Phase 4
Completed N=6
Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement
Source: ClinicalTrials.gov NCT02576652 ↗Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Apr 2019
Primary outcomePrimary: Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck — 100 percentage of participants
◆ Published Evidence
Established
47citations · ~8 / year
Modeling-Based Bone Formation in the Human Femoral Neck in Subjects Treated With Denosumab.
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).
Linked Publications
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Modeling-Based Bone Formation in the Human Femoral Neck in Subjects Treated With Denosumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck |
100 | — |
| SECONDARY Modeling Based Formation Units in the Femoral Neck |
0.1455; 0.2223; 0.1990 | — |
| SECONDARY Overfilled Remodeling-based Formation Units in the Femoral Neck |
0.0038; 0.0108; 0.0000 | — |
| SECONDARY Remodeling-based Formation Units Including Overfilled Units in the Femoral Neck |
0.0285; 0.0323; 0.0033 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT02576652) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.