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

January 10, 2017 updated by: Radius Health, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

2463

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • United States
    • Colorado
      • Lakewood, Colorado, United States
    • Florida
      • Miami, Florida, United States
      • N. Miami, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Maryland
      • Bethesda, Maryland, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • abaloparatide, Abaloparatide-SC
Active Comparator: teriparatide
Blinded until after randomization, then open-label
Drug: teriparatide
teriparatide 20 mcg subcutaneous daily
Other Names:
  • Forteo
  • Forsteo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With New Vertebral Fractures at 18 Months
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months
Time Frame: Basline and 18 months
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
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
Baseline and 18 months
Number of Participants With Non-vertebral Fractures at 18 Months
Time Frame: 18 months
18 months
Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radius Health, Inc.

Investigators

  • Study Director: Radius Health, Inc., Radius Health, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 26, 2011

First Submitted That Met QC Criteria

April 26, 2011

First Posted (Estimate)

April 27, 2011

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA058-05-003
  • ACTIVE Trial (Other Identifier: Radius Health, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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