Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women (ACTIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01343004
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):
Radius Health, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Postmenopausal Osteoporosis Drug: Placebo Drug: BA058 80 mcg Drug: teriparatide Phase 3

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo identical in appearance to BA058 study drug
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
Drug: teriparatide
teriparatide 20 mcg subcutaneous daily
Other Names:
  • Forteo
  • Forsteo

Primary Outcome Measures :
  1. Number of Participants With New Vertebral Fractures at 18 Months [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months [ Time Frame: Basline and 18 months ]
  2. Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18 [ Time Frame: Baseline and 18 months ]
  3. Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18 [ Time Frame: Baseline and 18 months ]
  4. Number of Participants With Non-vertebral Fractures at 18 Months [ Time Frame: 18 months ]
  5. Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months [ Time Frame: 18 months ]

Information from the National Library of Medicine

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.

Layout table for eligibility information
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01343004

Layout table for location information
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
Buenos Aires, Argentina
Brasilia, Brazil
Curitiba, Brazil
Rio de Janeiro, Brazil
Sao Paolo, Brazil
Vitoria, Brazil
Czech Republic
Brno, Czech Republic
Pardubice, Czech Republic
Prague, Czech Republic
Aalborg, Denmark
Ballerup, Denmark
Vejle, Denmark
Tallinn, Estonia
Tartu, Estonia
Hong Kong
Hong Kong, Hong Kong
Vilnius, Lithuania
Bialystok, Poland
Katowice, Poland
Kielce, Poland
Lodz, Poland
Warszaw, Poland
Zgierz, Poland
Bucharest, Romania
Sponsors and Collaborators
Radius Health, Inc.
Layout table for investigator information
Study Director: Radius Health, Inc. Radius Health, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Radius Health, Inc. 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
Keywords provided by Radius Health, Inc.:
bone loss
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents