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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542425
• Other study ID #: BA058-05-002
• Status: Completed
• Phase: Phase 2
• First received: October 10, 2007
• Last updated: September 27, 2017
• Start date: April 2007
• Est. completion date: June 2009

Study information

• Verified date: September 2017
• Source: Radius Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• teriparatide
teriparatide 20 µg subcutaneous daily
• Placebo
Placebo subcutaneous daily
• BA058 20 µg
BA058 20 µg subcutaneous daily
• BA058 40 µg
BA058 40 µg subcutaneous daily
• BA058 80 µg
BA058 80 µg subcutaneous daily

Locations

Country	Name	City	State
United States	Radius Health, Inc.	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Radius Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Marker of Bone Metabolism, PINP	PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.	6 months
Primary	Change in Bone Mineral Density, Total Spine.	Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.	6 months
Secondary	Change in Bone Mineral Density, Femoral Neck.	Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.	6 months
Secondary	Change in Bone Mineral Density, Total Hip.	Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.	6 months
Secondary	Change in Bone Mineral Density, Total Spine.	Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.	12 months