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

Phase 1

• Conditions: Osteoporosis in postmenopausal women; MedDRA version: 18.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-002216-10-CZ
• Lead Sponsor: Radius Health, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-06
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1600

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1.Subjects who were withdrawn from Study BA058-05-003 for any reason.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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified