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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.
October 10, 2007
October 11, 2007
June 30, 2010
July 29, 2010
October 30, 2017
April 2007
June 2009   (Final data collection date for primary outcome measure)
  • 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.
  • 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 ]
    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.
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Leder BZ, O'Dea LS, Zanchetta JR, Kumar P, Banks K, McKay K, Lyttle CR, Hattersley G. Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2015 Feb;100(2):697-706. doi: 10.1210/jc.2014-3718. Epub 2014 Nov 13.

*   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).
Sexes Eligible for Study: Female
55 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00542425
BA058-05-002
No
Not Provided
Not Provided
Radius Health, Inc.
Radius Health, Inc.
Not Provided
Study Director: Medical Director Radius Health, Inc.
Radius Health, Inc.
September 2017

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