Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women (ACTIVE)
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ClinicalTrials.gov Identifier: NCT01343004 |
Recruitment Status :
Completed
First Posted : April 27, 2011
Results First Posted : March 1, 2017
Last Update Posted : March 1, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis Postmenopausal Osteoporosis | Drug: Placebo Drug: BA058 80 mcg Drug: teriparatide | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2463 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | April 2011 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | October 2014 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo identical in appearance to BA058 study drug
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Drug: Placebo
Placebo 0 mcg subcutaneous daily |
Experimental: BA058 80 mcg (abaloparatide) |
Drug: BA058 80 mcg
BA058 80 mcg subcutaneous daily
Other Name: abaloparatide, Abaloparatide-SC |
Active Comparator: teriparatide
Blinded until after randomization, then open-label
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Drug: teriparatide
teriparatide 20 mcg subcutaneous daily
Other Names:
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- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343004
United States, Colorado | |
Lakewood, Colorado, United States | |
United States, Florida | |
Miami, Florida, United States | |
N. Miami, Florida, United States | |
United States, Georgia | |
Atlanta, Georgia, United States | |
United States, Maryland | |
Bethesda, Maryland, United States | |
Argentina | |
Buenos Aires, Argentina | |
Brazil | |
Brasilia, Brazil | |
Curitiba, Brazil | |
Rio de Janeiro, Brazil | |
Sao Paolo, Brazil | |
Vitoria, Brazil | |
Czech Republic | |
Brno, Czech Republic | |
Pardubice, Czech Republic | |
Prague, Czech Republic | |
Denmark | |
Aalborg, Denmark | |
Ballerup, Denmark | |
Vejle, Denmark | |
Estonia | |
Tallinn, Estonia | |
Tartu, Estonia | |
Hong Kong | |
Hong Kong, Hong Kong | |
Lithuania | |
Vilnius, Lithuania | |
Poland | |
Bialystok, Poland | |
Katowice, Poland | |
Kielce, Poland | |
Lodz, Poland | |
Warszaw, Poland | |
Zgierz, Poland | |
Romania | |
Bucharest, Romania |
Study Director: | Radius Health, Inc. | Radius Health, Inc. |
Responsible Party: | Radius Health, Inc. |
ClinicalTrials.gov Identifier: | NCT01343004 |
Other Study ID Numbers: |
BA058-05-003 ACTIVE Trial ( Other Identifier: Radius Health, Inc. ) |
First Posted: | April 27, 2011 Key Record Dates |
Results First Posted: | March 1, 2017 |
Last Update Posted: | March 1, 2017 |
Last Verified: | January 2017 |
BA058 abaloparatide Abaloparatide-SC osteoporosis |
postmenopausal bone loss ACTIVE fracture |
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |
Teriparatide Abaloparatide Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Bone Density Conservation Agents |