Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis

Phase 2

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Placebo; Drug: BA058 80 µg; Drug: BA058 20 µg; Drug: BA058 40 µg; Drug: teriparatide

• Registration Number: NCT00542425
• Lead Sponsor: Radius Health, Inc.

Brief Summary

The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.

Detailed Description

This is a randomized, parallel-group, multi-center, dose-finding study to evaluate the effects of BA058 in the treatment of otherwise healthy postmenopausal women with osteoporosis.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-10-10
• Study First Submitted QC: 2007-10-10
• Study First Posted: 2007-10-11
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2010-06-30
• Results First Submitted QC: 2010-06-30
• Results First Posted: 2010-07-29
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 222

Inclusion Criteria

• The patient has a bone mineral density T-score ≤ 2.5 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA). Women with a bone mineral density T-score of 2.0 or lower and a prior low-trauma forearm, humerus, vertebral, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years, or who have an additional risk factor such as age 65 or greater or a strong maternal history of osteoporosis defined as a fracture related to osteoporosis or osteoporosis itself as determined by BMD criteria, are also study candidates.
• The patient is in good general health as determined by medical history and physical examination and is without evidence of clinically significant abnormality in the opinion of the Investigator.

Primary

Exclusion Criteria

• History of bone disorders (e.g., Paget's disease) other than postmenopausal osteoporosis.
• Prior treatment with approved or as yet unapproved bone-acting investigational agents.
• History of carcinoma, nephrolithiasis or urolithiasis within the past five years or osteosarcoma at any time.
• History of radiotherapy (radiation therapy).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BA058 80 µg	BA058 80 µg	-
BA058 20 µg	BA058 20 µg	-
BA058 40 µg	BA058 40 µg	-
teriparatide	teriparatide	-

Primary Outcome Measures

Name	Time	Method
Change in Marker of Bone Metabolism, PINP	6 months	PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.
Change in Bone Mineral Density, Total Spine.	6 months	Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.

Secondary Outcome Measures

Name	Time	Method
Change in Bone Mineral Density, Femoral Neck.	6 months	Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.
Change in Bone Mineral Density, Total Hip.	6 months	Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.
Change in Bone Mineral Density, Total Spine.	12 months	Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.

Trial Locations

Locations (1)

Radius Health, Inc.; 🇺🇸 Cambridge, Massachusetts, United States