Longitudinal Effects of Denosumab on Trabecular Bone Score and Femur Strength Index
Completed
Conditions studied: Osteoporosis, Bone Fracture
In brief
The purpose of this study is to validate the long-term benefit of denosumab for osteoporosis treatment in a real-world clinical practice setting. We hypothesize that continued therapy (36+months) with denosumab will increase both trabecular bone score (TBS) and femur strength index (FSI) and reduce fracture and other bone health risks among post-menopausal women with osteoporosis.
Key facts
- Study ID
- NCT02435147
- Run by
- HealthEast Care System
- People needed
- 86
- Starts
- 2015-04-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2018-10-29
Who can join
Age: 40 and older, up to 90. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Subjects must meet the following inclusion criteria to be eligible for study entry:
- Post-menopausal female with diagnosed osteoporosis
- Age 40-90 years
- Completed 36 months of denosumab therapy (SQ; 60mg every 6 months) but not yet received the 42 month injection
- Availability of DXA scans at the study-required time points, including the willingness of subjects to undergo a DXA evaluation at 36 months, if required
- Provided written informed consent
You may not qualify if…
- Patients will be excluded from this study for any of the following reasons:
- Received denosumab injections for less than 36 months
- Patients who have missed more than 1 dose of denosumab in a 36 month period
- Contra-indicated for treatment with denosumab
- History of rheumatoid arthritis
- Current diagnosis of hyperparathyroidism; hyperthyroidism; osteomalacia, or other known diseases that can affect bone
- In the opinion of the investigator, have any kind of disorder that may compromise the ability of the subject to provide written informed consent
Where it is running
- HealthEast Care System — Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
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