NCT06414616Completed
Real-World Evidence of Adherence to Denosumab Therapy and Fracture Risk Associated With Drug Withdrawal: A Cross-sectional Study
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
Source: ClinicalTrials.gov · Last updated 16 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 210 (actual)
- First submitted
- 6 Dec 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 1 May 2023
- Lead sponsor
- Trakya University
- Diseases
- Osteoporosis
- NCT number
- NCT06414616
What you commit to
- Study type: Observational
- Participants enrolled: 210
- From 1 Oct 2022 to the primary completion date, 1 May 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 3\. Patients receiving monthly Denosumab to prevent bone metastasis.
Other illness
- 2\. Patients who develop fractures due to cancer, trauma or Paget's disease.
Other
- 1\. Patients missing any of the above mentioned data
Who the study is looking for
- 1\. Patients who had received at least two consecutive doses of Denosumab ,with a gap of fewer than 8 months, with the diagnosis of osteoporosis.
- 2\. Patients who had at least one radiological image before the initiation of Denosumab therapy in which the lumbar and thoracic spine could be visualised
- 3\. Patients whose BMD and T-score values had been evaluated via DXA scan and FRAX scores had been calculated before the initiation of Denosumab therapy.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Trakya University Medical Faculty Coordinator of this site? Confirm its status | Edirne | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.