Trial Outcomes & Findings for Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation (NCT NCT00058188)
NCT ID: NCT00058188
Last Updated: 2020-12-08
Results Overview
To assess bone density change as measured by dual-energy x-ray absorptiometry
TERMINATED
PHASE3
53 participants
Bone scan taken at baseline and month 13
2020-12-08
Participant Flow
PIs departure from the institution was sudden and due unforeseen serious circumstances. Due to this, no data was collected for this study nor can be reported on.
Participant milestones
| Measure |
Treatment With Zoledronate, Calcium and Cholecalciferol
Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.
cholecalciferol: Given orally
calcium gluconate: Given orally
zoledronic acid: Given IV
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Treatment With Calcium and Cholecalciferol
Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.
cholecalciferol: Given orally
calcium gluconate: Given orally
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Overall Study
STARTED
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0
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Bone scan taken at baseline and month 13Population: Due to the unique situation of the PI, no data was collected for this study nor can be reported on.
To assess bone density change as measured by dual-energy x-ray absorptiometry
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Lumbar spine and hip bone density taken at baseline and month 13.Population: Due to the unique situation of the PI, no data was collected for this study nor can be reported on.
To assess the percentage change in lumbar spine and hip bone density as measured by plain film x-rays of lumbar spine and pelvis
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Bone alkaline phosphatase taken at baseline, month 6 and month 13.Population: Due to the unique situation of the PI, no data was collected for this study nor can be reported on.
To assess markers of bone formation and resorption.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PSA taken at baseline, month 3, month 6, month 9, month 12 and month 13. CT scan of abdomen and pelvis taken at baseline and month 13. Serum testosterone, estradiol, parathyroid taken at baseline, month 6 and month 13.Population: Due to the unique situation of the PI, no data was collected for this study nor can be reported on.
To assess the incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Serum osteocalcin and serum bone alkaline phosphatase taken at baseline, month 6 and month 13.Population: Due to the unique situation of the PI, no data was collected for this study nor can be reported on.
To assess the incidence of new or progressive bone metastatic disease
Outcome measures
Outcome data not reported
Adverse Events
Treatment With Zoledronate, Calcium and Cholecalciferol
Treatment With Calcium and Cholecalciferol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Trials Office
Northwestern University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place