Osteoporosis Clinical Trial
Official title:
Longitudinal Effects of Denosumab on Trabecular Bone Score and Femur Strength Index
NCT number | NCT02435147 |
Other study ID # | HE 15 03 003 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | June 2016 |
Verified date | October 2018 |
Source | HealthEast Care System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 86 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | HealthEast Care System | Saint Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
HealthEast Care System | Amgen |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Change in Mean Trabecular Bone Score | Proportion of change in mean trabecular bone score at 36 months following denosumab initiation | Baseline and 36 months | |
Secondary | Proportion of Change in Mean Femur Strength Index Score | Proportion of change in mean Femur Strength Index Score at 36 months following denosumab initiation | Baseline and 36 months |
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