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

NCT ID: NCT00542425

Last Updated: 2017-10-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoporosis

Keywords

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osteoporosis postmenopausal bone loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo subcutaneous daily

BA058 20 µg

Group Type EXPERIMENTAL

BA058 20 µg

Intervention Type DRUG

BA058 20 µg subcutaneous daily

BA058 40 µg

Group Type EXPERIMENTAL

BA058 40 µg

Intervention Type DRUG

BA058 40 µg subcutaneous daily

BA058 80 µg

Group Type EXPERIMENTAL

BA058 80 µg

Intervention Type DRUG

BA058 80 µg subcutaneous daily

teriparatide

Group Type ACTIVE_COMPARATOR

teriparatide

Intervention Type DRUG

teriparatide 20 µg subcutaneous daily

Interventions

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teriparatide

teriparatide 20 µg subcutaneous daily

Intervention Type DRUG

Placebo

Placebo subcutaneous daily

Intervention Type DRUG

BA058 20 µg

BA058 20 µg subcutaneous daily

Intervention Type DRUG

BA058 40 µg

BA058 40 µg subcutaneous daily

Intervention Type DRUG

BA058 80 µg

BA058 80 µg subcutaneous daily

Intervention Type DRUG

Other Intervention Names

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PTH

Eligibility Criteria

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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).
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Radius Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Radius Health, Inc.

Locations

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Radius Health, Inc.

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25393645 (View on PubMed)

Other Identifiers

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BA058-05-002

Identifier Type: -

Identifier Source: org_study_id