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

Sponsor

Radius Health, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04064411

Collaborator

(none)

474

Enrollment

Locations

Arms

28.2

Actual Duration (Months)

4.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A 12-month study to compare the efficacy and safety of abaloparatide-sMTS with abaloparatide-subcutaneous (SC)

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Osteoporosis	Combination Product: abaloparatide solid microstructured transdermal system Combination Product: abaloparatide-SC	Phase 3

Detailed Description

This study aims to evaluate the non-inferiority of abaloparatide-sMTS 300 μg compared to abaloparatide-SC 80 μg based on lumbar spine bone mineral density (BMD) at 12 months and to evaluate the safety and tolerability of abaloparatide-sMTS in the treatment of postmenopausal women with osteoporosis

Study Design

Study Type:

Interventional

Actual Enrollment :

474 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

parallel assignmentparallel assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

outcomes assessor

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Aug 5, 2019

Actual Primary Completion Date :

Oct 13, 2021

Actual Study Completion Date :

Dec 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: abaloparatide-sMTS Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide, which is an active synthetic peptide of parathyroid hormone, coated onto a sMTS array for transdermal administration of abaloparatide	Combination Product: abaloparatide solid microstructured transdermal system abaloparatide 300 μg applied to the thigh for 5 minutes once daily for 12 months Other Names: BA058; abaloparatide-transdermal
Active Comparator: abaloparatide-SC A combination product consisting of the drug abaloparatide in a single-patient-use prefilled pen that delivers 80 μg of abaloparatide as a SC injection	Combination Product: abaloparatide-SC abaloparatide 80 μg injected into the abdomen once daily for 12 months Other Names: TYMLOS®; BA058

Arm

Intervention/Treatment

Experimental: abaloparatide-sMTS

Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide, which is an active synthetic peptide of parathyroid hormone, coated onto a sMTS array for transdermal administration of abaloparatide

Combination Product: abaloparatide solid microstructured transdermal system

abaloparatide 300 μg applied to the thigh for 5 minutes once daily for 12 months

Other Names:

BA058; abaloparatide-transdermal

Active Comparator: abaloparatide-SC

A combination product consisting of the drug abaloparatide in a single-patient-use prefilled pen that delivers 80 μg of abaloparatide as a SC injection

Combination Product: abaloparatide-SC

abaloparatide 80 μg injected into the abdomen once daily for 12 months

Other Names:

TYMLOS®; BA058

Outcome Measures

Primary Outcome Measures

Percent change from baseline in lumbar spine BMD at 12 months [12 months]
percent change from baseline in BMD of lumbar spine using dual-energy X-ray absorptiometry (DXA) results; abaloparatide-sMTS compared with abaloparatide-SC

Secondary Outcome Measures

Percent change from baseline in total hip BMD at 12 months [12 months]
percent change from baseline in BMD of total hip using DXA results; abaloparatide-sMTS compared with abaloparatide-SC
Percent change from baseline in femoral neck BMD at 12 months [12 months]
percent change from baseline in BMD of femoral neck using DXA results; abaloparatide-sMTS compared with abaloparatide-SC

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Healthy ambulatory female from 50 to 85 years of age (inclusive) with postmenopausal osteoporosis
Subjects who are 50 to 65 years old with BMD T score ≤ -2.5 and > -5.0 at the lumbar spine or hip (femoral neck or total hip) by DXA and meet one of the following: 1) radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures or 2) history of fragility fracture to the forearm, humerus, sacrum, pelvis, hip, femur, or tibia within the past 5 years.
Subjects older than 65 years with BMD T score ≤ -2.0 and > -5.0 who meet the fracture criteria may be enrolled
Subjects older than 65 years with BMD T score ≤ -3.0 and > -5.0 at the lumbar spine or hip (femoral neck or total hip) by DXA
Body mass index of 18.5 to 33 kg/m^2, inclusive
serum calcium (albumin-corrected), PTH(1-84), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone within the normal reference range
Serum 25-hydroxyvitamin D values must be ≥ 20 ng/mL

Exclusion Criteria:

History of more than 4 mild or moderate spine fractures or any severe fracture
Abnormality of the spine or hip that would prohibit assessment of BMD
History of bone disorders other than postmenopausal osteoporosis or a diagnosis of cancer within the last 5 years
History of Cushing's disease, thyroid, parathyroid, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient
Prior treatment with parathyroid hormone, parathyroid hormone-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or parathyroid hormone (1-84)
Prior treatment with bisphosphonates within the past 3 years; fluoride or strontium within the past 5 years; treatment with corticosteroids within the past 12 months; or selective estrogen receptor modulators within the past 6 months (except hormone replacement therapy)
Prior treatment with an investigational drug or device within the past 90 days or 5 half-lives of the investigational drug, whichever is longer
History of nephrolithiasis or urolithiasis within the past 5 years or hereditary disorders predisposing to osteosarcoma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Hospital at Birmingham	Birmingham	Alabama	United States	35294
2	Orthopedic Physician Alaska - Rheumatology	Anchorage	Alaska	United States	354800
3	Arizona Arthritis & Rheumatology Research, PLLC - Research Center - Glendale	Glendale	Arizona	United States	85306
4	Arizona Arthritis & Rheumatology Research, PLLC	Mesa	Arizona	United States	85210
5	SunValley Arthritis Center Ltd.	Peoria	Arizona	United States	85381
6	Clinical Research Consortium	Tempe	Arizona	United States	85283
7	Arthritis & Rheumatism	Jonesboro	Arkansas	United States	72401
8	Advanced Clinical Research (ACR) - Rancho Paseo	Banning	California	United States	92220
9	Osteoporosis Medical Center	Beverly Hills	California	United States	90211
10	Clinical Trials of St. Jude Heritage Medical Group through S	Fullerton	California	United States	92835
11	Allied Clinical Research	Gold River	California	United States	95670
12	Marin Endocrine Care & Research, Inc.	Greenbrae	California	United States	94904
13	St. Joseph Heritage Healthcare	Mission Viejo	California	United States	92691
14	Northern California Institute for Bone Health Inc.	Orinda	California	United States	94563
15	Alta California Medical Group, Inc.	Simi Valley	California	United States	93065
16	Lynn Institute of Denver	Aurora	Colorado	United States	80012
17	MedStar Georgetown University Hospital - Department of Obstetrics and Gynecology	Washington	District of Columbia	United States	20007
18	UNC School of Medicine	Boca Raton	Florida	United States	33486
19	Bay Area Arthritis And Osteoporosis	Brandon	Florida	United States	33511
20	Clinical Research of West Florida	Clearwater	Florida	United States	33765
21	Shrock Orthopaedic Research, LLC	Fort Lauderdale	Florida	United States	33316
22	Clinical Physiology Associates, an AMR company	Fort Myers	Florida	United States	33912
23	Palm Springs Research Institute	Hialeah	Florida	United States	33012
24	Health Awareness INC	Jupiter	Florida	United States	33458
25	Sweet Hope Research Specialty	Miami Beach	Florida	United States	33140
26	Lakes Research, LLC	Miami Lakes	Florida	United States	33014
27	Global Health Research Center	Miami Lakes	Florida	United States	33016
28	Suncoast Research Group, LLC	Miami	Florida	United States	33135
29	Rheumatic Wellness Institute	Miami	Florida	United States	33143
30	BDA Research	Miami	Florida	United States	33156
31	Center for Arthritis and Rheumatic Diseases	Miami	Florida	United States	33173
32	Renstar Medical Research	Ocala	Florida	United States	34470
33	West Orange Endocrinology	Ocoee	Florida	United States	34761
34	Integral Rheumatology & Immunology Specialist	Plantation	Florida	United States	33324
35	Health Awareness, Inc.	Port Saint Lucie	Florida	United States	34952
36	Center for Advanced Research & Education	Gainesville	Georgia	United States	30501
37	Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian	Boise	Idaho	United States	83642
38	St. Luke's Clinic - Rheumatology	Boise	Idaho	United States	83702
39	Rush University Medical Center	Chicago	Illinois	United States	60612
40	The University of Chicago Medicine	Chicago	Illinois	United States	60637
41	MediSphere Medical Research Center	Evansville	Indiana	United States	47714
42	Northeast Iowa Medical Education Foundation	Waterloo	Iowa	United States	50702
43	Premier Medical Group, PSC	Owensboro	Kentucky	United States	42303
44	MedStar Health Center	Baltimore	Maryland	United States	21239
45	Rheumatology Consultants	Cumberland	Maryland	United States	21502
46	Othopaedic Associates of Michigan PC	Grand Rapids	Michigan	United States	49525
47	Montana Medical Research, Inc	Missoula	Montana	United States	59808
48	New Mexico Clinical Research	Albuquerque	New Mexico	United States	87106
49	The Endocrine Group	Albany	New York	United States	12206
50	Long Island Regional Arthritis & Osteoporosis Care PC	Babylon	New York	United States	11702
51	Physicians East, PA	Greenville	North Carolina	United States	27834
52	Cape Fear Arthritis Care	Leland	North Carolina	United States	28451
53	Carteret Medical Group	Morehead City	North Carolina	United States	28557
54	Carolina Arthritis Associates	Wilmington	North Carolina	United States	28401
55	Cleveland Clinic	Cleveland	Ohio	United States	44195
56	Clinical Radiology Of Oklahoma	Edmond	Oklahoma	United States	73034
57	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
58	Dr. James Webb & Associates	Tulsa	Oklahoma	United States	74133
59	Altoona Center for Clinical Research - Research	Duncansville	Pennsylvania	United States	16635
60	PA Regional Center for Arthritis & Osteoporosis Research	Wyomissing	Pennsylvania	United States	19610
61	Palmetto Clinical Research	Summerville	South Carolina	United States	29485
62	The Endocrine Clinic PC	Memphis	Tennessee	United States	38119
63	Inquest Clinical Research	Baytown	Texas	United States	77521
64	Advanced Clinical Research-Be Well MD	Cedar Park	Texas	United States	78613
65	Research Institute of Dallas	Dallas	Texas	United States	75231
66	Valley Institute of Research - General Practice	Harlingen	Texas	United States	78550
67	Valley Institute of Research	Harlingen	Texas	United States	78550
68	Biopharma Informatic LLC	Houston	Texas	United States	77084
69	Quality Research Inc.	San Antonio	Texas	United States	78209
70	BFHC Research	San Antonio	Texas	United States	78249
71	Advanced Clinical Research (ACR) - Jordan Valley	West Jordan	Utah	United States	84088
72	Endocrinology & Diabetes Center	Chesapeake	Virginia	United States	23321
73	Western Branch Center for Women	Chesapeake	Virginia	United States	23321
74	Puget Sound Osteoporosis Center	Renton	Washington	United States	98057
75	Seattle Rheumatology Associates	Seattle	Washington	United States	98122
76	Arthritis Northwest Rheumatology, PLLC	Spokane	Washington	United States	99204
77	University of Wisconsin Madison	Madison	Wisconsin	United States	53705
78	Center for Clinical and Basic Research A/S	Aalborg		Denmark
79	Center for Clinical and Basic Research A/S	Ballerup		Denmark
80	Center for Clinical and Basic Research A/S	Vejle		Denmark
81	Synexus Magyarország Egészségügyi Szolgáltató Kft. - Budapest	Budapest		Hungary
82	Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen	Debrecen		Hungary
83	Synexus Magyarország Egészségügyi Szolgáltató Kft. - Gyula	Gyula		Hungary
84	Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház	Nyíregyháza		Hungary
85	Synexus Magyarország Egészségügyi Szolgáltató Kft. - Zalaegerszeg	Zalaegerszeg		Hungary
86	Synexus Polska Sp. Z o.o. Oddział w Częstochowie	Częstochowa		Poland
87	Synexus Polska Sp. z o.o. Oddzial w Gdansku	Gdansk		Poland
88	Synexus Polska Sp. z o.o. Oddzial w Gdyni	Gdynia		Poland
89	Synexus Polska Sp. z o.o. Oddzial w Katowicach	Katowice		Poland
90	Krakowskie Centrum Medyczne Sp. z o.o.	Krakow		Poland
91	Specjalistyczny Osrodek Medycyny Wieku Dojrzałego Sp zo.o.	Lodz		Poland
92	Synexus Polska Sp. Z o.o. Oddział w Lodzi	Lodz		Poland
93	Synexus Polska Sp. z o.o. Oddzial w Poznaniu	Poznan		Poland
94	Specjalistyczny Ośrodek Medycyny Wieku Dojrzałego Sp. z o.o	Warszawa		Poland
95	Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa		Poland
96	Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroclaw		Poland
97	Mindful Rheumatix & Medical Research Group	San Juan		Puerto Rico	00918