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Clinical Trial Results:
A Randomized, Non-Inferiority, Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Abaloparatide-sMTS for the Treatment of Postmenopausal Women with Osteoporosis (the wearABLe Study)

Summary
EudraCT number	2019-004807-11
Trial protocol	HU DK BG
Global end of trial date	09 Nov 2021

Results information
Results version number	v2(current)
This version publication date	31 Mar 2023
First version publication date	25 Dec 2022
Other versions	v1
Version creation reason	Correction of full data set Revisions to align with ClinicalTrials.gov posting.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

BA058-05-021

ISRCTN number

US NCT number

NCT04064411

WHO universal trial number (UTN)

Sponsor organisation name

Radius Health, Inc.

Sponsor organisation address

22 Boston Wharf Road, 7th floor, Boston, MA, United States, 02210

Public contact

Radius Contact Information, Radius Health Inc., 1 6175514000, info@radiuspharm.com

Scientific contact

Radius Contact Information, Radius Health, Inc., 1 6175514000, info@radiuspharm.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

09 Nov 2021

Is this the analysis of the primary completion data?

Yes

Primary completion date

05 Oct 2021

Global end of trial reached?

Yes

Global end of trial date

09 Nov 2021

Was the trial ended prematurely?

Main objective of the trial

A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured transdermal system (sMTS) with abaloparatide-subcutaneous (SC).

Protection of trial subjects

The study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki, the guidelines for current Good Clinical Practice International Conference on Harmonization (ICH), the US Food and Drug Administration Code of Federal Regulations, and all other applicable local regulatory and ethical requirements.

Background therapy

Evidence for comparator

Actual start date of recruitment

05 Aug 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 352

Country: Number of subjects enrolled

Denmark: 16

Country: Number of subjects enrolled

Hungary: 29

Country: Number of subjects enrolled

Poland: 114

Worldwide total number of subjects

511

EEA total number of subjects

159

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

111

From 65 to 84 years

400

85 years and over

Subject disposition

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Recruitment details

Screening details

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.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Single blind

Roles blinded

Assessor ^[1]

Blinding implementation details

Treatment was not blinded to either the participants or investigators because of the differences in how study drug was administered. However, the central imaging laboratory responsible for measuring BMD was blinded to the participant’s treatment assignment throughout the study.

Are arms mutually exclusive

Yes

Abaloparatide-SC

Arm description

Participants self-administered daily doses of abaloparatide 80 micrograms (mcg) SC for 12 months using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.

Arm type

Experimental

Investigational medicinal product name

abaloparatide

Investigational medicinal product code

Other name

TYMLOS®, BA058, abaloparatide-SC

Pharmaceutical forms

Solution for injection in pre-filled pen

Routes of administration

Subcutaneous use

Dosage and administration details

Abaloparatide was administered per dose and schedule specified in the arm description.

Abaloparatide-sMTS

Arm description

Participants self-administered abaloparatide-sMTS 300 mcg applied to the thigh for 5 minutes daily for 12 months.

Arm type

Active comparator

Investigational medicinal product name

abaloparatide solid microstructured transdermal system

Investigational medicinal product code

Other name

BA058, abaloparatide-transdermal

Pharmaceutical forms

Transdermal system

Routes of administration

Transdermal use

Dosage and administration details

Abaloparatide-sMTS was administered per dose and schedule specified in the arm description.

Notes
[1] - The roles blinded appear inconsistent with a simple blinded trial.
Justification: Treatment was not blinded to either the participants or Investigators because of the differences in how study drug was administered.

Number of subjects in period 1	Abaloparatide-SC	Abaloparatide-sMTS
Started	255	256
Received at Least 1 Dose of Study Drug	254	252
Completed	191	201
Not completed	64	55
Adverse event, serious fatal	1	-
Consent withdrawn by subject	25	29
Adverse event, non-fatal	29	19
Protocol Deviation	-	2
Significant Deterioration from Baseline of BMD	-	2
Other than Specified	4	1
Lost to follow-up	5	2

Baseline characteristics

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Reporting group title

Abaloparatide-SC

Reporting group description

Reporting group title

Abaloparatide-sMTS

Reporting group description

Participants self-administered abaloparatide-sMTS 300 mcg applied to the thigh for 5 minutes daily for 12 months.

Reporting group values	Abaloparatide-SC	Abaloparatide-sMTS	Total
Number of subjects	255	256	511
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	59	52	111
From 65-84 years	196	204	400
85 years and over	0	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	68.8 ± 6.87	69.3 ± 6.49	-
Sex: Female, Male
Units: participants
Female	255	256	511
Male	0	0	0
Race
Units: Subjects
White	248	243	491
Black or African American	4	4	8
Asian	1	1	2
American Indian or Alaska Native	0	1	1
Multiple	0	3	3
Other	2	4	6
Ethnicity
Units: Subjects
Hispanic or Latino	27	24	51
Not Hispanic or Latino	227	230	457
Unknown	1	2	3
Lumbar Spine BMD T-Score
The BMD T-score is the BMD, assessed by dual energy x-ray absorptiometry (DXA), at the site when compared to that of a healthy woman (20 to 29 years old). Normal is a T-score of -1.0 or higher; Osteopenia is defined as between -1.0 and -2.5; Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and a half standard deviations below the mean of a woman (20 to 29 years old). Lower T-scores indicate worse bone condition. Analysis includes participants who had lumbar spine BMD T-Score assessment at baseline.
Units: T-Score
arithmetic mean (standard deviation)	-2.569 ± 1.1534	-2.554 ± 1.0997	-

End points

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Reporting group title

Abaloparatide-SC

Reporting group description

Reporting group title

Abaloparatide-sMTS

Reporting group description

Participants self-administered abaloparatide-sMTS 300 mcg applied to the thigh for 5 minutes daily for 12 months.

Primary: Percent Change from Baseline in Lumbar Spine BMD at Month 12

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End point title

Percent Change from Baseline in Lumbar Spine BMD at Month 12

End point description

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

End point type

Primary

End point timeframe

Baseline, Month 12

End point values	Abaloparatide-SC	Abaloparatide-sMTS
Number of subjects analysed	189	200
Units: percent change
least squares mean (standard error)	10.8571 ± 0.4755	7.1361 ± 0.4605

Percent Change from Baseline in Lumbar Spine BMD

Statistical analysis description

Percent change from baseline in lumbar spine BMD at Month 12.

Comparison groups

Abaloparatide-SC v Abaloparatide-sMTS

Number of subjects included in analysis

389

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[1]

Method

Parameter type

Least Squares Means (LSM) Difference

Point estimate

-3.721

Confidence interval

level

95%

sides

2-sided

lower limit

-5.0089

upper limit

-2.4331

Notes
[1] - Noninferiority margin = 2.0% for abaloparatide-sMTS compared with abaloparatide-SC. Non-inferiority was to be concluded if the lower bound of the 2-sided 95% Confidence Interval (CI) for the estimated treatment difference (abaloparatide-sMTS minus abaloparatide-SC) in the percent change from baseline in lumbar spine BMD at 12 months was above -2.0% using a Mixed Model for Repeated Measures (MMRM) analysis.

Secondary: Percent Change from Baseline in Total Hip BMD at Month 12

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End point title

Percent Change from Baseline in Total Hip BMD at Month 12

End point description

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

End point type

Secondary

End point timeframe

Baseline, Month 12

End point values	Abaloparatide-SC	Abaloparatide-sMTS
Number of subjects analysed	188	200
Units: percent change
least squares mean (standard error)	3.6995 ± 0.2776	1.9688 ± 0.2675

No statistical analyses for this end point

Secondary: Percent Change from Baseline in Femoral Neck BMD at Month 12

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End point title

Percent Change from Baseline in Femoral Neck BMD at Month 12

End point description

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

End point type

Secondary

End point timeframe

Baseline, Month 12

End point values	Abaloparatide-SC	Abaloparatide-sMTS
Number of subjects analysed	188	200
Units: percent change
least squares mean (standard error)	3.4159 ± 0.3750	1.9163 ± 0.3599

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Baseline through Month 13

Adverse event reporting additional description

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.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

Abaloparatide-SC

Reporting group description

Participants self-administered daily doses of abaloparatide 80 mcg SC for 12 months using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.

Reporting group title

Abaloparatide-sMTS

Reporting group description

Participants self-administered abaloparatide-sMTS 300 mcg applied to the thigh for 5 minutes daily for 12 months.

Serious adverse events	Abaloparatide-SC	Abaloparatide-sMTS
Total subjects affected by serious adverse events
subjects affected / exposed	19 / 254 (7.48%)	16 / 252 (6.35%)
number of deaths (all causes)	1	0
number of deaths resulting from adverse events	1	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
subjects affected / exposed	1 / 254 (0.39%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma stage IV
subjects affected / exposed	1 / 254 (0.39%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	1 / 254 (0.39%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	1 / 254 (0.39%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Hypotension
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	1 / 254 (0.39%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pleural effusion
subjects affected / exposed	2 / 254 (0.79%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	1 / 254 (0.39%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	1 / 254 (0.39%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	1 / 254 (0.39%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	1 / 254 (0.39%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	1 / 254 (0.39%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	1 / 254 (0.39%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block left
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Metabolic encephalopathy
subjects affected / exposed	1 / 254 (0.39%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Normal pressure hydrocephalus
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient global amnesia
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain oedema
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Iridocyclitis
subjects affected / exposed	1 / 254 (0.39%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	1 / 254 (0.39%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cannabinoid hyperemesis syndrome
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Polyarthritis
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	1 / 254 (0.39%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
COVID-19
subjects affected / exposed	1 / 254 (0.39%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
COVID-19 pneumonia
subjects affected / exposed	2 / 254 (0.79%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypercalcaemia
subjects affected / exposed	1 / 254 (0.39%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	0 / 254 (0.00%)	1 / 252 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	1 / 254 (0.39%)	0 / 252 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Abaloparatide-SC	Abaloparatide-sMTS
Total subjects affected by non serious adverse events
subjects affected / exposed	204 / 254 (80.31%)	239 / 252 (94.84%)
Vascular disorders
Orthostatic hypotension
subjects affected / exposed	20 / 254 (7.87%)	19 / 252 (7.54%)
occurrences all number	27	20
Hypertension
subjects affected / exposed	15 / 254 (5.91%)	8 / 252 (3.17%)
occurrences all number	16	8
Cardiac disorders
Palpitations
subjects affected / exposed	18 / 254 (7.09%)	6 / 252 (2.38%)
occurrences all number	22	7
Nervous system disorders
Headache
subjects affected / exposed	41 / 254 (16.14%)	25 / 252 (9.92%)
occurrences all number	46	28
Dizziness
subjects affected / exposed	24 / 254 (9.45%)	17 / 252 (6.75%)
occurrences all number	28	18
General disorders and administration site conditions
Administration site erythema
subjects affected / exposed	4 / 254 (1.57%)	13 / 252 (5.16%)
occurrences all number	4	13
Application site swelling
subjects affected / exposed	6 / 254 (2.36%)	116 / 252 (46.03%)
occurrences all number	6	124
Application site oedema
subjects affected / exposed	1 / 254 (0.39%)	122 / 252 (48.41%)
occurrences all number	1	128
Application site discolouration
subjects affected / exposed	0 / 254 (0.00%)	37 / 252 (14.68%)
occurrences all number	0	37
Application site haemorrhage
subjects affected / exposed	2 / 254 (0.79%)	73 / 252 (28.97%)
occurrences all number	2	78
Application site erythema
subjects affected / exposed	15 / 254 (5.91%)	190 / 252 (75.40%)
occurrences all number	15	205
Application site vesicles
subjects affected / exposed	1 / 254 (0.39%)	16 / 252 (6.35%)
occurrences all number	1	16
Application site reaction
subjects affected / exposed	0 / 254 (0.00%)	18 / 252 (7.14%)
occurrences all number	0	20
Application site pruritus
subjects affected / exposed	10 / 254 (3.94%)	83 / 252 (32.94%)
occurrences all number	10	87
Application site pain
subjects affected / exposed	14 / 254 (5.51%)	142 / 252 (56.35%)
occurrences all number	23	289
Injection site pain
subjects affected / exposed	82 / 254 (32.28%)	17 / 252 (6.75%)
occurrences all number	164	26
Injection site erythema
subjects affected / exposed	119 / 254 (46.85%)	26 / 252 (10.32%)
occurrences all number	131	27
Injection site haemorrhage
subjects affected / exposed	30 / 254 (11.81%)	6 / 252 (2.38%)
occurrences all number	30	6
Injection site swelling
subjects affected / exposed	48 / 254 (18.90%)	10 / 252 (3.97%)
occurrences all number	49	10
Fatigue
subjects affected / exposed	14 / 254 (5.51%)	6 / 252 (2.38%)
occurrences all number	14	7
Injection site bruising
subjects affected / exposed	35 / 254 (13.78%)	1 / 252 (0.40%)
occurrences all number	37	1
Injection site oedema
subjects affected / exposed	31 / 254 (12.20%)	12 / 252 (4.76%)
occurrences all number	32	12
Injection site pruritus
subjects affected / exposed	48 / 254 (18.90%)	9 / 252 (3.57%)
occurrences all number	51	9
Gastrointestinal disorders
Nausea
subjects affected / exposed	35 / 254 (13.78%)	14 / 252 (5.56%)
occurrences all number	49	14
Renal and urinary disorders
Hypercalciuria
subjects affected / exposed	6 / 254 (2.36%)	13 / 252 (5.16%)
occurrences all number	7	13
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	26 / 254 (10.24%)	14 / 252 (5.56%)
occurrences all number	34	14
Arthralgia
subjects affected / exposed	20 / 254 (7.87%)	25 / 252 (9.92%)
occurrences all number	25	29
Pain in extremity
subjects affected / exposed	17 / 254 (6.69%)	11 / 252 (4.37%)
occurrences all number	19	15
Infections and infestations
COVID-19
subjects affected / exposed	18 / 254 (7.09%)	9 / 252 (3.57%)
occurrences all number	18	10
Urinary tract infection
subjects affected / exposed	20 / 254 (7.87%)	23 / 252 (9.13%)
occurrences all number	20	27

More information

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Were there any global substantial amendments to the protocol? Yes

17 Jun 2019

• Updated inclusion criterion 3 for previous fractures to clarify that participants were required to meet only 1 and not both of the fracture requirements • Added that if sensitization was suspected, the Investigator was to contact the Sponsor for further instructions • Removed the requirement for the signing of an additional Informed Consent Form advising participants who sustained an incident fracture and elected to remain in the study that they were at increased risk for a subsequent fracture • Added that the radiographs of the lateral thoracic and lumbar spine at Screening would be assessed locally using the Genant Semi-Quantitative Scoring Method

17 Jun 2019

• Updated inclusion criterion for postmenopausal women as either a history of amenorrhea for at least 5 years or by an elevated follicle-stimulating hormone (FSH) value ≥30 International units per litre (IU/L) • Added that any subject with a thyroid stimulating hormone (TSH) value outside of the normal range was required to have T3 and free T4 tested, with results within the normal range in order to be enrolled • Added that bone-specific alkaline phosphatase testing was required only if alkaline phosphatase levels were outside of the normal range • Reduced the frequency of 4 hour postdose blood draws for evaluation of calcium

01 Oct 2019

• Removed the FSH value ≥30 IU/L from inclusion criterion for postmenopausal women

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A Randomized, Non-Inferiority, Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Abaloparatide-sMTS for the Treatment of Postmenopausal Women with Osteoporosis (the wearABLe Study)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percent Change from Baseline in Lumbar Spine BMD at Month 12

Primary: Percent Change from Baseline in Lumbar Spine BMD at Month 12

Secondary: Percent Change from Baseline in Total Hip BMD at Month 12

Secondary: Percent Change from Baseline in Total Hip BMD at Month 12

Secondary: Percent Change from Baseline in Femoral Neck BMD at Month 12

Secondary: Percent Change from Baseline in Femoral Neck BMD at Month 12

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
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Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Randomized, Non-Inferiority, Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Abaloparatide-sMTS for the Treatment of Postmenopausal Women with Osteoporosis (the wearABLe Study)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percent Change from Baseline in Lumbar Spine BMD at Month 12

Primary: Percent Change from Baseline in Lumbar Spine BMD at Month 12

Secondary: Percent Change from Baseline in Total Hip BMD at Month 12

Secondary: Percent Change from Baseline in Total Hip BMD at Month 12

Secondary: Percent Change from Baseline in Femoral Neck BMD at Month 12

Secondary: Percent Change from Baseline in Femoral Neck BMD at Month 12

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Randomized, Non-Inferiority, Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Abaloparatide-sMTS for the Treatment of Postmenopausal Women with Osteoporosis (the wearABLe Study)