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

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

teriparatide

Placebo

BA058 20 µg

BA058 40 µg

BA058 80 µg

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, postmenopausal, bone loss

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Primary 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).

Sites / Locations

Radius Health, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Placebo

BA058 20 µg

BA058 40 µg

BA058 80 µg

teriparatide

Arm Description

Outcomes

Primary Outcome Measures

Change in Marker of Bone Metabolism, PINP

PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.

Change in Bone Mineral Density, Total Spine.

Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.

Secondary Outcome Measures

Change in Bone Mineral Density, Femoral Neck.

Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.

Change in Bone Mineral Density, Total Hip.

Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.

Change in Bone Mineral Density, Total Spine.

Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.

Full Information

NCT ID

NCT00542425

First Posted

October 10, 2007

Last Updated

September 27, 2017

Sponsor

Radius Health, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00542425

Brief Title

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

Official Title

A Randomized, Parallel-Group, Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radius Health, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

osteoporosis, postmenopausal, bone loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

222 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

BA058 20 µg

Arm Type

Experimental

Arm Title

BA058 40 µg

Arm Type

Experimental

Arm Title

BA058 80 µg

Arm Type

Experimental

Arm Title

teriparatide

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

teriparatide

Other Intervention Name(s)

PTH

Intervention Description

teriparatide 20 µg subcutaneous daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo subcutaneous daily

Intervention Type

Drug

Intervention Name(s)

BA058 20 µg

Intervention Description

BA058 20 µg subcutaneous daily

Intervention Type

Drug

Intervention Name(s)

BA058 40 µg

Intervention Description

BA058 40 µg subcutaneous daily

Intervention Type

Drug

Intervention Name(s)

BA058 80 µg

Intervention Description

BA058 80 µg subcutaneous daily

Primary Outcome Measure Information:

Title

Change in Marker of Bone Metabolism, PINP

Description

PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.

Time Frame

6 months

Title

Change in Bone Mineral Density, Total Spine.

Description

Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change in Bone Mineral Density, Femoral Neck.

Description

Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.

Time Frame

6 months

Title

Change in Bone Mineral Density, Total Hip.

Description

Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.

Time Frame

6 months

Title

Change in Bone Mineral Density, Total Spine.

Description

Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Primary 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Radius Health, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Radius Health, Inc.

City

Cambridge

State/Province

Massachusetts

ZIP/Postal Code

02139

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25393645

Citation

Leder BZ, O'Dea LS, Zanchetta JR, Kumar P, Banks K, McKay K, Lyttle CR, Hattersley G. Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2015 Feb;100(2):697-706. doi: 10.1210/jc.2014-3718. Epub 2014 Nov 13.

Results Reference

derived

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

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