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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.

Study Description
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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.

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01343004


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Sponsors and Collaborators
Radius Health, Inc.
Investigators
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Study Director: Radius Health, Inc. Radius Health, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT01343004     History of Changes
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.:
BA058
abaloparatide
Abaloparatide-SC
osteoporosis
 postmenopausal
bone loss
ACTIVE
fracture
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
 Teriparatide
Abaloparatide
Parathyroid Hormone-Related Protein
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents