DRUG
Placebo
Placebo 0 mcg subcutaneous daily
Status
Completed
Phase
Phase 3
Enrollment
2,463
Locations
28
Results
Posted
Publications
11
Study 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.
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.
Interventions
DRUG
Placebo 0 mcg subcutaneous daily
DRUG
BA058 80 mcg subcutaneous daily
DRUG
teriparatide 20 mcg subcutaneous daily
Timeline
First posted
Apr 27, 2011
Study start
Apr 2011
Primary completion
Oct 2014
Study completion
Oct 2014
Results posted
Mar 1, 2017
Registry updated
Mar 1, 2017
Outcomes
Number of Participants With New Vertebral Fractures at 18 Months
Time frame · 18 months
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months
Time frame · Basline and 18 months
Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18
Time frame · Baseline and 18 months
Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18
Time frame · Baseline and 18 months
Number of Participants With Non-vertebral Fractures at 18 Months
Time frame · 18 months
Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months
Time frame · 18 months
Eligibility
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
Study locations
Argentina · Brazil · Czechia · Denmark · Estonia · Hong Kong · Lithuania · Poland · Romania · United States. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Lakewood, Colorado, United States
Facility not named
Miami, Florida, United States
Facility not named
North Miami, Florida, United States
Facility not named
Atlanta, Georgia, United States
Facility not named
Bethesda, Maryland, United States
Facility not named
Buenos Aires, Argentina
Facility not named
Brasília, Brazil
Facility not named
Curitiba, Brazil
Facility not named
Rio de Janeiro, Brazil
Facility not named
São Paulo, Brazil
Facility not named
Vitória, Brazil
Facility not named
Brno, Czechia
Facility not named
Pardubice, Czechia
Facility not named
Prague, Czechia
Facility not named
Aalborg, Denmark
Facility not named
Ballerup Municipality, Denmark
Facility not named
Vejle, Denmark
Facility not named
Tallinn, Estonia
Facility not named
Tartu, Estonia
Facility not named
Hong Kong, Hong Kong
Facility not named
Vilnius, Lithuania
Facility not named
Bialystok, Poland
Facility not named
Katowice, Poland
Facility not named
Kielce, Poland
Publications
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