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

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ClinicalTrials.gov Identifier: NCT04064411
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Radius Health, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 474 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: parallel 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 : August 5, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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 Name: 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 Name: TYMLOS®; BA058




Primary Outcome Measures :
  1. Percent change from baseline in lumbar spine BMD at 12 months [ Time Frame: 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 :
  1. Percent change from baseline in total hip BMD at 12 months [ Time Frame: 12 months ]
    percent change from baseline in BMD of total hip using DXA results; abaloparatide-sMTS compared with abaloparatide-SC

  2. Percent change from baseline in femoral neck BMD at 12 months [ Time Frame: 12 months ]
    percent change from baseline in BMD of femoral neck using DXA results; abaloparatide-sMTS compared with abaloparatide-SC



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064411


Contacts
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Contact: Radius Health Inc 617-551-4002 BA058-05-021@radiuspharm.com
Contact: Clinical Operations 617-551-4000 clinopsionfo@radiuspharm.com

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Sponsors and Collaborators
Radius Health, Inc.

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Responsible Party: Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT04064411     History of Changes
Other Study ID Numbers: BA058-05-021
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radius Health, Inc.:
Osteoporosis
transdermal delivery
microneedle
solid microstructured transdermal system
abaloparatide-sMTS
patch
abaloparatide
fracture
bone loss
TYMLOS®
Additional relevant MeSH terms:
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Abaloparatide
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Parathyroid Hormone-Related Protein
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents