None listed
Conditions
Interventions
THE STUDY IS DESIGNED TO EVALUATE IF TREATMENT WITH
THE STUDY IS DESIGNED TO EVALUATE IF TREATMENT WITH AMG 785 FOR 12 MONTHS, COMPARED WITH PLACEBO, IS EFFECTIVE IN REDUCING THE RISK OF NEW VERTEB
75 YEARS) AND PREVALENT VERTEBRAL FRACTURE (YES, NO). AFTER THE 12-MONTH DOUBLE-BLIND PLACEBO-CONTROLLED STUDY PERIOD, SUBJECTS WILL ENTER THE 12-MONTH OPEN-LABEL DENOSUMAB FOLLOW-UP STUDY PERIOD WHER
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, AS ASSESSED BY THE CENTRAL IMAGING VENDOR AT THE TIME OF SCREENING, BASED ON DXA SCANS. REFER TO SECTION 7.14 FOR DETAILS 3. AT LEAST 2 VERTEBRAE IN THE L1-L4 REGION AND AT LEAST ONE HIP ARE EVALUABLE BY DXA, AS ASSESSED BY THE PRINCIPAL INVESTIGATOR, EG, BASED ON LATERAL SPINE X-RAYS 4. SUBJECT HAS PROVIDED INFORMED CONSENT
Exclusion criteria
Exclusion criteria: 1. BMD T-SCORE 5 -3.50 AT THE TOTAL HIP OR FEMORAL NECK, AS ASSESSED BY THE CENTRAL IMAGING VENDOR AT THE TIME OF SCREENING, BASED ON DXA SCANS. REFER TO SECTION 7.14 FOR DETAILS. 2. HISTORY OF HIP FRACTURE 3. ANY SEVERE (SQ3) OR MORE THAN 2 MODERATE (SQ2) VERTEBRAL FRACTURES, AS ASSESSED BY THE CENTRAL IMAGING BASED ON LATERAL SPINE X-RAYS. REFER TO SECTION 7.16 FOR DETAILS. 4. USE OF THE FOLLOWING AGENTS AFFECTING BONE METABOLISM: . STRONTIUM, FLUORIDE (FOR OSTEOPOROSIS), ODANACATIB (MK-0822): AT ANY TIME . IV BISPHOSPHONATES: DOSE RECEIVED WITHIN 5 YEARS PRIOR TO RANDOMIZATION . 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 . DENOSUMAB: DOSE RECEIVED WITHIN 18 MONTHS PRIOR TO RANDOMIZATION . TERIPARATIDE OR ANY PTH ANALOGS: DOSE RECEIVED WITHIN 12 MONTHS PRIOR TO RANDOMIZATION
Countries
Argentina, Australia, Belgium, Brazil, Canada, Colombia, Czech Republic, Denmark, Dominican Republic, Estonia, Germany, Hungary, India, Japan, Lithuania, Mexico, New Zealand, Poland, Romania, Spain, Switzerland, United Kindgdom, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed