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

• ClinicalTrials.gov Identifier: NCT00542425
• Recruitment Status: Completed
• First Posted: October 11, 2007
• Results First Posted: July 29, 2010
• Last Update Posted: October 30, 2017
• Sponsor: Radius Health, Inc.
• Information provided by (Responsible Party): Radius Health, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Osteoporosis	Drug: teriparatide; Drug: Placebo; Drug: BA058 20 µg; Drug: BA058 40 µg; Drug: BA058 80 µg	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 222 participants
• 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
• Study Start Date: April 2007
• Actual Primary Completion Date: June 2009
• Actual Study Completion Date: June 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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 :

1. Change in Bone Mineral Density, Femoral Neck. [ Time Frame: 6 months ]
   Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 85 Years (Adult, Older Adult)
• 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

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):

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.

• Responsible Party: Radius Health, Inc.
• ClinicalTrials.gov Identifier: NCT00542425
• Other Study ID Numbers: BA058-05-002
• First Posted: October 11, 2007
• 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; Abaloparatide; Parathyroid Hormone-Related Protein; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents