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

Condition(s) targeted: Osteoporosis; Postmenopausal Osteoporosis

Intervention: Placebo (Drug); BA058 80 mcg (Drug); teriparatide (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Radius Health, Inc.

Official(s) and/or principal investigator(s):
Louis St.L. O'Dea, MB BCh BAO. FRCP (C), Study Director, Affiliation: Radius Health, Inc.

Overall contact:
Louis St.L. O'Dea,, MB BCh BAO. FRCP (C), Phone: 617 551-4700, Email: info@radiuspharm.com

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

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: New vertebral fractures

Secondary outcome:

Bone mineral density of lumbar spine, hip, and femoral neck

Non-vertebral fractures

Number of hypercalcemic events

Detailed description: This is a randomized, double-blind, placebo-controlled, comparative Phase 3, multicenter international study to evaluate the efficacy and safety of BA058 80 µg in the prevention of fracture in otherwise healthy ambulatory postmenopausal women with severe osteoporosis.

Minimum age: 50 Years. Maximum age: 85 Years. Gender(s): Female.

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. 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, 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 PTH or 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

Louis St.L. O'Dea,, MB BCh BAO. FRCP (C), Phone: 617 551-4700, Email: info@radiuspharm.com

Rio de Janeiro, Brazil; Recruiting

Brno, Czech Republic; Recruiting

Pardubice, Czech Republic; Recruiting

Aalborg, Denmark; Recruiting

Ballerup, Denmark; Recruiting

Vejle, Denmark; Recruiting

Tallinn, Estonia; Recruiting

Hong Kong, Hong Kong; Recruiting

Vilnius, Lithuania; Recruiting

Warszaw, Poland; Recruiting

Bucharest, Romania; Recruiting

Starting date: April 2011
Last updated: April 26, 2011