Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women
Condition: Osteoporosis; Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Placebo; BA058 80 mcg; teriparatide
Intervention description: Placebo 0 mcg subcutaneous daily; BA058 80 mcg subcutaneous daily; teriparatide 20 mcg subcutaneous daily
Intervention MeSH terms: Teriparatide; Abaloparatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2463.0
Sex: Female
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: BA058; abaloparatide; Abaloparatide-SC; osteoporosis; postmenopausal; bone loss; ACTIVE; fracture

Summary:

      The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid
      hormone-related peptide, is effective in preventing fractures in postmenopausal women with
      severe osteoporosis who are at risk of fractures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age
             (inclusive) with a diagnosis of osteoporosis

          -  The women are to have a bone mineral density (BMD) T score ≤ -2.5 and > -5.0 at the
             lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and
             radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic
             vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip,
             femoral, or tibial fracture within the past 5 years. Postmenopausal women older than
             65 who meet the above fracture criteria but have a T score ≤ -2.0 and > -5.0 may be
             enrolled. Women older than 65 who do not meet the fracture criteria may also be
             enrolled if their T score is ≤ -3.0 and > -5.0

          -  Normal physical exam, vital signs, electrocardiogram (ECG) and medical history

          -  Laboratory tests within the normal range including serum calcium, PTH(1-84), serum
             phosphorus and alkaline phosphatase

        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 bone mineral density
             (BMD)

          -  Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such
             as Paget's disease) or a diagnosis of cancer within the last 5 years (with the
             exception of basal cell or squamous cancer of the skin)

          -  History of thyroid, parathyroid, or adrenal disorders, 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 (PTH) or parathyroid hormone-related peptid
             (PTHrP)

          -  Prior treatment with bisphosphonates, fluoride, or strontium within the past five
             years or treatment with androgens, anabolic steroids, corticosteroids or selective
             estrogen receptor modulators within the past 12 months (except hormone replacement
             therapy)

          -  Prior treatment with an investigational drug within the past 12 months

          -  History of nephrolithiasis or urolithiasis within the past five years, or history of
             osteosarcoma at any time