Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-04-18 @ 11:05 AM
Study NCT ID:
NCT02323295
Status:
COMPLETED
Last Update Posted:
2021-12-07
First Post:
2014-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of High Doses of Radiation on Bone Structure and Metabolism
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Pilot Study of the Effect of High Doses of Radiation on Bone Metabolism and Structure in Patients Treated With Adjuvant Radiotherapy and Surgery for Sacral Tumors
Status:
COMPLETED
Status Verified Date:
2021-11
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:
This study is designed to characterize the effects of high energy radiation on bone breakdown, with a specific interest in reducing the rate of sacral fractures. Although radiation is very important in managing tumors, it is related to complications such as bone fractures. In this research study, the investigators are looking to determine changes in blood markers, bone density, and bone structure following radiation and to better understand the reason for these changes.
Detailed Description:
Participants in the Surgical Arm of the study will be treated according to the schedule outlined in protocol for a combined treatment with surgery and adjuvant high dose radiotherapy. Patients in the non surgical arm of the the study will be treated according to the protocol being treated with radiotherapy alone.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| C06CA059267 | NIH | None | https://reporter.nih.gov/quic… | View |