Trial Outcomes & Findings for Study of Zoledronic Acid Versus Observation on Bone Mineral Density and Incidence of Micrometastasis in Women Undergoing Pelvic Radiation for Cervical Cancer (NCT NCT00966992)
NCT ID: NCT00966992
Last Updated: 2015-09-09
Results Overview
TERMINATED
PHASE2
3 participants
At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment
2015-09-09
Participant Flow
The study opened to participant enrollment on 08/12/2009 and closed to participant enrollment on 08/31/2010.
Participant milestones
| Measure |
Arm 1 (No Zometa)
Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
|
Arm 2 (Zometa)
Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
Zoledronic acid
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Zoledronic Acid Versus Observation on Bone Mineral Density and Incidence of Micrometastasis in Women Undergoing Pelvic Radiation for Cervical Cancer
Baseline characteristics by cohort
| Measure |
Arm 1 (No Zometa)
n=3 Participants
Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
|
Arm 2 (Zometa)
Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
Zoledronic acid
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 participants
n=99 Participants
|
—
|
2 participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 participants
n=99 Participants
|
—
|
1 participants
n=206 Participants
|
|
Gender
Female
|
3 participants
n=99 Participants
|
—
|
3 participants
n=206 Participants
|
|
Gender
Male
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
—
|
3 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatmentPopulation: This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatmentPopulation: This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the time of diagnosis and 9 months after completion of treatmentPopulation: This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the time of diagnosis and 9 months after completion of treatmentPopulation: This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At diagnosis, 6 months after completion of treatment, and 9 months after completion of treatmentPopulation: This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months after completion of treatment and 9 months after completion of treatmentPopulation: This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 (No Zometa)
Arm 2 (Zometa)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1 (No Zometa)
n=3 participants at risk
Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
|
Arm 2 (Zometa)
Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
33.3%
1/3
|
—
0/0
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3
|
—
0/0
|
|
Investigations
Hemoglobin
|
33.3%
1/3
|
—
0/0
|
|
Investigations
Leukocytes (WBC)
|
33.3%
1/3
|
—
0/0
|
|
Reproductive system and breast disorders
Vaginal discharge
|
33.3%
1/3
|
—
0/0
|
|
Reproductive system and breast disorders
Pelvis pain
|
33.3%
1/3
|
—
0/0
|
Additional Information
Perry Grigsby, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place