NCT00542425

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 29, 2010

Completed
Last Updated

October 30, 2017

Status Verified

September 1, 2017

Enrollment Period

2.2 years

First QC Date

October 10, 2007

Results QC Date

June 30, 2010

Last Update Submit

September 27, 2017

Conditions

Osteoporosis

Keywords

osteoporosispostmenopausalbone loss

Outcome Measures

Primary Outcomes (2)

  • Change in Marker of Bone Metabolism, PINP

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

    6 months

  • Change in Bone Mineral Density, Total Spine.

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

    6 months

Secondary Outcomes (3)

  • Change in Bone Mineral Density, Femoral Neck.

    6 months

  • Change in Bone Mineral Density, Total Hip.

    6 months

  • Change in Bone Mineral Density, Total Spine.

    12 months

Study Arms (5)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

BA058 20 µg

EXPERIMENTAL
Drug: BA058 20 µg

BA058 40 µg

EXPERIMENTAL
Drug: BA058 40 µg

BA058 80 µg

EXPERIMENTAL
Drug: BA058 80 µg

teriparatide

ACTIVE COMPARATOR
Drug: teriparatide

Interventions

teriparatideDRUG

teriparatide 20 µg subcutaneous daily

Also known as: PTH
teriparatide
PlaceboDRUG

Placebo subcutaneous daily

Placebo
BA058 20 µgDRUG

BA058 20 µg subcutaneous daily

BA058 20 µg
BA058 40 µgDRUG

BA058 40 µg subcutaneous daily

BA058 40 µg
BA058 80 µgDRUG

BA058 80 µg subcutaneous daily

BA058 80 µg

Eligibility Criteria

Age55 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radius Health, Inc.

Cambridge, Massachusetts, 02139, United States

Location

Related Publications (1)

  • 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.

    PMID: 25393645DERIVED

MeSH Terms

Conditions

OsteoporosisBone Diseases, Metabolic

Interventions

Teriparatideabaloparatide

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Program Director
Organization
Radius Health, Inc.
info@radiuspharm.com
(617) 551-4700

Study Officials

  • Medical Director

    Radius Health, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2007

First Posted

October 11, 2007

Study Start

April 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

October 30, 2017

Results First Posted

July 29, 2010

Record last verified: 2017-09

Locations

US(1)