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Last Updated: December 11, 2024

CLINICAL TRIALS PROFILE FOR ZOLEDRONIC ACID


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505(b)(2) Clinical Trials for Zoledronic Acid

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
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 >Phase >Start Date >Summary

All Clinical Trials for Zoledronic Acid

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zoledronic Acid

Condition Name

Condition Name for Zoledronic Acid
Intervention Trials
Osteoporosis 51
Breast Cancer 40
Prostate Cancer 27
Multiple Myeloma 17
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Condition MeSH

Condition MeSH for Zoledronic Acid
Intervention Trials
Osteoporosis 74
Breast Neoplasms 58
Neoplasm Metastasis 51
Prostatic Neoplasms 44
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Clinical Trial Locations for Zoledronic Acid

Trials by Country

Trials by Country for Zoledronic Acid
Location Trials
United States 854
United Kingdom 76
Canada 71
Germany 58
Australia 46
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Trials by US State

Trials by US State for Zoledronic Acid
Location Trials
California 44
New York 40
Pennsylvania 37
Florida 32
Texas 29
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Clinical Trial Progress for Zoledronic Acid

Clinical Trial Phase

Clinical Trial Phase for Zoledronic Acid
Clinical Trial Phase Trials
Phase 4 72
Phase 3 88
Phase 2/Phase 3 11
[disabled in preview] 69
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Clinical Trial Status

Clinical Trial Status for Zoledronic Acid
Clinical Trial Phase Trials
Completed 172
Terminated 36
Recruiting 35
[disabled in preview] 19
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Clinical Trial Sponsors for Zoledronic Acid

Sponsor Name

Sponsor Name for Zoledronic Acid
Sponsor Trials
Novartis Pharmaceuticals 69
Novartis 48
National Cancer Institute (NCI) 22
[disabled in preview] 12
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Sponsor Type

Sponsor Type for Zoledronic Acid
Sponsor Trials
Other 303
Industry 177
NIH 35
[disabled in preview] 7
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