An Observational follow-up study to Protocol 018
- Conditions
- OsteoporosisMedDRA version: 14.1 Level: PT Classification code 10031282 Term: Osteoporosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2013-001526-26-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 16071
In order to be eligible for participation in this trial, the subject must:
1. Have been randomized into Protocol 018
2. Have taken at least 1 dose of blinded study medication
3. Have discontinued from Protocol 018 base study prior to study close-out OR have completed the base study of Protocol 018 and did not continue into the 1st extension of Protocol 018 OR have discontinued the 1st extension study (Protocol 018-10/Protocol 018-05) prior to reaching the open-label portion of the study OR have discontinued the amended 1st extension study (Protocol 018-06) prior to reaching the open-label period of the study and did not consent to continue follow-up clinic visits and study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6000
The subject must be excluded from participating in the trial if the subject:
1. Had her Protocol 018 treatment group assignment unblinded, prior to the open-label period
2. Has discontinued treatment after she entered into the open-label period
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method