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

This study has been completed.
Sponsor:
Information provided by:
Radius Health, Inc.
ClinicalTrials.gov Identifier:
NCT00542425
First received: October 10, 2007
Last updated: June 30, 2010
Last verified: June 2010

October 10, 2007
June 30, 2010
April 2007
June 2009   (final data collection date for primary outcome measure)
  • Change in Marker of Bone Metabolism, PINP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.
  • Change in markers of bone metabolism. [ Time Frame: 6 months ]
  • Change in bone mineral density. [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00542425 on ClinicalTrials.gov Archive Site
  • Change in Bone Mineral Density, Femoral Neck. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.
  • Change in Bone Mineral Density, Total Hip. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.
Safety and tolerability. [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
A Randomized, Parallel-Group, Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Osteoporosis
  • Drug: teriparatide
    teriparatide 20 µg subcutaneous daily
    Other Name: PTH
  • 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
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: BA058 20 µg
    Intervention: Drug: BA058 20 µg
  • Experimental: BA058 40 µg
    Intervention: Drug: BA058 40 µg
  • Experimental: BA058 80 µg
    Intervention: Drug: BA058 80 µg
  • Active Comparator: teriparatide
    Intervention: Drug: teriparatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
June 2009
June 2009   (final data collection date for primary outcome measure)

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).
Female
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00542425
BA058-05-002
No
Program Director, Radius Health, Inc.
Radius Health, Inc.
Not Provided
Study Director: Medical Director Radius Health, Inc.
Radius Health, Inc.
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP