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

September 27, 2017 updated by: Radius Health, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

222

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02139
        • Radius Health, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo subcutaneous daily
EXPERIMENTAL: BA058 20 µg
Drug: BA058 20 µg
BA058 20 µg subcutaneous daily
EXPERIMENTAL: BA058 40 µg
Drug: BA058 40 µg
BA058 40 µg subcutaneous daily
EXPERIMENTAL: BA058 80 µg
Drug: BA058 80 µg
BA058 80 µg subcutaneous daily
ACTIVE_COMPARATOR: teriparatide
Drug: teriparatide
teriparatide 20 µg subcutaneous daily
Other Names:
  • PTH

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radius Health, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

October 10, 2007

First Submitted That Met QC Criteria

October 10, 2007

First Posted (ESTIMATE)

October 11, 2007

Study Record Updates

Last Update Posted (ACTUAL)

October 30, 2017

Last Update Submitted That Met QC Criteria

September 27, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA058-05-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoporosis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe