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

Phase 3

Completed

• Conditions: Osteoporosis; Postmenopausal Osteoporosis
• Interventions: Drug: teriparatide; Drug: Placebo; Drug: BA058 80 mcg

• Registration Number: NCT01343004
• Lead Sponsor: Radius Health, Inc.

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 Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-04-26
• Study First Posted: 2011-04-27
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2016-10-25
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-10
• Last Update Submitted: 2017-01-10
• Results First Posted: 2017-03-01
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2463

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
teriparatide	teriparatide	Blinded until after randomization, then open-label
Placebo	Placebo	Placebo identical in appearance to BA058 study drug
BA058 80 mcg (abaloparatide)	BA058 80 mcg	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With New Vertebral Fractures at 18 Months	18 months

Secondary Outcome Measures

Name	Time	Method
Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18	Baseline and 18 months
Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months	18 months
Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18	Baseline and 18 months
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months	Basline and 18 months
Number of Participants With Non-vertebral Fractures at 18 Months	18 months