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

Osteoporosis Clinical Trial

— ACTIVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343004
• Other study ID #: BA058-05-003
• Secondary ID: ACTIVE Trial
• Status: Completed
• Phase: Phase 3
• First received: April 26, 2011
• Last updated: January 26, 2015
• Start date: April 2011
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: Radius Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of HealthBrazil: Ministry of HealthHong Kong: Department of HealthCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyEstonia: The State Agency of MedicineLithuania: State Medicine Control Agency - Ministry of HealthPoland: Ministry of HealthRomania: National Medicines AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2463
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• Placebo
Placebo 0 mcg subcutaneous daily
• BA058 80 mcg
BA058 80 mcg subcutaneous daily
• teriparatide
teriparatide 20 mcg subcutaneous daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radius Health, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Czech Republic,  Denmark,  Estonia,  Hong Kong,  Lithuania,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New vertebral fractures	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	18 months	No
Secondary	Bone mineral density of lumbar spine, hip, and femoral neck	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	18 months	No
Secondary	Non-vertebral fractures	Efficacy of BA058 (abaloparatide) on incidence of non-vertebral fractures at End-of-Treatment when compared to Placebo in postmenopausal women	18 months	No
Secondary	Number of hypercalcemic events	Number of hypercalcemic events in BA058 (abaloparatide) treated patients at End-of-Treatment when compared to teriparatide in postmenopausal women	18 months	Yes