Trial Outcomes & Findings for Using TRAP to Evaluate the Effect of Zometa on Bone Metastasis Due to Lung Cancer (NCT NCT00265200)

Results Overview

Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

TRAP levels at Baseline and 2 weeks after first Zometa infusion

Results posted on

2018-03-05

Participant milestones
Measure	Zoledronic Acid 3.0-4.0 mg by IV (in the vein), once a month for 6 months
Overall Study STARTED	28
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	4

Withdrawal data not reported

Using TRAP to Evaluate the Effect of Zometa on Bone Metastasis Due to Lung Cancer

Baseline characteristics by cohort
Measure	Zoledronic Acid n=28 Participants 3.0-4.0 mg by IV (in the vein), once a month for 6 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

Timeframe: TRAP levels at Baseline and 2 weeks after first Zometa infusion

Population: 13 of 28 total study participants could not be evaluated: 7 due to sample deterioration; 5 participant non-compliance; 1 withdrew.

Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline

Outcome measures
Measure	Zoledronic Acid n=15 Participants 3.0-4.0 mg by IV (in the vein), once a month for 6 months
Average Percent Change From Baseline in TRAP Levels at 2 Weeks NTx	37.3 Percent change Interval 37.0 to 38.0
Average Percent Change From Baseline in TRAP Levels at 2 Weeks TRAP-5b	44.9 Percent change Interval 44.0 to 45.0
Average Percent Change From Baseline in TRAP Levels at 2 Weeks bALP	12.9 Percent change Interval 12.0 to 13.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

James Graham Brown Cancer Center, University of Louisville

Phone: 502-562-4358