CLINICAL TRIALS PROFILE FOR ZOLEDRONIC
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505(b)(2) Clinical Trials for Zoledronic
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT00145275 ↗ | To Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Post-menopausal Women | Completed | Novartis | Phase 3 | 2004-12-01 | Zoledronic acid is a medicine being studied in people with low bone mass. Side effects such as headache, fever, muscle aches, and pains, may occur following the infusion. This study will investigate the use of over-the-counter medicines to improve these symptoms. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Zoledronic
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00022087 ↗ | Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer | Completed | National Cancer Institute (NCI) | Phase 3 | 2001-12-01 | RATIONALE: Zoledronate plus calcium and vitamin D may prevent bone loss in patients receiving adjuvant chemotherapy for breast cancer. It is not yet known which regimen is more effective in preventing bone loss. PURPOSE: This randomized phase III trial is comparing two regimens of zoledronate plus calcium and vitamin D to see how well they work in preventing bone loss in women who are receiving adjuvant chemotherapy for breast cancer. |
| NCT00022087 ↗ | Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer | Completed | Alliance for Clinical Trials in Oncology | Phase 3 | 2001-12-01 | RATIONALE: Zoledronate plus calcium and vitamin D may prevent bone loss in patients receiving adjuvant chemotherapy for breast cancer. It is not yet known which regimen is more effective in preventing bone loss. PURPOSE: This randomized phase III trial is comparing two regimens of zoledronate plus calcium and vitamin D to see how well they work in preventing bone loss in women who are receiving adjuvant chemotherapy for breast cancer. |
| NCT00029224 ↗ | Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions | Completed | Novartis | Phase 4 | 2001-10-01 | Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or prostate cancer will be treated with IV Zometa in a 15 minute infusion. Pain will be evaluated, as well as time in chair, quality of life and safety of Zometa. |
| NCT00035997 ↗ | Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis | Completed | Novartis Pharmaceuticals | Phase 4 | 2002-04-01 | The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy. This trial will seek to determine the effect of ZOMETA in stabilizing and increasing bone mineral density in these patients. This prospective, open-label, single arm, multicenter study will enroll approximately 200 prostate cancer patients with a history of at least one documented bone lesion documented by bone scan or radiograph. Patients must already be receiving hormone therapy and meet the following additional criteria: - 18 years of age or older - Histologically confirmed diagnoses of prostate cancer - Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or radiograph - Received or will receive hormonal treatment also know as androgen deprivation therapy with an LHRH agonist or other hormonal treatments Throughout the course of this 12-month trial, patients will be identified based on the duration of established hormonal treatment at the time of enrollment. Each patients duration of participation will be up to 56 weeks including a 4 week screening, 48 week treatment and a 4 week follow up. |
| NCT00039104 ↗ | Zoledronate and BMS-275291 in Treating Patients With Prostate Cancer | Completed | National Cancer Institute (NCI) | Phase 2 | 2002-04-01 | Phase II trial to study the effectiveness of combining zoledronate with BMS-275291 in treating patients who have prostate cancer that has not responded to previous hormone therapy. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. BMS-275291 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Combining zoledronate with BMS-275291 may kill more tumor cells. |
| NCT00046254 ↗ | Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture | Completed | Novartis Pharmaceuticals | Phase 3 | 2002-02-01 | The purpose of this study is to evaluate whether zoledronic acid given once yearly for two years to men and women after surgical repair of a recent hip fracture will significantly reduce the rate of all re-occurring (new) osteoporotic fractures. All patients will receive vitamin D and calcium. |
| NCT00049452 ↗ | Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer | Completed | National Cancer Institute (NCI) | Phase 3 | 2001-12-01 | RATIONALE: It is not yet known whether zoledronate is effective in preventing bone loss in premenopausal women who are receiving adjuvant chemotherapy after undergoing surgery for early stage breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in preventing bone loss in premenopausal women who are receiving chemotherapy after surgery for early stage breast cancer. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for Zoledronic
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