Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414616
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2022-12-06
Brief Title:
Real-World Evidence of Adherence to Denosumab Therapy and Fracture Risk Associated With Drug Withdrawal A Cross-sectional Study
Sponsor:
Trakya University
Organization:
Trakya University
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
With increased life expectancy and decreased physical activity osteoporosis related fractures are increasing day by day which place a huge health economic burden on societies Since fragility fractures and related disabilities bring about considerable morbidity and even mortality the main goal in osteoporosis treatment is to prevent fractures
The facts that bisphosphonates can plateau after 3-4 years in the treatment response and Teriparatide cannot be used for more than 2 years bring the use of Denosumab to the fore in patients with high fracture risk who need long term treatment Denosumab is also preferred in patients with renal dysfunction since it is excreted by the reticuloendothelial system and not the kidney However there is a dilemma that publications in the literature mostly show that the risk of fracture development returns to a no-treatment status shortly after Denosumab withdrawal
Therefore in this study it is aimed to examine whether there is statistically significant difference in terms of the risk of osteoporotic fracture development and other secondary outcome measures between the patient group who discontinued injections for more than 2 months and the patient group who regularly received their injections
In this study patients who had commenced Denosumab in Trakya University Osteoporosis Polyclinic between 2015-2021 and had received at least 2 doses will be included Demographic and clinical data will be retrospectively examined by the Physical Medicine and Rehabilitation physician at last date of follow-up through electronic medical records and patient files Radiological images of the patients will also be examined whether there is radiological fracture before under or after the treatment The number of fractures and their localizations if any will be recorded The number of Denosumab doses administered will be determined by review of the hospitals electronic prescription records Adherence will be defined as being punctual with an allowable delay of up to 8 weeks with the 6 month scheduled doses In addition pre-treatment values of BMD as evaluated on dual energy x-ray absorptiometry DXA and Fracture Risk Assessment Tool FRAX scores will be recorded
In the light of the data obtained the parameters affecting compliance and the effect of treatment compliance on the risk of osteoporotic fracture development will be presented to the literature
The facts that bisphosphonates can plateau after 3-4 years in the treatment response and Teriparatide cannot be used for more than 2 years bring the use of Denosumab to the fore in patients with high fracture risk who need long term treatment Denosumab is also preferred in patients with renal dysfunction since it is excreted by the reticuloendothelial system and not the kidney However there is a dilemma that publications in the literature mostly show that the risk of fracture development returns to a no-treatment status shortly after Denosumab withdrawal
Therefore in this study it is aimed to examine whether there is statistically significant difference in terms of the risk of osteoporotic fracture development and other secondary outcome measures between the patient group who discontinued injections for more than 2 months and the patient group who regularly received their injections
In this study patients who had commenced Denosumab in Trakya University Osteoporosis Polyclinic between 2015-2021 and had received at least 2 doses will be included Demographic and clinical data will be retrospectively examined by the Physical Medicine and Rehabilitation physician at last date of follow-up through electronic medical records and patient files Radiological images of the patients will also be examined whether there is radiological fracture before under or after the treatment The number of fractures and their localizations if any will be recorded The number of Denosumab doses administered will be determined by review of the hospitals electronic prescription records Adherence will be defined as being punctual with an allowable delay of up to 8 weeks with the 6 month scheduled doses In addition pre-treatment values of BMD as evaluated on dual energy x-ray absorptiometry DXA and Fracture Risk Assessment Tool FRAX scores will be recorded
In the light of the data obtained the parameters affecting compliance and the effect of treatment compliance on the risk of osteoporotic fracture development will be presented to the literature
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None