Trial Outcomes & Findings for Single Dosing of Zoledronic Acid in Cancer Therapy Induced Bone Loss (CTIBL) (NCT NCT00712985)
NCT ID: NCT00712985
Last Updated: 2014-04-24
Results Overview
17 women with early breast cancer receiving adjuvant Aromatase Inhibitor (AI) therapy were treated with a single 5 mg IV dose of zoledronic acid. Urine and serum NTx and serum CTx were measured at baseline and month 12.
COMPLETED
PHASE3
18 participants
One year
2014-04-24
Participant Flow
Recruitment period was from 1/10/2007 for first patient consented to 12/29/2009 last patient consented. The patients were all seen in the Milton S. Hershey Medical Center Oncology clinic \& were treated from first patient Day 1 of 1/16/2007 to last patient month 12 of 2/01/2011.
Following consent, this trial only had 1 arm \& all patients were given a one time dose of Zoledronic Acid 5 mg IV. All 17 patients were then followed for 12 months from day 1 \& their urine \& serum were collected in order to evaluate the urine N-telopeptide (NTx) \& serum NTx \& C-telopeptide (CTx) levels.
Participant milestones
| Measure |
Zoledronic Acid 5 mg IV
Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 \& every 2 months to month 12 for serum \& urine markers of bone destruction (NTx \& CTx).
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Zoledronic Acid 5 mg IV
Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 \& every 2 months to month 12 for serum \& urine markers of bone destruction (NTx \& CTx).
|
|---|---|
|
Overall Study
1 withdrew prior to start of drug
|
1
|
|
Overall Study
1 patient moved out of state
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
Baseline Characteristics
Single Dosing of Zoledronic Acid in Cancer Therapy Induced Bone Loss (CTIBL)
Baseline characteristics by cohort
| Measure |
Zoledronic Acid 5 mg IV
n=18 Participants
Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 \& every 2 months to month 12 for serum \& urine markers of bone destruction (NTx \& CTx).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 9.89 • n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: One year17 women with early breast cancer receiving adjuvant Aromatase Inhibitor (AI) therapy were treated with a single 5 mg IV dose of zoledronic acid. Urine and serum NTx and serum CTx were measured at baseline and month 12.
Outcome measures
| Measure |
Zoledronic Acid 5 mg IV
n=13 Participants
Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 \& every 2 months to month 12 for serum \& urine markers of bone destruction (NTx \& CTx).
|
|---|---|
|
Number of Participants With Urine and Serum NTx and Serum CTx Within Normal Range at 12 Months
|
13 participants
|
Adverse Events
Zoledronic Acid 5 mg IV
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place