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Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis | Clinical Trials | Clareo Health

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

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

NCT00542425•Radius Health, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

55 - 85 years

Sex

FEMALE

Healthy Volunteers

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.

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).

Locations (1)

Radius Health, Inc.

Cambridge, Massachusetts, United States

Key Dates

Start Date

April 1, 2007

Primary Completion Date

June 1, 2009

Completion Date

June 1, 2009

Last Updated

October 30, 2017

Enrollment

222

ACTUAL participants

Conditions

Osteoporosis

Interventions

teriparatide

DRUG

Placebo

DRUG

BA058 20 µg

DRUG

BA058 40 µg

DRUG

BA058 80 µg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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