Change From Baseline in Femoral Neck BMD at Month 12	3.4159 percent change Standard Error 0.3750	1.9163 percent change Standard Error 0.3599

Adverse Events

Abaloparatide-SC

Serious events: 19 serious events

Other events: 204 other events

Deaths: 1 deaths

Abaloparatide-sMTS

Serious events: 16 serious events

Other events: 239 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Operations

Radius Health, Inc.

Phone: 617-551-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Abaloparatide-SC n=254 participants at risk Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen.	Abaloparatide-sMTS n=252 participants at risk Participants self-administered daily doses of abaloparatide-sMTS 300 mcg.
General disorders Administration site erythema	1.6% 4/254 • Number of events 4 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	5.2% 13/252 • Number of events 13 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Application site discolouration	0.00% 0/254 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	14.7% 37/252 • Number of events 37 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Application site erythema	5.9% 15/254 • Number of events 15 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	75.4% 190/252 • Number of events 205 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Application site haemorrhage	0.79% 2/254 • Number of events 2 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	29.0% 73/252 • Number of events 78 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Application site oedema	0.39% 1/254 • Number of events 1 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	48.4% 122/252 • Number of events 128 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Application site pain	5.5% 14/254 • Number of events 23 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	56.3% 142/252 • Number of events 289 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Application site pruritus	3.9% 10/254 • Number of events 10 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	32.9% 83/252 • Number of events 87 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Application site reaction	0.00% 0/254 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	7.1% 18/252 • Number of events 20 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Application site swelling	2.4% 6/254 • Number of events 6 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	46.0% 116/252 • Number of events 124 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Application site vesicles	0.39% 1/254 • Number of events 1 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	6.3% 16/252 • Number of events 16 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	7.9% 20/254 • Number of events 25 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	9.9% 25/252 • Number of events 29 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	10.2% 26/254 • Number of events 34 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	5.6% 14/252 • Number of events 14 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
Infections and infestations COVID-19	7.1% 18/254 • Number of events 18 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	3.6% 9/252 • Number of events 10 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	9.4% 24/254 • Number of events 28 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	6.7% 17/252 • Number of events 18 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Fatigue	5.5% 14/254 • Number of events 14 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	2.4% 6/252 • Number of events 7 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Headache	16.1% 41/254 • Number of events 46 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	9.9% 25/252 • Number of events 28 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Hypercalciuria	2.4% 6/254 • Number of events 7 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	5.2% 13/252 • Number of events 13 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	5.9% 15/254 • Number of events 16 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	3.2% 8/252 • Number of events 8 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Injection site bruising	13.8% 35/254 • Number of events 37 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	0.40% 1/252 • Number of events 1 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Injection site erythema	46.9% 119/254 • Number of events 131 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	10.3% 26/252 • Number of events 27 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Injection site haemorrhage	11.8% 30/254 • Number of events 30 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	2.4% 6/252 • Number of events 6 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Injection site oedema	12.2% 31/254 • Number of events 32 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	4.8% 12/252 • Number of events 12 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Injection site pain	32.3% 82/254 • Number of events 164 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	6.7% 17/252 • Number of events 26 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Injection site pruritus	18.9% 48/254 • Number of events 51 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	3.6% 9/252 • Number of events 9 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
General disorders Injection site swelling	18.9% 48/254 • Number of events 49 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	4.0% 10/252 • Number of events 10 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	13.8% 35/254 • Number of events 49 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	5.6% 14/252 • Number of events 14 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
Vascular disorders Orthostatic hypotension	7.9% 20/254 • Number of events 27 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	7.5% 19/252 • Number of events 20 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 17/254 • Number of events 19 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	4.4% 11/252 • Number of events 15 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Palpitations	7.1% 18/254 • Number of events 22 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	2.4% 6/252 • Number of events 7 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	7.9% 20/254 • Number of events 20 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.	9.1% 23/252 • Number of events 27 • Day 1 (after dosing) through Month 13 All-Cause Mortality, Serious, and Other Adverse Events were assessed in the Safety Population: All randomized participants who received at least 1 dose of study drug.