Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women
Information source: Radius Health, Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
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.
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.
Clinical Details
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 neckNon-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.
Eligibility
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
Locations and Contacts
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
Additional Information
Starting date: April 2011
Last updated: January 26, 2015
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