Malignant Bone Tumors
Conditions
Keywords
Malignant bone tumors
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.
Interventions
RADIATIONRadiation (Surgical Arm)
For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease)
RADIATIONRadiation (Non-surgical Arm)
Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)
PROCEDUREMalignant Tumor Surgery
Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Sponsors
National Cancer Institute (NCI)
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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) \< 2.5 X institutional upper limit of normal * Creatinine within normal institutional limits or creatinine clearance \> 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bone Mineral Density (Tb. BMD) | Non-surgical arm: baseline, 3 months Surgical arm: baseline, 9 weeks | Trabecular bone mineral density will be measured in mg/cm3 using volumetric Quantitative Computed Tomography (QCT) of L1, L2 and the vertebrae adjacent to the tumor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months | Indicator for Bone Formation, units reported in U/L |
| Serum Osteocalcin (OC) | Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months | Indicator for Bone Formation, units reported in ng/mL |
| Serum Type 1 Procollagen N-terminal (P1NP) | Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months | Indicator for systemic metabolism that can affect bone health, units reported in pg/mL |
| Serum Phosphate (P) | Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months | Indicators for systemic metabolism that can affect bone health, units reported in mg/dL |
| Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months | Indicators for systemic metabolism that can affect bone health, units reported in nmol/L |
| Mineral Apposition Rate (MAR) | Only surgical arm: The months after biopsies are taken during surgery (surgery is during week 4 and 5). These measurements will be done in batches so timeframe isn't clear. | Tetracycline quadruple labeling method will be used and the unit of measure will be um/day |
| Serum N-Telopeptide (NTX) | Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months | Indicator for Bone Formation, units reported in nmol NTX/mmol creatinine |
| Mineralization Lag Time (Mlt) | Only surgical arm: The months after biopsies are taken during surgery (surgery is during week 4 and 5). These measurements will be done in batches so timeframe isn't clear. | Tetracycline quadruple labeling method will be used and the unit of measure will be days |
| Osteoblast Number (N.Ob/BPm) | Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5). | Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1 |
| Osteoblast Surface (Ob. S/BS) | Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5). | Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1 |
| Osteoclast Number (N.Oc/BPm) | Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5). | Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1 |
| Osteoclast Surface (Oc.S/BS) | Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5). | Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1 |
| Bone Formation Rate (BFR/BS) | Only surgical arm: The months after biopsies are taken during surgery (surgery is during week 4 and 5). These measurements will be done in batches so timeframe isn't clear. | Tetracycline quadruple labeling method will be used and the unit of measure will be mm3/mm2/year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non Surgical-Radiation Only Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma
Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) | 2 |
| Malignant Tumor Surgery And Radiation The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later.
Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)
Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor | 10 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Patient did not have surgery as planned. | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Non Surgical-Radiation Only | Malignant Tumor Surgery And Radiation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 9 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 10 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 10 Participants | 11 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 8 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 10 |
| other Total, other adverse events | 0 / 2 | 0 / 10 |
| serious Total, serious adverse events | 0 / 2 | 1 / 10 |
Outcome results
Primary
Change in Bone Mineral Density (Tb. BMD)
Trabecular bone mineral density will be measured in mg/cm3 using volumetric Quantitative Computed Tomography (QCT) of L1, L2 and the vertebrae adjacent to the tumor.
Time frame: Non-surgical arm: baseline, 3 months Surgical arm: baseline, 9 weeks
Population: Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non Surgical-Radiation Only | Change in Bone Mineral Density (Tb. BMD) | Subject 4 (lumbar) | 4.1 mg/cm^3 |
| Non Surgical-Radiation Only | Change in Bone Mineral Density (Tb. BMD) | Subject 4 (sacral) | 5.2 mg/cm^3 |
| Non Surgical-Radiation Only | Change in Bone Mineral Density (Tb. BMD) | Subject 9 (lumbar) | -3.5 mg/cm^3 |
| Non Surgical-Radiation Only | Change in Bone Mineral Density (Tb. BMD) | Subject 9 (sacral) | -55.7 mg/cm^3 |
| Malignant Tumor Surgery And Radiation | Change in Bone Mineral Density (Tb. BMD) | Subject 6 (lumbar) | -2.6 mg/cm^3 |
| Malignant Tumor Surgery And Radiation | Change in Bone Mineral Density (Tb. BMD) | Subject 6 (sacral) | -32.7 mg/cm^3 |
| Malignant Tumor Surgery And Radiation | Change in Bone Mineral Density (Tb. BMD) | Subject 7 (lumbar) | 3.6 mg/cm^3 |
| Malignant Tumor Surgery And Radiation | Change in Bone Mineral Density (Tb. BMD) | Subject 7 (sacral) | -14.8 mg/cm^3 |
| Malignant Tumor Surgery And Radiation | Change in Bone Mineral Density (Tb. BMD) | Subject 8 (lumbar) | -2.2 mg/cm^3 |
| Malignant Tumor Surgery And Radiation | Change in Bone Mineral Density (Tb. BMD) | Subject 8 (sacral) | -57.7 mg/cm^3 |
| Malignant Tumor Surgery And Radiation | Change in Bone Mineral Density (Tb. BMD) | Subject 10 (lumbar) | -0.2 mg/cm^3 |
| Malignant Tumor Surgery And Radiation | Change in Bone Mineral Density (Tb. BMD) | Subject 10 (sacral) | -70.3 mg/cm^3 |
| Malignant Tumor Surgery And Radiation | Change in Bone Mineral Density (Tb. BMD) | Subject 12 (lumbar) | 3.3 mg/cm^3 |
| Malignant Tumor Surgery And Radiation | Change in Bone Mineral Density (Tb. BMD) | Subject 2 (lumbar) | 4.5 mg/cm^3 |
| Malignant Tumor Surgery And Radiation | Change in Bone Mineral Density (Tb. BMD) | Subject 12 (sacral) | -37.9 mg/cm^3 |
| Malignant Tumor Surgery And Radiation | Change in Bone Mineral Density (Tb. BMD) | Subject 2 (sacral) | -39.3 mg/cm^3 |
| Malignant Tumor Surgery And Radiation | Change in Bone Mineral Density (Tb. BMD) | Subject 3 (lumbar) | -8.7 mg/cm^3 |
| Malignant Tumor Surgery And Radiation | Change in Bone Mineral Density (Tb. BMD) | Subject 3 (sacral) | -54.7 mg/cm^3 |
Secondary
Bone Formation Rate (BFR/BS)
Tetracycline quadruple labeling method will be used and the unit of measure will be mm3/mm2/year
Time frame: Only surgical arm: The months after biopsies are taken during surgery (surgery is during week 4 and 5). These measurements will be done in batches so timeframe isn't clear.
Population: B = before radiation, A = after radiation. For missing values, certain tests were not performed at certain timepoints for some subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 2 (Iliac Crest, Cancellous, B) | 0.003 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 2 (iliac Crest, Cancellous, A) | 0.003 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 2 (Iliac Crest, Endocortical, B) | 0.013 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 2 (Iliac Crest, Endocortical, A) | 0.013 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 2 (Iliac Crest, Intracortical, B) | 0.014 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 2 (Iliac Crest, Intracortical, A) | 0.013 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 2 (Iliac Crest, Periosteal, B) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 2 (Iliac Crest, Periosteal, A) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 2 (Sacrum, Cancellous, B) | 0.007 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 2 (Sacrum, Cancellous, A) | 0.001 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 2 (Sacrum, Endocortical, B) | 0.052 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 12 (Sacrum, Intracortical, B) | 0.063 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Iliac Crest, Cancellous, A) | 0.006 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Iliac Crest, Endocortical, B) | 0.019 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Iliac Crest, Endocortical, A) | 0.024 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Iliac Crest, Intracortical, B) | 0.029 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 7 (Iliac Crest, Cancellous, B) | 0.012 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 7 (Iliac Crest, Cancellous, A) | 0.031 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 7 (Iliac Crest, Endocortical, A) | 0.004 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 7 (Iliac Crest, Intracortical, B) | 0.057 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 7 (Iliac Crest, Periosteal, B) | 0.007 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 7 (Iliac Crest, Periosteal, A) | 0.036 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 7 (Sacrum, Cancellous, B) | 0.011 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 7 (Sacrum, Cancellous, A) | 0.007 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 7 (Sacrum, Endocortical, B) | 0.004 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 7 (Sacrum, Endocortical, A) | 0.007 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 7 (Sacrum, Intracortical, B) | 0.004 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 7 (Sacrum, Intracortical, A) | 0.002 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 7 (Sacrum, Periosteal, B) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 7 (Sacrum, Periosteal, A) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 8 (Iliac Crest, Cancellous, B) | 0.004 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 8 (Iliac Crest, Cancellous, A) | 0.001 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 8 (Iliac Crest, Endocortical, B) | 0.016 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 12 (Iliac Crest, Intracortical, B) | 0.017 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 12 (Sacrum, Cancellous, B) | 0.005 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 12 (Sacrum, Endocortical, B) | 0.017 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 12 (Sacrum, Periosteal, B) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Sacrum, Intracortical, A) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Iliac Crest, Intracortical, A) | 0.041 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Iliac Crest, Periosteal, B) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Iliac Crest, Periosteal, A) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Sacrum, Cancellous, B) | 0.003 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Sacrum, Cancellous, A) | 0.001 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Sacrum, Endocortical, B) | 0.010 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Sacrum, Endocortical, A) | 0.001 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Sacrum, Intracortical, B) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Sacrum, Periosteal, B) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Sacrum, Periosteal, A) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 8 (Iliac Crest, Endocortical, A) | 0.007 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 8 (Iliac Crest, Intracortical, B) | 0.039 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 8 (Iliac Crest, Intracortical, A) | 0.035 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 8 (Iliac Crest, Periosteal, B) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 8 (Iliac Crest, Periosteal, A) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 8 (Sacrum, Cancellous, B) | 0.005 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 10 (Iliac Crest, Cancellous, B) | 0.022 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 10 (Iliac Crest, Cancellous, A) | 0.016 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 10 (Iliac Crest, Endocortical, B) | 0.022 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 10 (Iliac Crest, Endocortical, A) | 0.030 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 10 (Iliac Crest, Intracortical, B) | 0.023 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 10 (Iliac Crest, Intracortical, A) | 0.032 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 10 (Iliac Crest, Periosteal, B) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 10 (Iliac Crest, Periosteal, A) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 10 (Sacrum, Cancellous, B) | 0.003 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 10 (Sacrum, Cancellous, A) | 0.001 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 10 (Sacrum, Endocortical, B) | 0.002 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 10 (Sacrum, Intracortical, B) | 0.013 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 10 (Sacrum, Periosteal, B) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 10 (Sacrum, Periosteal, A) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 12 (Iliac Crest, Cancellous, B) | 0.018 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 12 (Iliac Crest, Endocortical, B) | 0.028 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 2 (Sacrum, Intracortical, B) | 0.053 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 2 (Sacrum, Intracortical, A) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 2 (Sacrum, Periosteal, B) | 0.012 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 2 (Sacrum, Periosteal, A) | 0.004 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 3 (Iliac Crest, Cancellous, B) | 0.016 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 3 (Iliac Crest, Cancellous, A) | 0.012 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 3 (Iliac Crest, Endocortical, B) | 0.021 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 3 (Iliac Crest, Endocortical, A) | 0.009 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 3 (Iliac Crest, Intracortical, B) | 0.047 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 3 (Iliac Crest, Intracortical, A) | 0.032 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 3 (Iliac Crest, Periosteal, B) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 3 (Iliac Crest, Periosteal, A) | 0.000 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 3 (Sacrum, Cancellous, B) | 0.009 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 3 (Sacrum, Cancellous, A) | 0.001 mm3/mm2/year |
| Malignant Tumor Surgery And Radiation | Bone Formation Rate (BFR/BS) | Subject 6 (Iliac Crest, Cancellous, B) | 0.005 mm3/mm2/year |
Secondary
Mineral Apposition Rate (MAR)
Tetracycline quadruple labeling method will be used and the unit of measure will be um/day
Time frame: Only surgical arm: The months after biopsies are taken during surgery (surgery is during week 4 and 5). These measurements will be done in batches so timeframe isn't clear.
Population: B = before radiation, A = after radiation. For missing values, certain tests were not performed at certain timepoints for some subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 3 (Iliac Crest, Intracortical, B) | 0.64 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 3 (Iliac Crest, Intracortical, A) | 0.59 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 3 (Sacrum, Cancellous, B) | 0.62 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 3 (Sacrum, Cancellous, A) | 0.34 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 6 (Iliac Crest, Intracortical, B) | 1.12 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 6 (Iliac Crest, Intracortical, A) | 0.50 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 6 (Sacrum, Cancellous, B) | 0.51 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 6 (Sacrum, Cancellous, A) | 0.37 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 6 (Sacrum, Endocortical, B) | 0.55 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 6 (Sacrum, Endocortical, A) | 0.18 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 7 (Iliac Crest, Cancellous, B) | 0.65 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 12 (Iliac Crest, Cancellous, B) | 0.53 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 12 (Iliac Crest, Endocortical, B) | 0.48 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 12 (Iliac Crest, Intracortical, B) | 0.96 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 12 (Sacrum, Cancellous, B) | 0.47 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 12 (Sacrum, Endocortical, B) | 0.50 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 12 (Sacrum, Intracortical, B) | 1.31 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 2 (Iliac Crest, Cancellous, B) | 0.64 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 2 (iliac Crest, Cancellous, A) | 0.66 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 2 (Iliac Crest, Endocortical, B) | 0.55 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 2 (Iliac Crest, Endocortical, A) | 0.71 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 2 (Iliac Crest, Intracortical, B) | 0.72 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 2 (Iliac Crest, Intracortical, A) | 0.44 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 2 (Sacrum, Cancellous, B) | 0.58 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 2 (Sacrum, Cancellous, A) | 0.45 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 2 (Sacrum, Endocortical, B) | 0.70 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 2 (Sacrum, Intracortical, B) | 0.47 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 2 (Sacrum, Periosteal, B) | 1.50 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 2 (Sacrum, Periosteal, A) | 0.98 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 3 (Iliac Crest, Cancellous, B) | 0.64 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 3 (Iliac Crest, Cancellous, A) | 0.54 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 3 (Iliac Crest, Endocortical, B) | 0.53 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 3 (Iliac Crest, Endocortical, A) | 0.46 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 6 (Iliac Crest, Cancellous, B) | 0.51 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 6 (Iliac Crest, Cancellous, A) | 0.40 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 6 (Iliac Crest, Endocortical, B) | 0.51 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 6 (Iliac Crest, Endocortical, A) | 0.43 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 7 (Iliac Crest, Cancellous, A) | 0.72 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 7 (Iliac Crest, Endocortical, A) | 0.48 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 7 (Iliac Crest, Intracortical, B) | 1.20 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 7 (Iliac Crest, Periosteal, B) | 0.33 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 7 (Iliac Crest, Periosteal, A) | 0.47 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 7 (Sacrum, Cancellous, B) | 0.69 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 7 (Sacrum, Cancellous, A) | 0.59 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 7 (Sacrum, Endocortical, B) | 0.41 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 7 (Sacrum, Endocortical, A) | 0.76 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 7 (Sacrum, Intracortical, B) | 0.92 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 7 (Sacrum, Intracortical, A) | 0.68 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 8 (Iliac Crest, Cancellous, B) | 0.62 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 8 (Iliac Crest, Cancellous, A) | 0.43 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 8 (Iliac Crest, Endocortical, B) | 0.51 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 8 (Iliac Crest, Endocortical, A) | 0.33 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 8 (Iliac Crest, Intracortical, B) | 1.83 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 8 (Iliac Crest, Intracortical, A) | 0.73 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 8 (Sacrum, Cancellous, B) | 0.56 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 10 (Iliac Crest, Cancellous, B) | 0.60 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 10 (Iliac Crest, Cancellous, A) | 0.40 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 10 (Iliac Crest, Endocortical, B) | 0.42 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 10 (Iliac Crest, Endocortical, A) | 0.41 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 10 (Iliac Crest, Intracortical, B) | 0.49 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 10 (Iliac Crest, Intracortical, A) | 0.53 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 10 (Sacrum, Cancellous, B) | 0.50 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 10 (Sacrum, Cancellous, A) | 0.49 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 10 (Sacrum, Endocortical, B) | 0.44 um/day |
| Malignant Tumor Surgery And Radiation | Mineral Apposition Rate (MAR) | Subject 10 (Sacrum, Intracortical, B) | 0.60 um/day |
Secondary
Mineralization Lag Time (Mlt)
Tetracycline quadruple labeling method will be used and the unit of measure will be days
Time frame: Only surgical arm: The months after biopsies are taken during surgery (surgery is during week 4 and 5). These measurements will be done in batches so timeframe isn't clear.
Population: A = after radiation. No periosteal data for any subject. For other missing values, certain tests were not performed at certain timepoints for some subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 2 (iliac Crest, Cancellous, A) | 40.77 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 10 (Iliac Crest, Endocortical, A) | 34.23 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 10 (Iliac Crest, Intracortical, A) | 26.65 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 10 (Sacrum, Cancellous, A) | 142.08 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 2 (Iliac Crest, Endocortical, A) | 15.47 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 2 (Iliac Crest, Intracortical, A) | 12.56 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 2 (Sacrum, Cancellous, A) | 68.10 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 3 (Iliac Crest, Cancellous, A) | 21.70 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 3 (Iliac Crest, Endocortical, A) | 41.88 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 3 (Iliac Crest, Intracortical, A) | 20.33 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 3 (Sacrum, Cancellous, A) | 7.45 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 6 (Iliac Crest, Cancellous, A) | 24.98 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 6 (Iliac Crest, Endocortical, A) | 13.31 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 6 (Iliac Crest, Intracortical, A) | 16.36 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 6 (Sacrum, Cancellous, A) | 110.51 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 6 (Sacrum, Endocortical, A) | 40.28 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 7 (Iliac Crest, Cancellous, A) | 16.28 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 7 (Iliac Crest, Endocortical, A) | 15.49 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 7 (Sacrum, Cancellous, A) | 34.10 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 7 (Sacrum, Endocortical, A) | 37.18 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 7 (Sacrum, Intracortical, A) | 87.15 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 8 (Iliac Crest, Cancellous, A) | 3.11 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 8 (Iliac Crest, Endocortical, A) | 10.72 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 8 (Iliac Crest, Intracortical, A) | 8.15 days |
| Malignant Tumor Surgery And Radiation | Mineralization Lag Time (Mlt) | Subject 10 (Iliac Crest, Cancellous, A) | 63.18 days |
Secondary
Osteoblast Number (N.Ob/BPm)
Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1
Time frame: Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).
Population: No biopsy data for subjects 10 and 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Malignant Tumor Surgery And Radiation | Osteoblast Number (N.Ob/BPm) | Subject 2 (week 5) | 0.26 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Number (N.Ob/BPm) | Subject 3 (week 6) | 0.05 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Number (N.Ob/BPm) | Subject 6 (week 5) | 1.04 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Number (N.Ob/BPm) | Subject 6 (week 6) | 0.19 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Number (N.Ob/BPm) | Subject 7 (week 5) | 6.23 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Number (N.Ob/BPm) | Subject 7 (week 6) | 1.89 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Number (N.Ob/BPm) | Subject 8 (week 5) | 0.05 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Number (N.Ob/BPm) | Subject 8 (week 6) | 0.16 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Number (N.Ob/BPm) | Subject 2 (week 6) | 0.05 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Number (N.Ob/BPm) | Subject 3 (week 5) | 1.25 1/mm |
Secondary
Osteoblast Surface (Ob. S/BS)
Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1
Time frame: Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).
Population: No biopsy data for subjects 10 and 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Malignant Tumor Surgery And Radiation | Osteoblast Surface (Ob. S/BS) | Subject 2 (week 5) | 0.58 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Surface (Ob. S/BS) | Subject 2 (week 6) | 0.10 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Surface (Ob. S/BS) | Subject 3 (week 5) | 2.38 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Surface (Ob. S/BS) | Subject 3 (week 6) | 0.07 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Surface (Ob. S/BS) | Subject 6 (week 5) | 1.63 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Surface (Ob. S/BS) | Subject 6 (week 6) | 0.29 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Surface (Ob. S/BS) | Subject 7 (week 5) | 9.07 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Surface (Ob. S/BS) | Subject 7 (week 6) | 2.71 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Surface (Ob. S/BS) | Subject 8 (week 5) | 0.05 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoblast Surface (Ob. S/BS) | Subject 8 (week 6) | 0.23 1/mm |
Secondary
Osteoclast Number (N.Oc/BPm)
Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1
Time frame: Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).
Population: No biopsy data for subjects 10 and 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Malignant Tumor Surgery And Radiation | Osteoclast Number (N.Oc/BPm) | Subject 8 (week 6) | 0.07 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Number (N.Oc/BPm) | Subject 8 (week 5) | 0 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Number (N.Oc/BPm) | Subject 2 (week 5) | 0.02 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Number (N.Oc/BPm) | Subject 2 (week 6) | 0.00 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Number (N.Oc/BPm) | Subject 3 (week 5) | 0.03 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Number (N.Oc/BPm) | Subject 3 (week 6) | 0.01 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Number (N.Oc/BPm) | Subject 6 (week 5) | 0.08 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Number (N.Oc/BPm) | Subject 6 (week 6) | 0.02 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Number (N.Oc/BPm) | Subject 7 (week 5) | 0.10 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Number (N.Oc/BPm) | Subject 7 (week 6) | 0.31 1/mm |
Secondary
Osteoclast Surface (Oc.S/BS)
Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1
Time frame: Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).
Population: No biopsy data for subjects 10 and 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Malignant Tumor Surgery And Radiation | Osteoclast Surface (Oc.S/BS) | Subject 2 (week 6) | 0.00 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Surface (Oc.S/BS) | Subject 2 (week 5) | 0.12 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Surface (Oc.S/BS) | Subject 3 (week 5) | 0.11 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Surface (Oc.S/BS) | Subject 3 (week 6) | 0.02 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Surface (Oc.S/BS) | Subject 6 (week 5) | 0.36 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Surface (Oc.S/BS) | Subject 6 (week 6) | 0.12 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Surface (Oc.S/BS) | Subject 7 (week 5) | 0.44 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Surface (Oc.S/BS) | Subject 7 (week 6) | 1.27 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Surface (Oc.S/BS) | Subject 8 (week 5) | 0.00 1/mm |
| Malignant Tumor Surgery And Radiation | Osteoclast Surface (Oc.S/BS) | Subject 8 (week 6) | 0.29 1/mm |
Secondary
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Indicators for systemic metabolism that can affect bone health, units reported in nmol/L
Time frame: Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months
Population: Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column.~For other missing values, certain tests were not performed at certain timepoints for some subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non Surgical-Radiation Only | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 4 (7 weeks) | 38.703589 nmol/L |
| Non Surgical-Radiation Only | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 4 (about 8 months) | 62.317379 nmol/L |
| Non Surgical-Radiation Only | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 9 (7 weeks) | 40.21479 nmol/L |
| Non Surgical-Radiation Only | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 9 (about 5 months) | 41.193903 nmol/L |
| Non Surgical-Radiation Only | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 9 (about 8 months) | 47.316427 nmol/L |
| Non Surgical-Radiation Only | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 9 (baseline) | 39.515148 nmol/L |
| Non Surgical-Radiation Only | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 9 (3.5 weeks) | 39.281166 nmol/L |
| Non Surgical-Radiation Only | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 4 (baseline) | 60.483526 nmol/L |
| Non Surgical-Radiation Only | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 4 (3.5 weeks) | 50.942045 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 2 (about 7 months) | 36.77789 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 2 (about 10 months) | 33.419347 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 3 (baseline) | 17.038722 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 3 (5.5 weeks) | 12.739664 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 6 (baseline) | 36.051246 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 6 (5.5 weeks) | 35.309918 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 6 (18.5 weeks) | 36.748899 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 6 (about 7 months) | 32.918895 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 6 (about 10 months) | 36.262804 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 7 (baseline) | 17.740625 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 7 (5.5 weeks) | 17.258697 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 7 (18.5 weeks) | 27.862934 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 10 (baseline) | 30.093394 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 10 (5.5 weeks) | 30.491835 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 10 (18.5 weeks) | 27.330808 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 10 (about 7 months) | 28.958284 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 12 (baseline) | 18.366566 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 12 (5.5 weeks) | 25.333837 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 12 (18.5 weeks) | 31.425202 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 7 (about 10 months) | 20.845497 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 12 (about 7 months) | 32.557435 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 8 (baseline) | 23.596514 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 8 (5.5 weeks) | 22.190329 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 8 (18.5 weeks) | 27.355142 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 8 (about 7 months) | 29.649107 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 8 (about 10 months) | 25.399281 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 2 (baseline) | 36.065991 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 2 (5.5 weeks) | 32.073769 nmol/L |
| Malignant Tumor Surgery And Radiation | Serum 25-hydroxycalciferol Vit D (25-OH VitD) | Subject 2 (18.5 Weeks) | 31.302671 nmol/L |
Secondary
Serum N-Telopeptide (NTX)
Indicator for Bone Formation, units reported in nmol NTX/mmol creatinine
Time frame: Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months
Population: Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column.~For other missing values, certain tests were not performed at certain timepoints for some subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non Surgical-Radiation Only | Serum N-Telopeptide (NTX) | Subject 9 (about 8 months) | 11.155 nM/L |
| Non Surgical-Radiation Only | Serum N-Telopeptide (NTX) | Subject 4 (7 weeks) | 6.205 nM/L |
| Non Surgical-Radiation Only | Serum N-Telopeptide (NTX) | Subject 4 (about 8 months) | 7.218 nM/L |
| Non Surgical-Radiation Only | Serum N-Telopeptide (NTX) | Subject 4 (baseline) | 4.614 nM/L |
| Non Surgical-Radiation Only | Serum N-Telopeptide (NTX) | Subject 4 (3.5 weeks) | 7.366 nM/L |
| Non Surgical-Radiation Only | Serum N-Telopeptide (NTX) | Subject 9 (baseline) | 8.028 nM/L |
| Non Surgical-Radiation Only | Serum N-Telopeptide (NTX) | Subject 9 (3.5 weeks) | 12.435 nM/L |
| Non Surgical-Radiation Only | Serum N-Telopeptide (NTX) | Subject 9 (7 weeks) | 7.642 nM/L |
| Non Surgical-Radiation Only | Serum N-Telopeptide (NTX) | Subject 9 (about 5 months) | 11.163 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 6 (18.5 weeks) | 20.922 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 6 (about 7 months) | 16.707 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 6 (about 10 months) | 14.096 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 7 (baseline) | 15.949 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 7 (5.5 weeks) | 8.942 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 7 (18.5 weeks) | 25.817 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 7 (about 10 months) | 18.513 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 8 (baseline) | 11.97 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 8 (5.5 weeks) | 19.065 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 8 (18.5 weeks) | 22.917 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 8 (about 7 months) | 26.767 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 8 (about 10 months) | 18.116 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 10 (baseline) | 11.082 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 10 (5.5 weeks) | 7.763 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 10 (18.5 weeks) | 10.123 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 10 (about 7 months) | 9.89 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 12 (baseline) | 12.656 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 12 (5.5 weeks) | 10.511 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 12 (18.5 weeks) | 14.693 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 2 (about 7 months) | 24.376 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 12 (about 7 months) | 15.177 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 2 (baseline) | 21.711 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 2 (5.5 weeks) | 17.76 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 2 (18.5 Weeks) | 31.447 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 2 (about 10 months) | 21.889 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 3 (baseline) | 11.217 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 3 (5.5 weeks) | 14.294 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 6 (baseline) | 15.932 nM/L |
| Malignant Tumor Surgery And Radiation | Serum N-Telopeptide (NTX) | Subject 6 (5.5 weeks) | 19.973 nM/L |
Secondary
Serum Osteocalcin (OC)
Indicator for Bone Formation, units reported in ng/mL
Time frame: Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months
Population: Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column.~For other missing values, certain tests were not performed at certain timepoints for some subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non Surgical-Radiation Only | Serum Osteocalcin (OC) | Subject 9 (about 8 months) | 10.028165 ng/mL |
| Non Surgical-Radiation Only | Serum Osteocalcin (OC) | Subject 4 (3.5 weeks) | 8.504592 ng/mL |
| Non Surgical-Radiation Only | Serum Osteocalcin (OC) | Subject 4 (7 weeks) | 10.025644 ng/mL |
| Non Surgical-Radiation Only | Serum Osteocalcin (OC) | Subject 4 (about 8 months) | 10.54423 ng/mL |
| Non Surgical-Radiation Only | Serum Osteocalcin (OC) | Subject 4 (baseline) | 7.70232 ng/mL |
| Non Surgical-Radiation Only | Serum Osteocalcin (OC) | Subject 9 (baseline) | 12.220099 ng/mL |
| Non Surgical-Radiation Only | Serum Osteocalcin (OC) | Subject 9 (about 5 months) | 11.167479 ng/mL |
| Non Surgical-Radiation Only | Serum Osteocalcin (OC) | Subject 9 (3.5 weeks) | 12.368649 ng/mL |
| Non Surgical-Radiation Only | Serum Osteocalcin (OC) | Subject 9 (7 weeks) | 10.955072 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 6 (18.5 weeks) | 13.061037 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 6 (about 7 months) | 25.763047 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 6 (about 10 months) | 18.419998 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 7 (baseline) | 4.378182 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 7 (5.5 weeks) | 10.369156 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 7 (18.5 weeks) | 40.882969 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 7 (about 10 months) | 28.262384 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 8 (baseline) | 13.966 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 8 (5.5 weeks) | 16.786965 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 8 (18.5 weeks) | 32.353007 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 8 (about 7 months) | 29.73705 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 8 (about 10 months) | 26.099775 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 10 (baseline) | 12.321595 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 10 (5.5 weeks) | 14.881427 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 10 (18.5 weeks) | 19.861684 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 10 (about 7 months) | 16.437832 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 12 (baseline) | 17.549564 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 12 (5.5 weeks) | 17.154958 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 12 (18.5 weeks) | 11.480525 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 2 (18.5 Weeks) | 39.41674 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 12 (about 7 months) | 16.409198 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 2 (about 7 months) | 24.231676 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 2 (about 10 months) | 18.05678 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 6 (5.5 weeks) | 12.869497 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 2 (baseline) | 14.304331 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 2 (5.5 weeks) | 14.398441 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 3 (baseline) | 31.395938 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 3 (5.5 weeks) | 16.128416 ng/mL |
| Malignant Tumor Surgery And Radiation | Serum Osteocalcin (OC) | Subject 6 (baseline) | 10.954567 ng/mL |
Secondary
Serum Phosphate (P)
Indicators for systemic metabolism that can affect bone health, units reported in mg/dL
Time frame: Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months
Population: Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column.~For other missing values, certain tests were not performed at certain timepoints for some subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non Surgical-Radiation Only | Serum Phosphate (P) | Subject 9 (about 5 months) | 4.2 mg/dL |
| Non Surgical-Radiation Only | Serum Phosphate (P) | Subject 9 (about 8 months) | 3.4 mg/dL |
| Non Surgical-Radiation Only | Serum Phosphate (P) | Subject 4 (7 weeks) | 3.0 mg/dL |
| Non Surgical-Radiation Only | Serum Phosphate (P) | Subject 4 (about 8 months) | 3.2 mg/dL |
| Non Surgical-Radiation Only | Serum Phosphate (P) | Subject 4 (baseline) | 2.8 mg/dL |
| Non Surgical-Radiation Only | Serum Phosphate (P) | Subject 4 (3.5 weeks) | 3.0 mg/dL |
| Non Surgical-Radiation Only | Serum Phosphate (P) | Subject 9 (baseline) | 4.3 mg/dL |
| Non Surgical-Radiation Only | Serum Phosphate (P) | Subject 9 (3.5 weeks) | 4.0 mg/dL |
| Non Surgical-Radiation Only | Serum Phosphate (P) | Subject 9 (7 weeks) | 4.7 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 2 (about 10 months) | 3.7 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 3 (baseline) | 4.4 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 3 (5.5 weeks) | 4.3 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 6 (baseline) | 3.4 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 6 (5.5 weeks) | 3.3 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 6 (18.5 weeks) | 4.4 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 6 (about 7 months) | 4.1 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 6 (about 10 months) | 3.6 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 7 (baseline) | 3.3 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 7 (5.5 weeks) | 4.0 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 7 (18.5 weeks) | 4.9 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 7 (about 10 months) | 4.0 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 8 (baseline) | 3.3 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 10 (baseline) | 2.4 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 10 (5.5 weeks) | 4.0 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 10 (18.5 weeks) | 3.5 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 10 (about 7 months) | 2.2 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 12 (baseline) | 4.2 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 12 (18.5 weeks) | 3.4 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 2 (baseline) | 3.9 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 12 (about 7 months) | 3.4 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 2 (5.5 weeks) | 3.5 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 8 (5.5 weeks) | 3.3 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 8 (18.5 weeks) | 3.5 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 8 (about 7 months) | 3.7 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 8 (about 10 months) | 3.3 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 12 (5.5 weeks) | 3.7 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 2 (18.5 Weeks) | 4.0 mg/dL |
| Malignant Tumor Surgery And Radiation | Serum Phosphate (P) | Subject 2 (about 7 months) | 3.6 mg/dL |
Secondary
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Indicator for Bone Formation, units reported in U/L
Time frame: Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months
Population: Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column.~For other missing values, certain tests were not performed at certain timepoints for some subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non Surgical-Radiation Only | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 9 (about 8 months) | 2.194518 U/L |
| Non Surgical-Radiation Only | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 4 (7 weeks) | 3.22168 U/L |
| Non Surgical-Radiation Only | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 4 (about 8 months) | 2.830882 U/L |
| Non Surgical-Radiation Only | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 4 (baseline) | 2.951546 U/L |
| Non Surgical-Radiation Only | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 4 (3.5 weeks) | 3.597596 U/L |
| Non Surgical-Radiation Only | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 9 (baseline) | 2.461792 U/L |
| Non Surgical-Radiation Only | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 9 (3.5 weeks) | 2.601314 U/L |
| Non Surgical-Radiation Only | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 9 (7 weeks) | 3.056594 U/L |
| Non Surgical-Radiation Only | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 9 (about 5 months) | 3.203289 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 6 (18.5 weeks) | 6.675976 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 6 (about 7 months) | 4.910525 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 6 (about 10 months) | 3.99912 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 7 (baseline) | 5.051881 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 7 (5.5 weeks) | 4.211249 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 7 (18.5 weeks) | 5.499551 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 7 (about 10 months) | 3.725495 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 8 (baseline) | 3.890646 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 8 (5.5 weeks) | 4.353515 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 8 (18.5 weeks) | 5.2026 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 8 (about 7 months) | 5.025804 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 8 (about 10 months) | 3.984603 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 10 (baseline) | 3.122802 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 10 (5.5 weeks) | 2.776157 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 10 (18.5 weeks) | 3.329006 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 10 (about 7 months) | 2.496301 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 12 (baseline) | 3.702653 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 12 (5.5 weeks) | 3.986177 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 12 (18.5 weeks) | 3.969791 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 2 (baseline) | 3.823813 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 12 (about 7 months) | 3.615732 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 2 (5.5 weeks) | 3.503794 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 2 (18.5 Weeks) | 4.465143 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 2 (about 7 months) | 4.226845 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 2 (about 10 months) | 3.87936 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 3 (baseline) | 4.235948 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 3 (5.5 weeks) | 5.111555 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 6 (baseline) | 5.482747 U/L |
| Malignant Tumor Surgery And Radiation | Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) | Subject 6 (5.5 weeks) | 4.700929 U/L |
Secondary
Serum Type 1 Procollagen N-terminal (P1NP)
Indicator for systemic metabolism that can affect bone health, units reported in pg/mL
Time frame: Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months
Population: Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column.~For other missing values, certain tests were not performed at certain timepoints for some subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non Surgical-Radiation Only | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 9 (7 weeks) | 40.145122 pg/mL |
| Non Surgical-Radiation Only | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 9 (about 5 months) | 42.945924 pg/mL |
| Non Surgical-Radiation Only | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 4 (3.5 weeks) | 28.095207 pg/mL |
| Non Surgical-Radiation Only | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 4 (7 weeks) | 32.953174 pg/mL |
| Non Surgical-Radiation Only | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 4 (about 8 months) | 43.37268 pg/mL |
| Non Surgical-Radiation Only | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 4 (baseline) | 21.375865 pg/mL |
| Non Surgical-Radiation Only | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 9 (about 8 months) | 33.200638 pg/mL |
| Non Surgical-Radiation Only | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 9 (baseline) | 51.29302 pg/mL |
| Non Surgical-Radiation Only | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 9 (3.5 weeks) | 38.642487 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 7 (about 10 months) | 98.31769 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 8 (baseline) | 39.183829 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 8 (5.5 weeks) | 56.609907 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 8 (18.5 weeks) | 219.86073 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 8 (about 7 months) | 129.372101 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 8 (about 10 months) | 99.637646 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 12 (about 7 months) | 64.002627 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 2 (baseline) | 42.826123 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 2 (5.5 weeks) | 34.128407 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 2 (18.5 Weeks) | 123.860111 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 2 (about 7 months) | 74.655436 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 2 (about 10 months) | 68.966468 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 3 (baseline) | 72.946381 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 10 (baseline) | 53.568154 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 10 (5.5 weeks) | 59.57128 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 10 (18.5 weeks) | 114.083432 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 10 (about 7 months) | 59.498204 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 12 (baseline) | 47.539351 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 12 (5.5 weeks) | 50.82762 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 3 (5.5 weeks) | 44.08789 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 12 (18.5 weeks) | 72.878306 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 6 (baseline) | 129.054174 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 6 (5.5 weeks) | 83.031563 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 6 (18.5 weeks) | 152.713648 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 6 (about 7 months) | 186.103683 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 6 (about 10 months) | 93.061044 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 7 (baseline) | 13.875913 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 7 (5.5 weeks) | 40.4564 pg/mL |
| Malignant Tumor Surgery And Radiation | Serum Type 1 Procollagen N-terminal (P1NP) | Subject 7 (18.5 weeks) | 135.28581 pg/mL |