Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) 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: Completed

Sponsored by: Radius Health, Inc.

Official(s) and/or principal investigator(s):
Radius Health, Inc., Study Director, Affiliation: Radius Health, Inc.

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.

Official title: A Randomized, Double-blind, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) 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 (abaloparatide) 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 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

Buenos Aires, Argentina

Brasilia, Brazil

Curitiba, Brazil

Rio de Janeiro, Brazil

Sao Paolo, Brazil

Vitoria, Brazil

Brno, Czech Republic

Pardubice, Czech Republic

Prague, Czech Republic

Aalborg, Denmark

Ballerup, Denmark

Vejle, Denmark

Tallinn, Estonia

Tartu, Estonia

Hong Kong, Hong Kong

Vilnius, Lithuania

Bialystok, Poland

Katowice, Poland

Kielce, Poland

Lodz, Poland

Warszaw, Poland

Zgierz, Poland

Bucharest, Romania

Lakewood, Colorado, United States

Miami, Florida, United States

N. Miami, Florida, United States

Atlanta, Georgia, United States

Bethesda, Maryland, United States

Starting date: April 2011
Last updated: January 26, 2015