A Randomized, Double-blind, Placebo-controlled, Comparative Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of BA058 for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women with Severe Osteoporosis and at Risk of Fracture

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 2400

Inclusion 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 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
oPostmenopausal 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, ECG and medical history, with a body mass index (BMI) of 18.5 to 33
•Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

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)
•History of radiotherapy - other than radioiodine therapy
•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 nephrolithiasis or urolithiasis within the past five years, or history of osteosarcoma at any time
•History of thyroid disorders, 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 PTH or PTHrP
•Prior treatment with bone acting drugs within the past five years
•Prior treatment with androgens, anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months
•Prior treatment with an investigational drug within the past 12 months
•Hepatitis B, Hepatitis C, HIV-1 or HIV-2 positive

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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