A MULTICENTER, INTERNATIONAL, RANDOMIZED, DOUBLE-BIND, ALENDRONATE-CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF AMG 785 IN THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS.

Not Applicable

• Registration Number: PER-085-12
• Lead Sponsor: AMGEN INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-22
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Female
• Target Recruitment: 119

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

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
 

Study & Design

• Study Type: Interventional
• Study Design: Not specified