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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 : Active, not recruiting
First Posted : August 21, 2019
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Radius Health, Inc.

Tracking Information
First Submitted Date  ICMJE August 19, 2019
First Posted Date  ICMJE August 21, 2019
Last Update Posted Date April 13, 2021
Actual Study Start Date  ICMJE August 5, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis
Official Title  ICMJE 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)
Brief Summary A 12-month study to compare the efficacy and safety of abaloparatide-sMTS with abaloparatide-subcutaneous (SC)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
parallel assignment
Masking: Single (Outcomes Assessor)
Masking Description:
outcomes assessor
Primary Purpose: Treatment
Condition  ICMJE Postmenopausal Osteoporosis
Intervention  ICMJE
  • 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
  • Combination Product: abaloparatide-SC
    abaloparatide 80 μg injected into the abdomen once daily for 12 months
    Other Name: TYMLOS®; BA058
Study Arms  ICMJE
  • 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
    Intervention: Combination Product: abaloparatide solid microstructured transdermal system
  • 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
    Intervention: Combination Product: abaloparatide-SC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 19, 2019)
474
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Hungary,   Poland,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04064411
Other Study ID Numbers  ICMJE BA058-05-021
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Radius Health, Inc.
Study Sponsor  ICMJE Radius Health, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Radius Health, Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP