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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
History of Changes
  Purpose

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


Condition Intervention Phase
Osteoporosis
 Drug: teriparatide
Drug: Placebo
Drug: BA058 20 µg
Drug: BA058 40 µg
Drug: BA058 80 µg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radius Health, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 222
Study Start Date: April 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo subcutaneous daily
Experimental: BA058 20 µg Drug: BA058 20 µg
BA058 20 µg subcutaneous daily
Experimental: BA058 40 µg Drug: BA058 40 µg
BA058 40 µg subcutaneous daily
Experimental: BA058 80 µg Drug: BA058 80 µg
BA058 80 µg subcutaneous daily
Active Comparator: teriparatide Drug: teriparatide
teriparatide 20 µg subcutaneous daily
Other Name: PTH

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.

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542425

Locations
United States, Massachusetts
Radius Health, Inc.
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Radius Health, Inc.
Investigators
Study Director: Medical Director Radius Health, Inc.
  More Information

No publications provided

Responsible Party: Program Director, Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT00542425     History of Changes
Other Study ID Numbers: BA058-05-002
Study First Received: October 10, 2007
Results First Received: June 30, 2010
Last Updated: June 30, 2010
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
India: Ministry of Health

Keywords provided by Radius Health, Inc.:
osteoporosis
postmenopausal
bone loss

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013