Trial Outcomes & Findings for Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT (NCT NCT03861091)
NCT ID: NCT03861091
Last Updated: 2023-07-27
Results Overview
The primary outcome measure is the percent change in mean cortical thickness (C.Th) of bones receiving 30 Gy or more at 3 months post SBRT, when compared to pre-SBRT cortical thickness
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
At baseline and at 3 months post radiation
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
Risedronate
Risedronate 150 mg given once 7-21 days prior to initiation of SBRT
risedronate: Risedronate 150 mg Oral Given once 7 - 21 days prior to initiation of SBRT
|
Matching Placebo
Matching placebo, dose not applicable given once 7-21 days prior to initiation of SBRT
Matching placebo: Dose not applicable, given once 7-21 days prior to initiation of SBRT
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
43
|
|
Overall Study
COMPLETED
|
41
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT
Baseline characteristics by cohort
| Measure |
Risedronate
n=41 Participants
Risedronate 150 mg given once 7-21 days prior to initiation of SBRT
risedronate: Risedronate 150 mg Oral Given once 7 - 21 days prior to initiation of SBRT
|
Matching Placebo
n=43 Participants
Matching placebo, dose not applicable given once 7-21 days prior to initiation of SBRT
Matching placebo: Dose not applicable, given once 7-21 days prior to initiation of SBRT
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.4 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
71.1 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
71.2 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
43 participants
n=7 Participants
|
84 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline and at 3 months post radiationPopulation: A small number of participants who were enrolled were not able to have cortical thickness determined at 3 months.
The primary outcome measure is the percent change in mean cortical thickness (C.Th) of bones receiving 30 Gy or more at 3 months post SBRT, when compared to pre-SBRT cortical thickness
Outcome measures
| Measure |
Risedronate
n=39 Participants
Risedronate 150 mg given once 7-21 days prior to initiation of SBRT
risedronate: Risedronate 150 mg Oral Given once 7 - 21 days prior to initiation of SBRT
|
Matching Placebo
n=40 Bones
Matching placebo, dose not applicable given once 7-21 days prior to initiation of SBRT
Matching placebo: Dose not applicable, given once 7-21 days prior to initiation of SBRT
|
|---|---|---|
|
Changes in Mean Cortical Thickness
|
4.24 percent change in mm cortical thickne
Standard Error 3.04
|
7.14 percent change in mm cortical thickne
Standard Error 2.93
|
SECONDARY outcome
Timeframe: At baseline, 3 months, 6 months, 9 months and 12 months post radiationPopulation: A small number of participants did not have follow-up cortical thickness measures.
The percent change in mean C.Th of bones will be assessed in regions of bone that received 0 - 10 Gy, \>10 - 20 Gy, \> 20 - 30 Gy, \> 30 - 40 Gy, and \> 40 Gy at all time points including 3 months, 6 months, 9 months, and 12 months.
Outcome measures
| Measure |
Risedronate
n=39 Bones
Risedronate 150 mg given once 7-21 days prior to initiation of SBRT
risedronate: Risedronate 150 mg Oral Given once 7 - 21 days prior to initiation of SBRT
|
Matching Placebo
n=40 Bones
Matching placebo, dose not applicable given once 7-21 days prior to initiation of SBRT
Matching placebo: Dose not applicable, given once 7-21 days prior to initiation of SBRT
|
|---|---|---|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region >40 Gy--time 9mo to bl
|
6.03 percent change in mm cortical thickness
Standard Error 8.53
|
21.37 percent change in mm cortical thickness
Standard Error 7.69
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region <10 Gy--time 3mo to bl
|
13.04 percent change in mm cortical thickness
Standard Error 2.56
|
5.57 percent change in mm cortical thickness
Standard Error 2.50
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region <10 Gy--time 6mo to bl
|
10.37 percent change in mm cortical thickness
Standard Error 2.63
|
5.76 percent change in mm cortical thickness
Standard Error 2.57
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region <10 Gy--time 9mo to bl
|
12.10 percent change in mm cortical thickness
Standard Error 2.71
|
8.07 percent change in mm cortical thickness
Standard Error 2.59
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region <10 Gy--time 12mo to bl
|
11.58 percent change in mm cortical thickness
Standard Error 2.89
|
9.42 percent change in mm cortical thickness
Standard Error 2.70
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region 10-20 Gy--time 3mo to bl
|
9.27 percent change in mm cortical thickness
Standard Error 2.78
|
4.97 percent change in mm cortical thickness
Standard Error 2.72
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region 10-20 Gy--time 6mo to bl
|
6.24 percent change in mm cortical thickness
Standard Error 2.86
|
3.95 percent change in mm cortical thickness
Standard Error 2.82
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region 10-20 Gy--time 9mo to bl
|
7.71 percent change in mm cortical thickness
Standard Error 2.95
|
5.65 percent change in mm cortical thickness
Standard Error 2.82
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region 10-20 Gy--time 12mo to bl
|
10.11 percent change in mm cortical thickness
Standard Error 3.14
|
7.30 percent change in mm cortical thickness
Standard Error 2.94
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region 20-30 Gy--time 3mo to bl
|
8.40 percent change in mm cortical thickness
Standard Error 2.99
|
3.70 percent change in mm cortical thickness
Standard Error 2.87
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region 20-30 Gy--time 6mo to bl
|
5.41 percent change in mm cortical thickness
Standard Error 3.08
|
0.10 percent change in mm cortical thickness
Standard Error 2.95
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region 20-30 Gy--time 9mo to bl
|
6.48 percent change in mm cortical thickness
Standard Error 3.18
|
4.94 percent change in mm cortical thickness
Standard Error 2.95
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region 20-30 Gy--time12mo to bl
|
7.42 percent change in mm cortical thickness
Standard Error 3.36
|
7.23 percent change in mm cortical thickness
Standard Error 3.08
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region 30-40 Gy--time 3mo to bl
|
4.90 percent change in mm cortical thickness
Standard Error 3.22
|
5.20 percent change in mm cortical thickness
Standard Error 3.10
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region 30-40 Gy--time 6mo to bl
|
1.98 percent change in mm cortical thickness
Standard Error 3.31
|
3.21 percent change in mm cortical thickness
Standard Error 3.19
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region 30-40 Gy--time 9mo to bl
|
3.70 percent change in mm cortical thickness
Standard Error 3.43
|
9.64 percent change in mm cortical thickness
Standard Error 3.19
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region 30-40 Gy--time12mo to bl
|
2.23 percent change in mm cortical thickness
Standard Error 3.62
|
11.77 percent change in mm cortical thickness
Standard Error 3.32
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region >30 Gy--time 3mo to bl
|
4.24 percent change in mm cortical thickness
Standard Error 3.04
|
7.14 percent change in mm cortical thickness
Standard Error 2.93
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region >30 Gy--time 6mo to bl
|
1.66 percent change in mm cortical thickness
Standard Error 3.13
|
6.11 percent change in mm cortical thickness
Standard Error 3.01
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region >30 Gy--time 9mo to bl
|
2.12 percent change in mm cortical thickness
Standard Error 3.24
|
10.32 percent change in mm cortical thickness
Standard Error 3.02
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region >30 Gy--time 12mo to bl
|
-0.42 percent change in mm cortical thickness
Standard Error 3.42
|
11.72 percent change in mm cortical thickness
Standard Error 3.14
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region >40 Gy--time 3mo to bl
|
5.83 percent change in mm cortical thickness
Standard Error 8.10
|
12.82 percent change in mm cortical thickness
Standard Error 7.53
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region >40 Gy--time 6mo to bl
|
5.62 percent change in mm cortical thickness
Standard Error 8.41
|
20.30 percent change in mm cortical thickness
Standard Error 7.68
|
|
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
% change cort thickness in region >40 Gy--time 12mo to bl
|
-1.44 percent change in mm cortical thickness
Standard Error 8.92
|
17.17 percent change in mm cortical thickness
Standard Error 8.25
|
SECONDARY outcome
Timeframe: At baseline, 3 months, 6 months, 9 months and 12 months post radiationPopulation: Some participants did not have sufficient self-reported symptom pain data to determine if, over course of 12 months, they had any chest wall pain of grade 3 or higher
Chest wall pain incidence and grade will be collected as per modified CTCAE v. 5 within the within the 50% isodose line. Appendix K. Below we report numbers with any chest wall pain of grades 3+ over the year of followup.
Outcome measures
| Measure |
Risedronate
n=22 Participants
Risedronate 150 mg given once 7-21 days prior to initiation of SBRT
risedronate: Risedronate 150 mg Oral Given once 7 - 21 days prior to initiation of SBRT
|
Matching Placebo
n=28 Participants
Matching placebo, dose not applicable given once 7-21 days prior to initiation of SBRT
Matching placebo: Dose not applicable, given once 7-21 days prior to initiation of SBRT
|
|---|---|---|
|
Number of Participants With Chest Wall Pain
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At 12 months post radiationPopulation: For a small number of participants it was not possible to determine clearly if a fracture had occurred within 12 months.
Incidence of rib and vertebral fractures (as noted on CT imaging) that occur within 12 months of irradiation and are within the within 50% isodose line.
Outcome measures
| Measure |
Risedronate
n=38 Participants
Risedronate 150 mg given once 7-21 days prior to initiation of SBRT
risedronate: Risedronate 150 mg Oral Given once 7 - 21 days prior to initiation of SBRT
|
Matching Placebo
n=39 Participants
Matching placebo, dose not applicable given once 7-21 days prior to initiation of SBRT
Matching placebo: Dose not applicable, given once 7-21 days prior to initiation of SBRT
|
|---|---|---|
|
Number of Participants With Rib and Vertebral Fracture
|
15 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: At 3 months, 6 months, 9 months and 12 months post radiationPopulation: A small number of participants did not have urine samples analyzed.
The urine concentration of an osteoclast-specific biomarker, urinary N-telopeptide (U-NTX) indicating osteoclastic activity will be assessed prior to SBRT and at each routine follow up visit (at 3 months, 6 months, 9 months, and 12 months post SBRT).
Outcome measures
| Measure |
Risedronate
n=38 Participants
Risedronate 150 mg given once 7-21 days prior to initiation of SBRT
risedronate: Risedronate 150 mg Oral Given once 7 - 21 days prior to initiation of SBRT
|
Matching Placebo
n=41 Participants
Matching placebo, dose not applicable given once 7-21 days prior to initiation of SBRT
Matching placebo: Dose not applicable, given once 7-21 days prior to initiation of SBRT
|
|---|---|---|
|
Urine Concentration at 4 Time Points
Urinary NTX values at BL
|
499.3 pg/mL
Standard Deviation 592.0
|
524.9 pg/mL
Standard Deviation 399.4
|
|
Urine Concentration at 4 Time Points
Urinary NTX values at 3mo
|
460.2 pg/mL
Standard Deviation 514.1
|
494.5 pg/mL
Standard Deviation 342.4
|
|
Urine Concentration at 4 Time Points
Urinary NTX values at 6mo
|
669.9 pg/mL
Standard Deviation 955.9
|
350.7 pg/mL
Standard Deviation 301.8
|
|
Urine Concentration at 4 Time Points
Urinary NTX values at 9mo
|
536.1 pg/mL
Standard Deviation 460.0
|
507.0 pg/mL
Standard Deviation 492.2
|
|
Urine Concentration at 4 Time Points
Urinary NTX values at 12mo
|
611.0 pg/mL
Standard Deviation 494.7
|
411.7 pg/mL
Standard Deviation 314.0
|
Adverse Events
Risedronate
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Risedronate
n=41 participants at risk
Risedronate 150 mg given once 7-21 days prior to initiation of SBRT
risedronate: Risedronate 150 mg Oral Given once 7 - 21 days prior to initiation of SBRT
|
Matching Placebo
n=43 participants at risk
Matching placebo, dose not applicable given once 7-21 days prior to initiation of SBRT
Matching placebo: Dose not applicable, given once 7-21 days prior to initiation of SBRT
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/41 • 30 days from the end of all treatments of radiation, up to 12 months.
|
2.3%
1/43 • Number of events 1 • 30 days from the end of all treatments of radiation, up to 12 months.
|
|
Cardiac disorders
Cardiac disorders
|
0.00%
0/41 • 30 days from the end of all treatments of radiation, up to 12 months.
|
2.3%
1/43 • Number of events 1 • 30 days from the end of all treatments of radiation, up to 12 months.
|
Other adverse events
| Measure |
Risedronate
n=41 participants at risk
Risedronate 150 mg given once 7-21 days prior to initiation of SBRT
risedronate: Risedronate 150 mg Oral Given once 7 - 21 days prior to initiation of SBRT
|
Matching Placebo
n=43 participants at risk
Matching placebo, dose not applicable given once 7-21 days prior to initiation of SBRT
Matching placebo: Dose not applicable, given once 7-21 days prior to initiation of SBRT
|
|---|---|---|
|
Cardiac disorders
Atrial flutter
|
2.4%
1/41 • Number of events 1 • 30 days from the end of all treatments of radiation, up to 12 months.
|
0.00%
0/43 • 30 days from the end of all treatments of radiation, up to 12 months.
|
|
General disorders
Fever
|
2.4%
1/41 • Number of events 1 • 30 days from the end of all treatments of radiation, up to 12 months.
|
0.00%
0/43 • 30 days from the end of all treatments of radiation, up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/41 • Number of events 1 • 30 days from the end of all treatments of radiation, up to 12 months.
|
0.00%
0/43 • 30 days from the end of all treatments of radiation, up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
1/41 • Number of events 1 • 30 days from the end of all treatments of radiation, up to 12 months.
|
0.00%
0/43 • 30 days from the end of all treatments of radiation, up to 12 months.
|
|
Nervous system disorders
Stroke
|
2.4%
1/41 • Number of events 1 • 30 days from the end of all treatments of radiation, up to 12 months.
|
0.00%
0/43 • 30 days from the end of all treatments of radiation, up to 12 months.
|
Additional Information
Biostatistician
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-716-5440
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place