A MULTICENTER, INTERNATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF AMG 785 TREATMENT IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS

AMGEN INC.,0 个研究点目标入组 0 人开始时间: 2013年1月7日最近更新: 2023年9月4日

试验速览

暂无简介。

•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

•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

发起方

AMGEN INC.,