Bone Histomorphometry of the Proximal Femur in Denosumab-treated Subjects Undergoing Total Hip Replacement
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Osteoporosis
- Sponsor
- Amgen
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck
Time Frame: Days 22-58 (at the time of hip replacement surgery)
Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility. Modeling based formation units in active bone-forming, tetracycline-labeled surfaces were identified by a smooth cement line. The percentage of participants with fluorochrome labeling present in the cancellous or periosteal, or endocortical surfaces of the femoral neck indicative of modeling-based bone formation is reported.
Secondary Outcomes
- Modeling Based Formation Units in the Femoral Neck(Days 22-58 (at the time of hip replacement surgery))
- Overfilled Remodeling-based Formation Units in the Femoral Neck(Days 22-58 (at the time of hip replacement surgery))
- Remodeling-based Formation Units Including Overfilled Units in the Femoral Neck(Days 22-58 (at the time of hip replacement surgery))