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

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
abaloparatide
abaloparatide solid microstructured transdermal system
Sponsored by
Radius Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Osteoporosis, transdermal delivery, microneedle, solid microstructured transdermal system, abaloparatide-sMTS, patch, abaloparatide, fracture, bone loss, TYMLOS®

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Alabama Hospital at Birmingham
  • Orthopedic Physician Alaska - Rheumatology
  • Arizona Arthritis & Rheumatology Research, PLLC - Research Center - Glendale
  • Arizona Arthritis & Rheumatology Research, PLLC
  • SunValley Arthritis Center Ltd.
  • Clinical Research Consortium
  • Arthritis & Rheumatism
  • Advanced Clinical Research (ACR) - Rancho Paseo
  • Osteoporosis Medical Center
  • Clinical Trials of St. Jude Heritage Medical Group through S
  • Allied Clinical Research
  • Marin Endocrine Care & Research, Inc.
  • St. Joseph Heritage Healthcare
  • Northern California Institute for Bone Health Inc.
  • Alta California Medical Group, Inc.
  • Lynn Institute of Denver
  • MedStar Georgetown University Hospital - Department of Obstetrics and Gynecology
  • UNC School of Medicine
  • Bay Area Arthritis And Osteoporosis
  • Clinical Research of West Florida
  • Shrock Orthopaedic Research, LLC
  • Clinical Physiology Associates, an AMR company
  • Palm Springs Research Institute
  • Health Awareness INC
  • Sweet Hope Research Specialty
  • Lakes Research, LLC
  • Global Health Research Center
  • Suncoast Research Group, LLC
  • Rheumatic Wellness Institute
  • BDA Research
  • Center for Arthritis and Rheumatic Diseases
  • Renstar Medical Research
  • West Orange Endocrinology
  • Integral Rheumatology & Immunology Specialist
  • Health Awareness, Inc.
  • Center for Advanced Research & Education
  • Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian
  • St. Luke's Clinic - Rheumatology
  • Rush University Medical Center
  • The University of Chicago Medicine
  • MediSphere Medical Research Center
  • Northeast Iowa Medical Education Foundation
  • Premier Medical Group, PSC
  • MedStar Health Center
  • Rheumatology Consultants
  • Othopaedic Associates of Michigan PC
  • Montana Medical Research, Inc
  • New Mexico Clinical Research
  • The Endocrine Group
  • Long Island Regional Arthritis & Osteoporosis Care PC
  • Physicians East, PA
  • Cape Fear Arthritis Care
  • Carteret Medical Group
  • Carolina Arthritis Associates
  • Cleveland Clinic
  • Clinical Radiology Of Oklahoma
  • Lynn Health Science Institute
  • Dr. James Webb & Associates
  • Altoona Center for Clinical Research - Research
  • PA Regional Center for Arthritis & Osteoporosis Research
  • Palmetto Clinical Research
  • The Endocrine Clinic PC
  • Inquest Clinical Research
  • Advanced Clinical Research-Be Well MD
  • Research Institute of Dallas
  • Valley Institute of Research - General Practice
  • Valley Institute of Research
  • Biopharma Informatic LLC
  • Quality Research Inc.
  • BFHC Research
  • Advanced Clinical Research (ACR) - Jordan Valley
  • Endocrinology & Diabetes Center
  • Western Branch Center for Women
  • Puget Sound Osteoporosis Center
  • Seattle Rheumatology Associates
  • Arthritis Northwest Rheumatology, PLLC
  • University of Wisconsin Madison
  • Center for Clinical and Basic Research A/S
  • Center for Clinical and Basic Research A/S
  • Center for Clinical and Basic Research A/S
  • Synexus Magyarország Egészségügyi Szolgáltató Kft. - Budapest
  • Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen
  • Synexus Magyarország Egészségügyi Szolgáltató Kft. - Gyula
  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
  • Synexus Magyarország Egészségügyi Szolgáltató Kft. - Zalaegerszeg
  • Synexus Polska Sp. Z o.o. Oddział w Częstochowie
  • Synexus Polska Sp. z o.o. Oddzial w Gdansku
  • Synexus Polska Sp. z o.o. Oddzial w Gdyni
  • Synexus Polska Sp. z o.o. Oddzial w Katowicach
  • Krakowskie Centrum Medyczne Sp. z o.o.
  • Specjalistyczny Osrodek Medycyny Wieku Dojrzałego Sp zo.o.
  • Synexus Polska Sp. Z o.o. Oddział w Lodzi
  • Synexus Polska Sp. z o.o. Oddzial w Poznaniu
  • Specjalistyczny Ośrodek Medycyny Wieku Dojrzałego Sp. z o.o
  • Synexus Polska Sp. z o.o. Oddzial w Warszawie
  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
  • Mindful Rheumatix & Medical Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

abaloparatide-SC

abaloparatide-sMTS

Arm 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.

Abaloparatide-sMTS 300 mcg applied to the thigh for 5 minutes once daily for 12 months.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Lumbar Spine BMD at Month 12
Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory.

Secondary Outcome Measures

Percent Change From Baseline in Total Hip BMD at Month 12
Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory.
Percent Change From Baseline in Femoral Neck BMD at Month 12
Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory.

Full Information

First Posted
August 19, 2019
Last Updated
February 14, 2023
Sponsor
Radius Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04064411
Brief Title
Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
October 5, 2021 (Actual)
Study Completion Date
November 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radius Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured transdermal system (sMTS) with abaloparatide-subcutaneous (SC).
Detailed Description
This study aims to evaluate the non-inferiority of abaloparatide-sMTS 300 micrograms (mcg) compared to abaloparatide-SC 80 mcg 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
Keywords
Osteoporosis, transdermal delivery, microneedle, solid microstructured transdermal system, abaloparatide-sMTS, patch, abaloparatide, fracture, bone loss, TYMLOS®

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
511 (Actual)

8. Arms, Groups, and Interventions

Arm Title
abaloparatide-SC
Arm Type
Active Comparator
Arm 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.
Arm Title
abaloparatide-sMTS
Arm Type
Experimental
Arm Description
Abaloparatide-sMTS 300 mcg applied to the thigh for 5 minutes once daily for 12 months.
Intervention Type
Combination Product
Intervention Name(s)
abaloparatide
Other Intervention Name(s)
TYMLOS®, BA058, abaloparatide-SC
Intervention Description
Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.
Intervention Type
Combination Product
Intervention Name(s)
abaloparatide solid microstructured transdermal system
Other Intervention Name(s)
BA058, abaloparatide-transdermal
Intervention Description
Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto a sMTS array for transdermal administration of abaloparatide.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Description
Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory.
Time Frame
Baseline, Month 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Total Hip BMD at Month 12
Description
Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory.
Time Frame
Baseline, Month 12
Title
Percent Change From Baseline in Femoral Neck BMD at Month 12
Description
Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory.
Time Frame
Baseline, Month 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy ambulatory female from 50 to 85 years of age (inclusive) with postmenopausal osteoporosis Participants 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 dual energy x-ray absorptiometry (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. Participants older than 65 years with BMD T score ≤ -2.0 and > -5.0 who meet the fracture criteria may be enrolled Participants 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 kilograms (kg)/square meters (m^2), inclusive serum calcium (albumin-corrected), parathyroid hormone (1-84), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone within the normal reference range Serum 25-hydroxyvitamin D values must be ≥ 20 nanograms (ng)/milliliters (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 intravenous (IV) bisphosphonates at any time or oral 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
Facility Information:
Facility Name
University of Alabama Hospital at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Orthopedic Physician Alaska - Rheumatology
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
354800
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC - Research Center - Glendale
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
SunValley Arthritis Center Ltd.
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Clinical Research Consortium
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Arthritis & Rheumatism
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Advanced Clinical Research (ACR) - Rancho Paseo
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Facility Name
Osteoporosis Medical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Clinical Trials of St. Jude Heritage Medical Group through S
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Allied Clinical Research
City
Gold River
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Marin Endocrine Care & Research, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Northern California Institute for Bone Health Inc.
City
Orinda
State/Province
California
ZIP/Postal Code
94563
Country
United States
Facility Name
Alta California Medical Group, Inc.
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Lynn Institute of Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
MedStar Georgetown University Hospital - Department of Obstetrics and Gynecology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
UNC School of Medicine
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Bay Area Arthritis And Osteoporosis
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Shrock Orthopaedic Research, LLC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Clinical Physiology Associates, an AMR company
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Palm Springs Research Institute
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Health Awareness INC
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Sweet Hope Research Specialty
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Lakes Research, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Global Health Research Center
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Suncoast Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Rheumatic Wellness Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
BDA Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Center for Arthritis and Rheumatic Diseases
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
West Orange Endocrinology
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Integral Rheumatology & Immunology Specialist
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Health Awareness, Inc.
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Center for Advanced Research & Education
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian
City
Boise
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
St. Luke's Clinic - Rheumatology
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
MediSphere Medical Research Center
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Northeast Iowa Medical Education Foundation
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50702
Country
United States
Facility Name
Premier Medical Group, PSC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
MedStar Health Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States
Facility Name
Rheumatology Consultants
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Othopaedic Associates of Michigan PC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Montana Medical Research, Inc
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
New Mexico Clinical Research
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
The Endocrine Group
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Long Island Regional Arthritis & Osteoporosis Care PC
City
Babylon
State/Province
New York
ZIP/Postal Code
11702
Country
United States
Facility Name
Physicians East, PA
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Cape Fear Arthritis Care
City
Leland
State/Province
North Carolina
ZIP/Postal Code
28451
Country
United States
Facility Name
Carteret Medical Group
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Carolina Arthritis Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Clinical Radiology Of Oklahoma
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Dr. James Webb & Associates
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Altoona Center for Clinical Research - Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
PA Regional Center for Arthritis & Osteoporosis Research
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Palmetto Clinical Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
The Endocrine Clinic PC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Inquest Clinical Research
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Advanced Clinical Research-Be Well MD
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Valley Institute of Research - General Practice
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Valley Institute of Research
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Biopharma Informatic LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Quality Research Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
BFHC Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Advanced Clinical Research (ACR) - Jordan Valley
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Endocrinology & Diabetes Center
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23321
Country
United States
Facility Name
Western Branch Center for Women
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23321
Country
United States
Facility Name
Puget Sound Osteoporosis Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Seattle Rheumatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Arthritis Northwest Rheumatology, PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
University of Wisconsin Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Center for Clinical and Basic Research A/S
City
Aalborg
Country
Denmark
Facility Name
Center for Clinical and Basic Research A/S
City
Ballerup
Country
Denmark
Facility Name
Center for Clinical and Basic Research A/S
City
Vejle
Country
Denmark
Facility Name
Synexus Magyarország Egészségügyi Szolgáltató Kft. - Budapest
City
Budapest
Country
Hungary
Facility Name
Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen
City
Debrecen
Country
Hungary
Facility Name
Synexus Magyarország Egészségügyi Szolgáltató Kft. - Gyula
City
Gyula
Country
Hungary
Facility Name
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
City
Nyíregyháza
Country
Hungary
Facility Name
Synexus Magyarország Egészségügyi Szolgáltató Kft. - Zalaegerszeg
City
Zalaegerszeg
Country
Hungary
Facility Name
Synexus Polska Sp. Z o.o. Oddział w Częstochowie
City
Częstochowa
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdansku
City
Gdansk
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdyni
City
Gdynia
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Katowicach
City
Katowice
Country
Poland
Facility Name
Krakowskie Centrum Medyczne Sp. z o.o.
City
Krakow
Country
Poland
Facility Name
Specjalistyczny Osrodek Medycyny Wieku Dojrzałego Sp zo.o.
City
Lodz
Country
Poland
Facility Name
Synexus Polska Sp. Z o.o. Oddział w Lodzi
City
Lodz
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
City
Poznan
Country
Poland
Facility Name
Specjalistyczny Ośrodek Medycyny Wieku Dojrzałego Sp. z o.o
City
Warszawa
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Warszawie
City
Warszawa
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
City
Wroclaw
Country
Poland
Facility Name
Mindful Rheumatix & Medical Research Group
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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