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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:
ClinicalTrials.gov Identifier:
NCT00542425
First Posted: October 11, 2007
Last Update Posted: October 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Radius Health, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


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

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT00542425     History of Changes
Other Study ID Numbers: BA058-05-002
First Submitted: October 10, 2007
First Posted: October 11, 2007
Results First Submitted: June 30, 2010
Results First Posted: July 29, 2010
Last Update Posted: October 30, 2017
Last Verified: September 2017

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

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