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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Radius Health, Inc.
ClinicalTrials.gov Identifier:
NCT01343004
First received: April 26, 2011
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Osteoporosis
Postmenopausal Osteoporosis
Drug: Placebo
Drug: BA058 80 mcg
Drug: teriparatide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Radius Health, Inc.:

Primary Outcome Measures:
  • New vertebral fractures [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Number of BA058-treated (abaloparatide-treated) patients showing new vertebral fractures by X-ray at End-of-Treatment when compared to Placebo in postmenopausal women


Secondary Outcome Measures:
  • Bone mineral density of lumbar spine, hip, and femoral neck [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Efficacy of BA058 (abaloparatide) 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 ] [ Designated as safety issue: No ]
    Efficacy of BA058 (abaloparatide) 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 ] [ Designated as safety issue: Yes ]
    Number of hypercalcemic events in BA058 (abaloparatide) treated patients at End-of-Treatment when compared to teriparatide in postmenopausal women


Estimated Enrollment: 2400
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343004

  Show 28 Study Locations
Sponsors and Collaborators
Radius Health, Inc.
Investigators
Study Director: Radius Health, Inc. Radius Health, Inc.
  More Information

No publications provided

Responsible Party: Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT01343004     History of Changes
Other Study ID Numbers: BA058-05-003, ACTIVE Trial
Study First Received: April 26, 2011
Last Updated: June 25, 2014
Health Authority: Argentina: Ministry of Health
Brazil: Ministry of Health
Hong Kong: Department of Health
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Ministry of Health
Romania: National Medicines Agency
United States: Food and Drug Administration

Keywords provided by Radius Health, Inc.:
BA058
abaloparatide
Abaloparatide-SC
osteoporosis
postmenopausal
bone loss
ACTIVE
fracture

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Fractures, Bone
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014