Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement
Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement
The primary objective of this study is to determine the incidence of modeling-based bone
 formation in the femoral neck in participants who have received denosumab and are undergoing
 total hip replacement (THR).
Inclusion Criteria:

 -  Subject has provided informed consent/assent prior to initiation of any study-specific
 activities/procedures

 -  Ambulatory postmenopausal women and men with osteoporosis

 -  Scheduled to undergo elective THR due to osteoarthritis of the hip

 -  Received at least 2 doses of denosumab 60 mg subcutaneously over 18 months

 -  Last dose of denosumab within 6 months of scheduled THR

 Exclusion Criteria:

 -  Received treatment for osteoporosis other than denosumab in one year prior to THR

 -  Subjects with current diagnosis of any of the following conditions are excluded

 -  Current, uncontrolled hypo- or hyperthyroidism (subjects who have controlled
 hypo- or hyperthyroidism may be eligible, provided that they have been on a
 stable therapy for at least 3 months [per subject report])

 -  Current, hypo- or hyperparathyroidism

 -  Osteomalacia

 -  Paget's disease of bone

 -  Other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis
 imperfecta)

 -  Severe chronic kidney disease (CKD), defined as CKD stage 4 or greater

 -  Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell
 carcinoma)

 -  Self-reported alcohol or drug abuse within the previous 12 months

 -  Currently receiving treatment in another investigational device or drug study, or less
 than 30 days since ending treatment on another investigational device or drug study(s)

 -  Other investigational procedures while participating in this study are excluded

 -  Subject has known sensitivity to any of the products to be administered (eg,
 tetracycline, demeclocycline) during study

 -  Subject likely to not be available to complete all protocol-required study visits or
 procedures, and/or to comply with all required study procedures to the best of the
 subject and investigator's knowledge

 -  History or evidence of any other clinically significant disorder, condition or disease
 (with the exception of those outlined above) that, in the opinion of the investigator
 or Amgen physician, if consulted, would pose a risk to subject safety or interfere
 with the study evaluation, procedures or completion