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 range
50 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)