CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 210 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06414616
NCT06414616N/ACompleted

Are We Overly Concerned About Rebound Fractures? Real-World Evidence of Adherence to Denosumab Therapy and Fracture Risk Associated With Drug Withdrawal: A Cross-sectional Study

Trakya University·observational·Posted May 16, 2024·Updated May 16, 2024

In Brief

An observational study for Osteoporosis. Completed, enrolled 210 participants across 1 site.

Detailed Summary

In the light of current literature data, it is not recommended to discontinue Denosumab therapy without initiating another antiresorptive therapy. It is known that there is a rebound increase in bone resorption markers and a rapid decrease in bone mineral density (BMD) when patients using Denosumab remain untreated for 1 year. The coronavirus disease (Covid-19) pandemic has caused an unprecedented disruption in the management of osteoporosis, as in many chronic diseases. This study aims to determine whether the risk of rebound-associated osteoporotic fracture development is increased in patients who discontinued Denosumab therapy due to any reason but especially due to hesitancy to come to hospitals or lack of access to treatment institutions during the pandemic period as well as to evaluate the factors affecting treatment compliance.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 16, 2024
Enrollment StartOct 1, 2022
Primary CompletionMay 1, 2023
Study CompletionMar 1, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.1 years ago