N/A
N=86
Longitudinal Effects of Denosumab on Trabecular Bone Score and Femur Strength Index
Osteoporosis · Bone Fracture
Bottom Line
View on ClinicalTrials.gov: NCT02435147 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Proportion of Change in Mean Trabecular Bone Score — .00238 Proportion of change
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- denosumab (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- HealthEast Care System
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Change in Mean Trabecular Bone Score |
.00238 | — |
| SECONDARY Proportion of Change in Mean Femur Strength Index Score |
.0838 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02435147). 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.