Trial Outcomes & Findings for Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss (NCT NCT00352846)

Results Overview

The 12-month change from baseline in BMD at the total lumbar spine. BMD evaluation was performed at baseline and at 12 months after initiation of therapy at the lumbar spine. BMD was measured by dual-energy, x-ray absorptiometry scanners. T-Score is the number of standard deviations above or below the mean. A T-score \>= -1 indicates a normal BMD, while T-scores between -1 and -2.5 indicate osteopenia and T-scores \<= -2.5 indicate osteoporosis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

135 participants

Primary outcome timeframe

From baseline to 12 Months

Results posted on

2013-07-02

Participant Flow

Recruitment Period: 01/27/2006 to 08/13/2009. All recruitments done at UT MD Anderson Cancer Center.

Of 135 enrolled participants, 61 were excluded from the trial before assignment to groups due to screen failures.

Participant milestones

Participant milestones
Measure	Vitamin D + Calcium Carbonate Oral Vitamin D 400 mg daily + Calcium 1200 mg daily	Vitamin D + Calcium Carbonate + Zoledronic Acid Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m\^2 intravenous at baseline and 6 months.
Overall Study STARTED	37	37
Overall Study COMPLETED	29	24
Overall Study NOT COMPLETED	8	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Vitamin D + Calcium Carbonate Oral Vitamin D 400 mg daily + Calcium 1200 mg daily	Vitamin D + Calcium Carbonate + Zoledronic Acid Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m\^2 intravenous at baseline and 6 months.
Overall Study Disease progression	0	2
Overall Study Withdrawal by Subject	3	8
Overall Study Ineligible	3	2
Overall Study Non-compliance	2	0
Overall Study Death	0	1

Baseline Characteristics

Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D + Calcium Carbonate n=37 Participants Oral Vitamin D 400 mg daily + Calcium 1200 mg daily	Vitamin D + Calcium Carbonate + Zoledronic Acid n=37 Participants Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m\^2 intravenous at baseline and 6 months.	Total n=74 Participants Total of all reporting groups
Age Continuous	57 years n=5 Participants	61 years n=7 Participants	57 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	37 participants n=7 Participants	74 participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to 12 Months

Population: BMD data available on 53 evaluable participants upon treatment completion.

The 12-month change from baseline in BMD at the total lumbar spine. BMD evaluation was performed at baseline and at 12 months after initiation of therapy at the lumbar spine. BMD was measured by dual-energy, x-ray absorptiometry scanners. T-Score is the number of standard deviations above or below the mean. A T-score \>= -1 indicates a normal BMD, while T-scores between -1 and -2.5 indicate osteopenia and T-scores \<= -2.5 indicate osteoporosis.

Outcome measures

Outcome measures
Measure	Vitamin D + Calcium Carbonate n=29 Participants Oral Vitamin D 400 mg daily + Calcium 1200 mg daily	Vitamin D + Calcium Carbonate + Zoledronic Acid n=24 Participants Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m\^2 intravenous at baseline and 6 months.
Percentage Change in Bone Mineral Density (BMD) T-Score From Baseline to 12 Months	0.08 Percentage Change of BMD Standard Deviation 0.34	-0.09 Percentage Change of BMD Standard Deviation 1.23

Adverse Events

Vitamin D + Calcium Carbonate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin D + Calcium Carbonate + Zoledronic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Fredrick Hagemeister, MD/Professor

The University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place