Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Re… (NCT02576652) | Clinical Trial Compass
CompletedPhase 4
Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement
United States6 participantsStarted 2015-12-22
Plain-language summary
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).
Who can participate
Age range50 Years – 100 Years
SexALL
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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 …
What they're measuring
1
Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck
Timeframe: Days 22-58 (at the time of hip replacement surgery)