N/A
N=12
Effect of High Doses of Radiation on Bone Structure and Metabolism
Malignant Bone Tumors
Bottom Line
View on ClinicalTrials.gov: NCT02323295 ↗Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Dec 2021
Primary outcome: Primary: Change in Bone Mineral Density (Tb. BMD) — 4.5; -39.3; -8.7; -54.7 mg/cm^3
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiation (Surgical Arm) (Radiation); Radiation (Non-surgical Arm) (Radiation); Malignant Tumor Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bone Mineral Density (Tb. BMD) |
4.5; -39.3; -8.7; -54.7; 4.1; 5.2 | — |
| SECONDARY Serum N-Telopeptide (NTX) |
21.711; 17.76; 31.447; 24.376; 21.889; 11.217 | — |
| SECONDARY Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) |
3.823813; 3.503794; 4.465143; 4.226845; 3.87936; 4.235948 | — |
| SECONDARY Serum Osteocalcin (OC) |
14.304331; 14.398441; 39.41674; 24.231676; 18.05678; 31.395938 | — |
| SECONDARY Serum Type 1 Procollagen N-terminal (P1NP) |
42.826123; 34.128407; 123.860111; 74.655436; 68.966468; 72.946381 | — |
| SECONDARY Serum Phosphate (P) |
3.9; 3.5; 4.0; 3.6; 3.7; 4.4 | — |
| SECONDARY Serum 25-hydroxycalciferol Vit D (25-OH VitD) |
36.065991; 32.073769; 31.302671; 36.77789; 33.419347; 17.038722 | — |
| SECONDARY Mineral Apposition Rate (MAR) |
0.64; 0.66; 0.55; 0.71; 0.72; 0.44 | — |
| SECONDARY Bone Formation Rate (BFR/BS) |
0.003; 0.003; 0.013; 0.013; 0.014; 0.013 | — |
| SECONDARY Mineralization Lag Time (Mlt) |
40.77; 15.47; 12.56; 68.10; 21.70; 41.88 | — |
| SECONDARY Osteoblast Number (N.Ob/BPm) |
0.26; 0.05; 1.25; 0.05; 1.04; 0.19 | — |
| SECONDARY Osteoblast Surface (Ob. S/BS) |
0.58; 0.10; 2.38; 0.07; 1.63; 0.29 | — |
| SECONDARY Osteoclast Number (N.Oc/BPm) |
0.02; 0.00; 0.03; 0.01; 0.08; 0.02 | — |
| SECONDARY Osteoclast Surface (Oc.S/BS) |
0.12; 0.00; 0.11; 0.02; 0.36; 0.12 | — |
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.
Eligibility Criteria
Inclusion Criteria
- All laboratory tests that are a part of the eligibility criteria must be completed within 14 days prior to the date of registration. Diagnostic tests that are a part of the eligibility criteria must be performed within 30 days of the date of registration. Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Study participants must have histologically confirmed primary malignant bone tumor in the sacrum for which surgery and radiation or radiation alone are planned.
- Age 18 years or older. In children under the age of 8, tetracycline derivatives have been reported to stain tooth enamel yellow color. These considerations lead us to exclude young persons under the age of 18 from the study.
- Participants must have normal organ and marrow function as defined below:
- Total bilirubin within normal institutional limits
- Aspartaataminotransferase (AST) (SGOT)/ Alanine-aminotransferase (ALT) (SGPT) 60 mL/min/1.73 m2 for subjects with creatinine levels about institutional normal limit
- The effects of tetracyclines and radiation used in computer tomography on the developing human fetus are known to be detrimental. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Participants must be able to read and understand English language and have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Participants who have had surgery, chemotherapy, or radiotherapy of the sacrum prior to entering the study
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to tetracyclines.
- Pregnant or nursing
- Uncontrolled inter current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Data sourced from ClinicalTrials.gov (NCT02323295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.