EUCTR2012-002216-10-DK
Active, not recruiting
Phase 1
An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Radius Health, Inc.
- Enrollment
- 1600
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.The subject was enrolled, randomized to BA058 Injection 80 µg/Placebo and completed 18\-months of blinded treatment within Study BA058\-05\-003\.
- •2\.The subject is no more than 40 days from last study medication administration.
- •3\.The subject has read, understood, and signed the written informed consent form for the Extension Study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 1000
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 600
Exclusion Criteria
- •1\.Subjects who were withdrawn from Study BA058\-05\-003 for any reason.
- •2\.Subjects who experienced a treatment\-related SAE during Study BA058\-05\-003\.
Outcomes
Primary Outcomes
Not specified
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