Purpose

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

Condition

Eligibility

Eligible Ages
Between 50 Years and 85 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
parallel assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
outcomes assessor

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Alabama Hospital at Birmingham
Birmingham, Alabama 35294
Contact:
Giovanna Rosas
205-934-1444
grosas@uabmc.edu

More Details

Status
Recruiting
Sponsor
Radius Health, Inc.

Study Contact

Radius Health Inc
617-551-4002
BA058-05-021@radiuspharm.com

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.