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NCT00542425·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

222

Locations

1

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

DRUG

teriparatide

teriparatide 20 µg subcutaneous daily

DRUG

Placebo

Placebo subcutaneous daily

DRUG

BA058 20 µg

BA058 20 µg subcutaneous daily

DRUG

BA058 40 µg

BA058 40 µg subcutaneous daily

DRUG

BA058 80 µg

BA058 80 µg subcutaneous daily

Timeline

From registration to results.

  1. First posted

    Oct 11, 2007

  2. Study start

    Apr 2007

  3. Primary completion

    Jun 2009

  4. Study completion

    Jun 2009

  5. Results posted

    Jul 29, 2010

  6. Registry updated

    Oct 30, 2017

Outcomes

What the study measures.

Primary outcomes

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.

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.

Secondary outcomes

Change in Bone Mineral Density, Femoral Neck.

Time frame · 6 months

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

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.

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.

Eligibility

Who can take part.

Minimum age
55 Years
Maximum age
85 Years
Sex
FEMALE
Healthy volunteers
No

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Radius Health, Inc.

Cambridge, Massachusetts, United States

Related trials

More studies on Abaloparatide.

Related PeptideStat pages

Put the record in context.

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