None listed
Conditions
Interventions
THE STUDY IS DESIGNED TO EVALUATE IF AMG 785 TREATMENT FOR 12 MONTHS FOLLOWED BY ALN TREATMENT, COMPARED WITH ALN TREATMENT ALONE, IS EFFECTIVE IN REDUCING THE INCIDENCE OF CLINICAL FRACTURE (NONVERTE
75 YEARS). SUBJECTS WILL ALSO RECEIVE MATCHED PLACEBO FOR EITHER ALN OR AMG 785.
AFTER THE INITIAL 12-MONTH STUDY PERIOD, SUBJECTS WILL RECEIVE OPEN-LABEL ALN WHILE REMAINING BLINDED TO THEIR INITI
Sponsors
AMGEN INC.,
Eligibility
Sex/Gender
Female
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. AMBULATORY POSTMENOPAUSAL WOMEN , AGE ≥ 60 TO ≤ 90 YEARS AT RANDOMIZATION 2. BMD T-SCORE ≤ -2.50 AT THE TOTAL HIP OR FEMORAL NECK AND AT LEAST ONE MODERATE (Sq2) OR SEVERE (SQ3) VERTEBRAL FRACTURE, AS ASSESSED BY THE CENTRAL IMAGING VENDOR AT THE TIME OF SCREENING, BASED ON DXA SCANS AND LATERAL SPINE X-RAYS. REFER TO SECTIONS 7.13 AND 7.14 FOR DETAILS. 3. AT LEAST ONE HIP IS EVALUABLE BY DXA, AS ASSESSED BY THE PRINCIPALINVESTIGATOR 4. SUBJECT HAS PROVIDED INFORMED CONSENT
Exclusion criteria
Exclusion criteria: USE OF THE FOLLOWING AGENTS AFFECTING BONE METABOLISM 1. STRONTIUM, FLUORIDE (FOR OSTEOPOROSIS), ODANACATIB (MK-0822): AT ANY TIME 2. INTRAVENOUS (IV) BISPHOSPHONATES: DOSE RECEIVED WITHIN 5 YEARS PRIOR TO RANDOMIZATION 3. ORAL BISPHOSPHONATES: . MORE THAN 3 YEARS OF CUMULATIVE USE . ANY DOSE RECEIVED WITHIN 6 MONTHS PRIOR TO RANDOMIZATION . MORE THAN 1 MONTH OF CUMULATIVE USE BETWEEN 6 AND 12 MONTHS PRIOR TO RANDOMIZATION 4. DENOSUMAB: DOSE RECEIVED WITHIN 18 MONTHS PRIOR TO RANDOMIZATION 5. TERIPARATIDE OR ANY PTH ANALOGS: DOSE RECEIVED WITHIN 12 MONTHS PRIOR TO RANDOMIZATION 6. SYSTEMIC ORAL OR TRANSDERMAL ESTROGEN , SERMS, OR CALCITONIN: MORE THAN 1 MONTH OF CUMULATIVE USE WITHIN 6 MONTHS PRIOR TO RANDOMIZATION 7. ANDROGEN DEPRIVATION OR HORMONAL ABLATION THERAPY: MORE THAN 1 MONTH OF CUMULATIVE USE WITHIN 6 MONTHS PRIOR TO RANDOMIZATION 8. TIBOLONE OR CINACALCET: DOSE RECEIVED WITHIN 3 MONTHS PRIOR TO RANDOMIZATION 9. SYSTEMIC GLUCOCORTICOSTEROIDS: ≥ 5 MG PREDNISONE EQUIVALENT PER DAY FOR MORE THAN 10 DAYS WITHIN 3 MONTHS PRIOR TO RANDOMIZATION
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, United Kindgdom, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed