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

Radius Health

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

Treatments: Drug: BA058 80 µg; Drug: BA058 20 µg; Drug: teriparatide; Drug: BA058 40 µg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00542425

BA058-05-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 222 patients

Sex: Female

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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222 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

BA058 20 µg

Experimental group

Treatment:

Drug: BA058 20 µg

BA058 40 µg

Experimental group

Treatment:

Drug: BA058 40 µg

BA058 80 µg

Experimental group

Treatment:

Drug: BA058 80 µg

teriparatide

Active Comparator group

Treatment:

Drug: teriparatide