None listed
Conditions
Interventions
SUBJECTS WILL BE OFFERED OPEN-LABEL DENOSUMAB AT A DOSE OF 120 MG SC Q4W UNTIL DENOSUMAB IS APPROVED AND AVAILABLE FOR SALE. AMGEN MAY END THIS STUDY PRIOR TO DENOSUMAB BEING APPROVED AND AVAILABLE FO
Sponsors
AMGEN INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. SUBJECTS WAS PREVIOUSLY ENROLLED IN A DENOSUMAB PHASE 3 STUDY AND PARTICIPATED IN THE OPEN-LABEL EXTENSION PORTION OF THAT STUDY. 2. SUBJECT OR SUBJECT´S LEGALLY ACCEPTABLE REPRESENTATIVE HAS PROVIDED INFORMED CONSENT.
Exclusion criteria
Exclusion criteria: 1. SUBJECT IS OF CHILD BEARING POTENTIAL AND PLANNING TO BECOME PREGNANT WITHIN 7 MONTHS AFTER THE END OF TREATMENT. 2. SUBJECT IS OF CHILD BEARING POTENTIAL AND IS NOT WILLING TO USE, IN COMBINATION WITH HER PARTNER FEMALE, TWO HIGHLY EFFECTIVE METHOD OF CONTRACEPTION DURING TREATMENT AND FOR 7 MONTHS AFTER THE END OF TREATMENT 3. SUBJECT HAS KNOWN SENSITIVITY TO ANY OF THE PRODUCTS TO BE ADMINISTERED DURING DOSING. 4. SUBJECT WILL NOT BE AVAILABLE FOR PROTOCOL-REQUIRED STUDY VISITS OR PROCEDURES, TO THE BEST OF THE SUBJECT AND INVESTIGATOR´S KNOWLEDGE. 5. SUBJECT HAS ANY KIND OF DISORDER THAT, IN THE OPINION OF THE INVESTIGATOR, MAY COMPROMISE THE ABILITY OF THE SUBJECT TO GIVE WRITTEN INFORMED CONSENT AND/OR TO COMPLY WITH ALL REQUIRED STUDY PROCEDURES.
Countries
Argentina, Austria, Belgium, Brazil, Czech Republic, France, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Panama, Peru, Poland, Russian Federation, South Africa, Spain, Ukraine
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed