Bone Histomorphometry of the Proximal Femur in Denosumab-treated Subjects Undergoing Total Hip Replacement
Phase: PHASE4
Conditions: Osteoporosis
Sponsor: Amgen

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Product:  AMG 162 (Denosumab) 
Protocol Number:  20140259 
Date:  03 October 2016 
Page 1 of 4 
CONFIDENTIAL  
 
 
Amendment 2 
Protocol Title:  Bone Histomorphometry of the Proximal Femur in 
Denosumab-treated Subjects Undergoing Total Hip Replacement 
 
Amgen Protocol Number AMG 162 (Denosumab) 20140259 
 
Amendment Date: 
03 October 2016 
Rationale: 
Enrollment has been challenging with the current dosing administration inclusion criteria.  
Decreasing the inclusion criteria that the patient must have received at least 3 doses of 
denosumab 60 mg subcutaneously over 18 months to 2 doses of denosumab 60 mg 
subcutaneously will improve enrollment by doubling the recruitment pool.  The scientific 
advisors for the study have confirmed that the dose administration change will not affect 
the ability to observe the endpoint.  

Product:  AMG 162 (Denosumab) 
Protocol Number:  20140259 
Date:  03 October 2016 
Page 2 of 4 
CONFIDENTIAL  
 
 
Description of Changes: 
Section:  Global 
Change: 
Minor corrections throughout (eg, correcting typographical and formatting errors) 
Section:  Global 
Replace: 
6 April 2015 
With: 
03 October 2016 
Section:  Title Page 
Add: 
Amendment 2:  
03 October 2016 
Section:  Title Page 
Replace: 
One Amgen Center Drive 
Thousand Oaks, CA 91320, USA 
With: 
One Amgen Center Drive 
Thousand Oaks, CA 91320, USA 
PPD
PPD
PPD
PPD

Product:  AMG 162 (Denosumab) 
Protocol Number:  20140259 
Date:  03 October 2016 
Page 3 of 4 
CONFIDENTIAL  
 
 
Section:  Synopsis, Study Design 
Replace: 
This study will enroll approximately 15 subjects who are undergoing elective THR and 
have taken at least 3 doses of denosumab 60 mg within 18 months prior to hip 
replacement surgery. 
With: 
This study will enroll approximately 15 subjects who are undergoing elective THR and 
have taken at least 2 doses of denosumab 60 mg subcutaneously prior to hip 
replacement surgery. 
Section:  Synopsis, Summary of Subject Eligibility Criteria 
Replace: 
• 
received at least 3 doses of denosumab 60 mg subcutaneously over 18 months prior 
to the scheduled THR  
With: 
• 
received at least 2 doses of denosumab 60 mg subcutaneously prior to the 
scheduled THR  
Section:  Study Design and Treatment Schema 
Replace: 
Administration of at least 3 doses of Denosumab 60 mg every 6 months 
(within 18 months) as part of routine care 
With: 
Administration of at least 2 doses of Denosumab 60 mg subcutaneously as part of 
routine care 
Section:  4.1.1 Inclusion Criteria 
Replace: 
104 
Received at least 3 doses of denosumab 60 mg subcutaneously over 18 months 
With: 
104 
Received at least 2 doses of denosumab 60 mg subcutaneously 

Product:  AMG 162 (Denosumab) 
Protocol Number:  20140259 
Date:  03 October 2016 
Page 4 of 4 
CONFIDENTIAL  
 
 
Section:  6.1 Classification of Product(s) and/or Medical Device(s) 
Replace: 
This study will enroll approximately 15 subjects who previously received at least 3 doses 
of denosumab in the 18 months prior and are undergoing THR due to underlying 
osteoarthritis.  
With: 
This study will enroll approximately 15 subjects who previously received at least 2 doses 
of denosumab and are undergoing THR due to underlying osteoarthritis.  
Section:  10.2 Sample Size Considerations 
Replace: 
Approximately 15 subjects who are scheduled to undergo an elective THR procedure 
and have received at least 3 doses of denosumab over the previous 18 months will be 
enrolled in this study. 
With: 
Approximately 15 subjects who are scheduled to undergo an elective THR procedure 
and have received at least 2 doses of denosumab will be enrolled in this study. 

Product:  AMG 162 (Denosumab) 
Protocol Number:  20140259 
Date:  6 April 2015 
 
Page 1 of 24 
CONFIDENTIAL 
 
 
Amendment 1 
Protocol Title:  Bone Histomorphometry of the Proximal Femur in 
Denosumab-treated Subjects Undergoing Total Hip Replacement 
 
Amgen Protocol Number AMG 162/Denosumab 20140259 
 
Amendment Date: 
6 April 2015 
 
Rationale: 
The purpose of this amendment was to update the treatment procedures to improve the 
ability to identify modeling based bone formation during the trial.  Updates have also 
been made to exclusion criteria to address comments received from the Institutional 
Review Board (IRB) overseeing the trial. 
Minor administrative changes and clarifications have also been incorporated.