Trial Outcomes & Findings for Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries (NCT NCT00305695)
NCT ID: NCT00305695
Last Updated: 2020-03-24
Results Overview
To compare the effect of zoledronic acid administered every 6 months on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries), as compared with observation alone. This is to be evaluated by measuring the change from baseline to 9 months in bone mineral density (BMD) of the lumbar spine, specifically L1-L4 dual energy X-ray absorptiometry (DEXA).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
9 Months
Results posted on
2020-03-24
Participant Flow
GOG 0215 accrued 160 patients from November 2005 to April 2010.
Participant milestones
| Measure |
Arm I (Zoledroic Acid)
Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
Laboratory Biomarker Analysis: Correlative studies
Zoledronic Acid: Given IV
|
Arm II (Clinical Observation)
Patients are observed for 18 months after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
79
|
|
Overall Study
COMPLETED
|
40
|
52
|
|
Overall Study
NOT COMPLETED
|
41
|
27
|
Reasons for withdrawal
| Measure |
Arm I (Zoledroic Acid)
Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
Laboratory Biomarker Analysis: Correlative studies
Zoledronic Acid: Given IV
|
Arm II (Clinical Observation)
Patients are observed for 18 months after surgery.
|
|---|---|---|
|
Overall Study
Withdrawal by subject prior to 18 month
|
40
|
26
|
|
Overall Study
Did not have baseline scan
|
1
|
1
|
Baseline Characteristics
Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries
Baseline characteristics by cohort
| Measure |
Arm I (Zoledroic Acid)
n=80 Participants
Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
Laboratory Biomarker Analysis: Correlative studies
Zoledronic Acid: Given IV
|
Arm II (Clinical Observation)
n=78 Participants
Patients are observed for 18 months after surgery.
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
20-29 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Customized
30-39 years
|
9 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Age, Customized
40-49 years
|
57 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Age, Customized
50-59 years
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 9 MonthsPopulation: Eligible and Treated Patients
To compare the effect of zoledronic acid administered every 6 months on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries), as compared with observation alone. This is to be evaluated by measuring the change from baseline to 9 months in bone mineral density (BMD) of the lumbar spine, specifically L1-L4 dual energy X-ray absorptiometry (DEXA).
Outcome measures
| Measure |
Arm I (Zoledroic Acid)
n=51 Participants
Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
Laboratory Biomarker Analysis: Correlative studies
Zoledronic Acid: Given IV
|
Arm II (Clinical Observation)
n=68 Participants
Patients are observed for 18 months after surgery.
|
|---|---|---|
|
Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 9 Months
|
-0.025 g/cm2
Interval -0.24 to 0.077
|
-0.086 g/cm2
Interval -0.308 to 0.067
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Eligible and Treated Patients
To compare the effect of zoledronic acid administered every 6 months on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries), as compared with observation alone. This is to be evaluated by measuring the change from baseline to 18 months in bone mineral density (BMD) of the lumbar spine, specifically L1-L4 dual energy X-ray absorptiometry (DEXA).
Outcome measures
| Measure |
Arm I (Zoledroic Acid)
n=40 Participants
Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
Laboratory Biomarker Analysis: Correlative studies
Zoledronic Acid: Given IV
|
Arm II (Clinical Observation)
n=52 Participants
Patients are observed for 18 months after surgery.
|
|---|---|---|
|
Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 18 Months
|
-0.001 g/cm2
Interval -0.199 to 0.093
|
-0.094 g/cm2
Interval -0.349 to 0.28
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Eligible and Treated patients
To compare the effect of zoledronic acid on the change in BMD of the right hip following treatment, evaluated by measuring the change from baseline to 18 months
Outcome measures
| Measure |
Arm I (Zoledroic Acid)
n=35 Participants
Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
Laboratory Biomarker Analysis: Correlative studies
Zoledronic Acid: Given IV
|
Arm II (Clinical Observation)
n=51 Participants
Patients are observed for 18 months after surgery.
|
|---|---|---|
|
Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Right Hip
|
0.101 g/cm2
Interval -0.4 to 1.5
|
-0.052 g/cm2
Interval -0.212 to 0.307
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Eligible and Treated patients
To compare the effect of zoledronic acid on the change in BMD of the left hip following treatment, evaluated by measuring the change from baseline to 18 months
Outcome measures
| Measure |
Arm I (Zoledroic Acid)
n=40 Participants
Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
Laboratory Biomarker Analysis: Correlative studies
Zoledronic Acid: Given IV
|
Arm II (Clinical Observation)
n=54 Participants
Patients are observed for 18 months after surgery.
|
|---|---|---|
|
Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Left Hip
|
-0.003 g/cm2
Interval -0.142 to 0.067
|
-0.058 g/cm2
Interval -0.185 to 0.009
|
Adverse Events
Arm I (Zoledroic Acid)
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
Arm II (Clinical Observation)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Zoledroic Acid)
n=80 participants at risk
Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
Laboratory Biomarker Analysis: Correlative studies
Zoledronic Acid: Given IV
|
Arm II (Clinical Observation)
n=78 participants at risk
Patients are observed for 18 months after surgery.
|
|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
Other adverse events
| Measure |
Arm I (Zoledroic Acid)
n=80 participants at risk
Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
Laboratory Biomarker Analysis: Correlative studies
Zoledronic Acid: Given IV
|
Arm II (Clinical Observation)
n=78 participants at risk
Patients are observed for 18 months after surgery.
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
2.5%
2/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
General disorders
Fever
|
15.0%
12/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
General disorders
Rigors/Chills
|
17.5%
14/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
General disorders
Fatigue
|
27.5%
22/80 • Up to 18 months
|
5.1%
4/78 • Up to 18 months
|
|
General disorders
Insomnia
|
0.00%
0/80 • Up to 18 months
|
5.1%
4/78 • Up to 18 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
1/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
Endocrine disorders
Hot Flashes
|
3.8%
3/80 • Up to 18 months
|
7.7%
6/78 • Up to 18 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
Gastrointestinal disorders
Taste Alteration
|
1.2%
1/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
6/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
Gastrointestinal disorders
Anorexia
|
2.5%
2/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
Gastrointestinal disorders
Constipation
|
2.5%
2/80 • Up to 18 months
|
3.8%
3/78 • Up to 18 months
|
|
Gastrointestinal disorders
Nausea
|
18.8%
15/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
1.2%
1/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
1/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
0.00%
0/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
Infections and infestations
Inf Unknown Anc: Sinus
|
0.00%
0/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
Blood and lymphatic system disorders
Edema: Limb
|
1.2%
1/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
Metabolism and nutrition disorders
Creatinine
|
1.2%
1/80 • Up to 18 months
|
2.6%
2/78 • Up to 18 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.2%
1/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.5%
2/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
Nervous system disorders
Mental Status
|
1.2%
1/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
Nervous system disorders
Mood Alteration - Depression
|
0.00%
0/80 • Up to 18 months
|
3.8%
3/78 • Up to 18 months
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
0.00%
0/80 • Up to 18 months
|
2.6%
2/78 • Up to 18 months
|
|
Nervous system disorders
Dizziness
|
1.2%
1/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
Nervous system disorders
Neuropathy-Sensory
|
1.2%
1/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
General disorders
Pain - Other
|
1.2%
1/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
General disorders
Pain: Pelvis
|
0.00%
0/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
General disorders
Pain: Vagina
|
1.2%
1/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
General disorders
Pain: Chest /Thorax Nos
|
1.2%
1/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
General disorders
Pain: Head/Headache
|
7.5%
6/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
General disorders
Pain: Neck
|
2.5%
2/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
General disorders
Pain: Extremity-Limb
|
0.00%
0/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
General disorders
Pain: Back
|
2.5%
2/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
General disorders
Pain: Joint
|
25.0%
20/80 • Up to 18 months
|
5.1%
4/78 • Up to 18 months
|
|
General disorders
Pain: Bone
|
16.2%
13/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
General disorders
Pain: Abdominal Pain Nos
|
2.5%
2/80 • Up to 18 months
|
2.6%
2/78 • Up to 18 months
|
|
General disorders
Pain: External Ear
|
1.2%
1/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
General disorders
Pain: Muscle
|
23.8%
19/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.2%
1/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
|
Renal and urinary disorders
Incontinence, Urinary
|
0.00%
0/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/80 • Up to 18 months
|
1.3%
1/78 • Up to 18 months
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
2.5%
2/80 • Up to 18 months
|
3.8%
3/78 • Up to 18 months
|
|
General disorders
Flu-Like Syndrome
|
3.8%
3/80 • Up to 18 months
|
0.00%
0/78 • Up to 18 months
|
Additional Information
Linda Gedeon on behalf of James Kauderer, MA, BS
NRG Oncology
Phone: 716-845-1169
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60