Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: abaloparatide; abaloparatide solid microstructured transdermal system
Intervention description: Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.; Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto a sMTS array for transdermal administration of abaloparatide.
Intervention MeSH terms: Abaloparatide; Parathyroid Hormone-Related Protein
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 511.0
Sex: Female
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteoporosis; transdermal delivery; microneedle; solid microstructured transdermal system; abaloparatide-sMTS; patch; abaloparatide; fracture; bone loss; TYMLOS®

Summary:

      A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured
      transdermal system (sMTS) with abaloparatide-subcutaneous (SC).
    

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