Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00365105 · ClinicalTrials.gov registry record · Phase 3
Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer
A Phase 3 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 261
- Enrollment target
NCT00365105: Completed Phase 3 study, sponsored by Radiation Therapy Oncology Group.
NCT00365105 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 261 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00365105, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 261 participants
- Enrollment target
Study Summary
RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other symptoms caused by bone metastases. It is not yet known whether giving zoledronate together with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in treating patients with bone metastases from prostate cancer, lung cancer, or breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate, vitamin D, and calcium to see how well they work compared to zoledronate, vitamin D, calcium, and either strontium 89 or samarium 153 in preventing or delaying bone problems in patients with bone metastases from prostate cancer, lung cancer, or breast cancer.
Primary Outcome
Median time to development of a malignant skeletal related event (SRE), which is defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone is estimated using Kaplan-Meier method. The time of failure was measured from date of randomization to the date of a documented SRE. The analysis was planned to occur after 257 SRE have been observed, unless the criteria for early stopping are met.
Interventions
- DIETARY_SUPPLEMENT Vitamin D
- DRUG zoledronic acid
- DIETARY_SUPPLEMENT Calcium
- DRUG Sm-153
- RADIATION Sr-89
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2006-07-11 |
| Est. Completion | 2017-02-27 |
| Phase | Phase 3 |
What the finished NCT00365105 record still lists
NCT00365105 is an interventional study that assigns participants to a tested intervention. The registered 261 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 5 interventions - of which Vitamin D is the first listed.
NCT00365105 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00365105 about?
NCT00365105 is a clinical study titled "Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer". RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other symptoms caused by bone metastases. It is not yet known whether giving zoledronate together with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in treating patients with bone ...
What is the current status of trial NCT00365105?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 261 participants. The study started on 2006-07-11. Estimated completion is 2017-02-27.
What interventions are being tested in trial NCT00365105?
The interventions under investigation include: Vitamin D (DIETARY_SUPPLEMENT), zoledronic acid (DRUG), Calcium (DIETARY_SUPPLEMENT), Sm-153 (DRUG), Sr-89 (RADIATION).
Who is sponsoring clinical trial NCT00365105?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00365105's enrollment target sits among peer trials
261 1228th of 2000 higher than 771 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05124912 · 261 participants · NA
REMASTer: REcurrent Brain Metastases After SRS Trial
- NCT06559891 · 261 participants · NA
THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension
- NCT03713268 · 262 participants
Intraoperative OCT Guidance of Intraocular Surgery II
- NCT06074380 · 262 participants · Phase 4
Non Inferiority Trial Investigating Surfactants Administered Via MIST
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI