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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
Sponsor:
Information provided by (Responsible Party):
Radius Health, Inc.

Tracking Information
First Submitted Date  ICMJE April 26, 2011
First Posted Date  ICMJE April 27, 2011
Results First Submitted Date  ICMJE October 25, 2016
Results First Posted Date  ICMJE March 1, 2017
Last Update Posted Date March 1, 2017
Study Start Date  ICMJE April 2011
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
Number of Participants With New Vertebral Fractures at 18 Months [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2011)
New vertebral fractures [ Time Frame: 18 months ]
Number of BA058-treated patients showing new vertebral fractures by X-ray at End-of-Treatment when compared to Placebo in postmenopausal women
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2011)
  • Bone mineral density of lumbar spine, hip, and femoral neck [ Time Frame: 18 months ]
    Efficacy of BA058 on lumbar spine, hip, and femoral neck bone mineral density at End-of-Treatment when compared to teriparatide in postmenopausal women
  • Non-vertebral fractures [ Time Frame: 18 months ]
    Efficacy of BA058 on incidence of non-vertebral fractures at End-of-Treatment when compared to Placebo in postmenopausal women
  • Number of hypercalcemic events [ Time Frame: 18 months ]
    Number of hypercalcemic events in BA058 treated patients at End-of-Treatment when compared to teriparatide in postmenopausal women
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis
  • Postmenopausal Osteoporosis
Intervention  ICMJE
  • Drug: Placebo
    Placebo 0 mcg subcutaneous daily
  • Drug: BA058 80 mcg
    BA058 80 mcg subcutaneous daily
    Other Name: abaloparatide, Abaloparatide-SC
  • Drug: teriparatide
    teriparatide 20 mcg subcutaneous daily
    Other Names:
    • Forteo
    • Forsteo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo identical in appearance to BA058 study drug
    Intervention: Drug: Placebo
  • Experimental: BA058 80 mcg (abaloparatide)
    Intervention: Drug: BA058 80 mcg
  • Active Comparator: teriparatide
    Blinded until after randomization, then open-label
    Intervention: Drug: teriparatide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2015)
2463
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2011)
2400
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Czech Republic,   Denmark,   Estonia,   Hong Kong,   Lithuania,   Poland,   Romania,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01343004
Other Study ID Numbers  ICMJE BA058-05-003
ACTIVE Trial ( Other Identifier: Radius Health, Inc. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radius Health, Inc.
Study Sponsor  ICMJE Radius Health, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Radius Health, Inc. Radius Health, Inc.
PRS Account Radius Health, Inc.
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP