Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457776
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-08
Brief Title:
Medication Related Osteonecrosis of the Jaws MRONJ in a Cohort of Patients Treated by Antiresorptive Drugs
Sponsor:
Catholic University of the Sacred Heart
Organization:
Catholic University of the Sacred Heart
Study Overview
Official Title:
Medication Related Osteonecrosis of the Jaws MRONJ in a Cohort of Patients Treated by Antiresorptive Drugs a Cohort Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws MRONJ in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors
Detailed Description:
Antiresorptive drugs are widely used for the prevention and treatment of numerous diseases involving the skeletal system In particular they have been shown to be effective in reducing the incidence of skeletal events in oncohematologic patients
Specifically bone represents a highly affected site of metastatic cancer ie bone metastases from solid tumors of various origins--breast prostate renal multiple myeloma In the United States approximately 400000 individuals suffer from bone metastasis The most frequent skeletal complications in patients with bone metastases referred to as SRE - skeletal-related events - in the international literature include pathologic fractures spinal cord compression malignant hypercalcemia and the need to undergo radiation therapy or surgery on the bone lesionThe introduction of anti-bone resorption drugs bisphosphonates and denosumab has reduced the rate of skeletal complications by 30-50 so they are indicated in the management of the oncohematology patient
The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws MRONJ in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors
Specifically bone represents a highly affected site of metastatic cancer ie bone metastases from solid tumors of various origins--breast prostate renal multiple myeloma In the United States approximately 400000 individuals suffer from bone metastasis The most frequent skeletal complications in patients with bone metastases referred to as SRE - skeletal-related events - in the international literature include pathologic fractures spinal cord compression malignant hypercalcemia and the need to undergo radiation therapy or surgery on the bone lesionThe introduction of anti-bone resorption drugs bisphosphonates and denosumab has reduced the rate of skeletal complications by 30-50 so they are indicated in the management of the oncohematology patient
The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws MRONJ in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors
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