Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

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 thelumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) andradiological evidence of 2 or more mild or one or more moderate lumbar or thoracicvertebral 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 beenrolled. Women older than 65 who do not meet the fracture criteria may also beenrolled 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), serumphosphorus 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 (suchas Paget's disease) or a diagnosis of cancer within the last 5 years (with theexception of basal cell or squamous cancer of the skin)

• History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes orany chronic or recurrent diseases or disturbances that would interfere with theinterpretation 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 fiveyears or treatment with androgens, anabolic steroids, corticosteroids or selectiveestrogen receptor modulators within the past 12 months (except hormone replacementtherapy)

• Prior treatment with an investigational drug within the past 12 months

• History of nephrolithiasis or urolithiasis within the past five years, or history ofosteosarcoma at any time