Zometa

(Zoledronic acid)

ApprovedSmall molecule

Zoledronic acid is used to treat bone loss and prevent bone fractures in patients with osteoporosis, and to manage bone problems caused by cancer and high calcium levels in the blood.[2] Zometa is currently approved and in use across 51 indications[4].[1]

Zometa is one of 928 small molecule programs targeting Multiple Myeloma. It is currently in Approved.

Indications

262

Total Trials

Active Trials

927

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Multiple MyelomaWithdrawn

Non-Small Cell Lung CancerCompleted

Prostate CarcinomaActive, not recruiting

HypercalcemiaActive, not recruiting

MetastasisActive, not recruiting

Paget DiseaseActive, not recruiting

Osteitis DeformansActive, not recruiting

StrokeActive, not recruiting

Prostate AdenocarcinomaApproved

Plasma Cell NeoplasmApproved

Multiple MyelomaApproved

Withdrawn

Non-Small Cell Lung CancerApproved

Completed

Prostate CarcinomaApproved

Active, not recruiting

HypercalcemiaApproved

Active, not recruiting

MetastasisApproved

Active, not recruiting

Paget DiseaseApproved

Active, not recruiting

Osteitis DeformansApproved

Active, not recruiting

StrokePreclinical

Active, not recruiting

Prostate AdenocarcinomaApproved

Approved

Plasma Cell NeoplasmApproved

Approved

Showing 10 of 50 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Zometa

Pfizer

Approved

33 2

Adenocard

Astellas

Preclinical

2 3

Zolymbus

AbbVie

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 5

Duragesic-100

CCephalon

Preclinical

2 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 7

Spravato

WWim Janssens

Preclinical

2 8

Tricor

JJagotec

Preclinical

1 9

Acupan

YYonsei University

Preclinical

1 10

Chantix

PPrism Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Post-ApprovalActive, not recruiting

ILD

NCT05058976

Q3 2027

Phase 1/2Recruiting

Anemia

NCT07471516

Q4 2027

Phase 2Active, not recruiting

Pancreatic Cancer

NCT03073785

Q1 2028

Phase 3Recruiting

Giant Cell Tumor

NCT03295981

Clinical

Trials by Indication[1]

Breast Cancer28 trials

Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy

Completed· Novartis logo

Novartis·Phase 3·NCT00050011·602 enrolled

Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid

Terminated·—·N/A·NCT01409811·9 enrolled

Zoledronate in Treating Bone Marrow Micrometastases in Women With Stage I, Stage II, or Stage III Breast Cancer

Completed·UUniversity of California, San Francisco·Phase 2·NCT00295867·45 enrolled

Show 25 more trials

Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT00332709·83 enrolled

Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy

Completed· Amgen logo

Amgen·Phase 3·NCT00556374·3,420 enrolled

Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer

Completed·HHerbert Irving Comprehensive Cancer Center·Phase 3·NCT00049452·120 enrolled

The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT00171314·527 enrolled

Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00558272·139 enrolled

Comparison of Two Schedules of Zoledronic Acid in Treating Patients With Breast Cancer That Has Spread to the Bone

Terminated·UUniversity of Leeds·N/A·NCT00458796·1,500 enrolled

Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer

Unknown status·—·Phase 3·NCT00072020

The ODYSSEY TRIAL Phase IV Trial Evaluating the Palliative Benefit of Pamidronate or Zoledronic Acid in Breast Cancer

Completed·OOttawa Hospital Research Institute·Phase 4·NCT01907880·74 enrolled

Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00022087·439 enrolled

Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT00320710·416 enrolled

HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.

Unknown status·NNational Cancer Institute, Naples·Phase 3·NCT00412022·1,294 enrolled

Postoperative Use of Zoledronic Acid in Breast Cancer Patients After Neoadjuvant Chemotherapy

Completed·GGBG Forschungs GmbH·Phase 3·NCT00512993·654 enrolled

Neo-Adjuvant Chemotherapy (TAC) With or Without Zoledronic Acid in Treating HER2-negative Breast Cancer Patients

Completed·BBorstkanker Onderzoek Groep·Phase 3·NCT01099436·250 enrolled

Safety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions

Terminated· Novartis logo

Novartis·Phase 3·NCT00372710·30 enrolled

Zoledronate in Preventing Bone Loss in Postmenopausal Women Who Are Receiving Letrozole for Stage I, Stage II, or Stage IIIA Breast Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00107263·558 enrolled

Effect of Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients

Completed· Novartis logo

Novartis·Phase 4·NCT01129336·44 enrolled

Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer

Completed·MMayo Clinic·N/A·NCT00436917·60 enrolled

Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions

Terminated·SSpanish Breast Cancer Research Group·Phase 3·NCT00130494·97 enrolled

Safety and Efficacy of Zoledronic Acid in Patients With Breast Cancer With Metastatic Bone Lesions

Completed· Novartis logo

Novartis·Phase 3·NCT00375427·430 enrolled

Effectiveness of Zoledronic Acid in the Prevention of Osteoporosis in Early Breast Cancer Patients Receiving Letrozole

Completed·SSoroka University Medical Center·Phase 3·NCT00376740·90 enrolled

Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Patients With Metastatic Breast Cancer: Duration of Effect

Completed·UUniversity Health Network, Toronto·Phase 2/3·NCT01344967·21 enrolled

S0307A, Long-Term Bone Quality in Women With Breast Cancer Enrolled on Clinical Trial SWOG-S0307

Withdrawn·SSWOG Cancer Research Network··NCT00873808

Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.

Completed· Novartis logo

Novartis·Phase 3·NCT00171340·1,065 enrolled

S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.

Completed·SSWOG Cancer Research Network·Phase 3·NCT00127205·6,097 enrolled

Extended Endocrine Therapy for Premenopausal Women With Breast Cancer

Completed·—·Phase 2·NCT00903162·17 enrolled

Prostate Cancer20 trials

The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

Completed· Novartis logo

Novartis·Phase 4·NCT00063609·200 enrolled

Calcitriol and Zoledronate in Treating Patients With Progressive Prostate Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT00004928

Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients

Completed·MMerrion Pharmaceuticals, LLC·Phase 2·NCT00636740·30 enrolled

Show 17 more trials

Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases

Completed· Novartis logo

Novartis·Phase 4·NCT00219219

Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00081159·80 enrolled

Luteinizing Hormone-releasing Hormone Analogue and Enzalutamide +/- Zoledronic Acid in Prostate Cancer Patients

Completed·AAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia·Phase 2·NCT03336983·126 enrolled

Adjuvant Docetaxel-Zoledronic Acid in High-risk Early Prostate Cancer Following Prostatectomy.

Terminated· Novartis logo

Novartis·Phase 2·NCT00258765·1 enrolled

Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer

Completed· Novartis logo

Novartis·Phase 4·NCT00219271·60 enrolled

Androgen Blockade Therapy With or Without Zoledronic Acid in Treating Patients With Prostate Cancer and Bone Metastases

Completed·TTranslational Research Center for Medical Innovation, Kobe, Hyogo, Japan·Phase 3·NCT00685646·227 enrolled

Maintaining Bone Strength in Men With Prostate Cancer

Terminated· Novartis logo

Novartis·Phase 3·NCT00391950·300 enrolled

Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer

Completed·WWirral University Teaching Hospital NHS Trust·N/A·NCT00520052·58 enrolled

Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT00375648·61 enrolled

ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer

Completed·NNational Cancer Institute, Naples·Phase 1·NCT00415779·36 enrolled

Zoledronate Plus Standard Therapy Compared With Placebo Plus Standard Therapy to Prevent Bone Metastases in Patients With Recurrent Prostate Cancer That Has No Symptoms

Terminated· Novartis logo

Novartis·Phase 3·NCT00005073·544 enrolled

Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00079001·645 enrolled

Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer

Terminated·SStanford University·Phase 2·NCT00226954·23 enrolled

A Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy

Completed· Novartis logo

Novartis·N/A·NCT00087659

Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer

Completed·MMassachusetts General Hospital·Phase 2·NCT00181584·60 enrolled

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer

Completed· Amgen logo

Amgen·Phase 3·NCT00321620·1,904 enrolled

Atrasentan and Zometa for Men With Prostate Cancer Metastatic to Bone

Completed·MMassachusetts General Hospital·Phase 2·NCT00181558·44 enrolled

Multiple Myeloma17 trials

Efficacy and Safety of Zoledronic Acid in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma

Completed· Novartis logo

Novartis·Phase 3·NCT00219258·240 enrolled

Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions

Completed· Novartis logo

Novartis·Phase 4·NCT00029224·500 enrolled

A Multiple Myeloma Trial in Patients With Bone Metastases

Completed· Novartis logo

Novartis·Phase 4·NCT00104104·179 enrolled

Show 14 more trials

Study of Zoledronic Acid Administered Monthly Versus Every 3 Months in Multiple Myeloma and Breast Cancer Patients Who Were Treated With Zoledronic Acid the Prior Year

Completed· Novartis logo

Novartis·Phase 1·NCT00424983·18 enrolled

Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma

Completed· Amgen logo

Amgen·Phase 3·NCT01345019·1,718 enrolled

Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma

Terminated·HHoosier Cancer Research Network·Phase 2·NCT00216151·3 enrolled

Samarium Sm 153 Lexidronam Pentasodium Combined With Zoledronic Acid or Pamidronate in Treating Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain

Completed·MMayo Clinic·Phase 1/2·NCT00482378·39 enrolled

Zoledronate With or Without Thalidomide in Treating Patients With Early Stage Multiple Myeloma

Completed·MMayo Clinic·Phase 3·NCT00432458·68 enrolled

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.

Completed· Amgen logo

Amgen·Phase 3·NCT00330759·1,779 enrolled

Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma

Completed·—·Phase 2·NCT00263484·56 enrolled

Prolonged Protection From Bone Disease in Multiple Myeloma

Completed·TThomas Lund·Phase 4·NCT02286830·158 enrolled

Open-label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.

Withdrawn· Novartis logo

Novartis·Phase 4·NCT00242528

Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants

Completed· Novartis logo

Novartis·Phase 4·NCT00622505·121 enrolled

THAL-DEX Incorporated Into Double PBSC Autotransplantation for Untreated Multiple Myeloma (MM)

Completed·IIRCCS Azienda Ospedaliero-Universitaria di Bologna·Phase 2·NCT01341262·378 enrolled

Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I

Terminated· Novartis logo

Novartis·Phase 3·NCT00171925·143 enrolled

Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse

Completed·PPETHEMA Foundation·Phase 4·NCT01087008·103 enrolled

Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

Completed·MMassachusetts General Hospital·Phase 2·NCT00577642·29 enrolled

Osteoporosis11 trials

Efficacy of Zoledronic Acid in Osteoporosis of Children With Multiple Disabilities

Completed·—··NCT03301285·60 enrolled

Efficacy And Security Of Annual And Biennial Zoledronic Acid For Osteoporosis Treatment In An HIV-Infected Patients' Cohort

Completed·GGermans Trias i Pujol Hospital·Phase 4·NCT00795483·33 enrolled

Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis

Completed· Novartis logo

Novartis·Phase 3·NCT00100620·802 enrolled

Show 8 more trials

Muscle Impact of Treating Osteoporosis

Active, not recruiting·NNami Safai Haeri·Phase 4·NCT05666310·20 enrolled

Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid

Completed· Novartis logo

Novartis·Phase 3·NCT00097812·220 enrolled

Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis

Completed· Amgen logo

Amgen·Phase 4·NCT01732770·643 enrolled

Zoledronic Acid in MS-patients With Osteoporosis

Terminated· Novartis logo

Novartis·Phase 3·NCT01166178·29 enrolled

Zoledronic Acid in Preventing Osteoporosis in Patients Undergoing Donor Stem Cell Transplant

Completed·UUniversity of Minnesota·Phase 2·NCT00321932·61 enrolled

Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis

Completed· Novartis logo

Novartis·Phase 3·NCT00439244·412 enrolled

3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs

Completed· Novartis logo

Novartis·Phase 3·NCT00718861·190 enrolled

Denosumab for the Treatment of Osteoporosis in Children: A Pilot Study

Completed·—·Phase 2·NCT02632916·10 enrolled

Bone Metastasis10 trials

Zometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis

Completed·FFudan University·Phase 2/3·NCT00524849·60 enrolled

Efficacy of Radiotherapy in Combination With Zoledronic Acid in Bone Metastasis Patients With Gastrointestinal Tumors

Completed·SSeverance Hospital·Phase 2·NCT02784652·60 enrolled

Using TRAP to Evaluate the Effect of Zometa on Bone Metastasis Due to Lung Cancer

Terminated·UUniversity of Louisville·Phase 2·NCT00265200·28 enrolled

Show 7 more trials

Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis

Completed· Novartis logo

Novartis·Phase 4·NCT00172003·50 enrolled

Preventive Effects of Zoledronic Acid on Bone Metastasis in Patients With Stage IIIB and IV Lung Cancer

Unknown status·TTang-Du Hospital·Phase 3·NCT02622607·200 enrolled

Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy

Completed· Novartis logo

Novartis·Phase 4·NCT00237146·38 enrolled

Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis

Completed· Novartis logo

Novartis·Phase 4·NCT00241111·148 enrolled

Effect of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastasis

Completed· Novartis logo

Novartis·Phase 4·NCT00237159·284 enrolled

Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis

Recruiting·WWashington University School of Medicine·Phase 1/2·NCT06374459·152 enrolled

Study Comparing Full-dose Radiotherapy Versus Reduced Dose in the Management of Bone Metastasis in Patients With Breast Cancer Receiving Zoledronic Acid

Completed· Novartis logo

Novartis·Phase 4·NCT00172029·116 enrolled

74 more indications

Non-Small Cell Lung Cancer6 trials

Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer

Completed· Amgen logo

Amgen·Phase 2·NCT01951586·226 enrolled

Non-small Cell Lung Cancer Study US75 (Z-PACT)

Completed· Novartis logo

Novartis·Phase 3·NCT00086268·250 enrolled

Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer

Terminated·—·Phase 2·NCT01004510·3 enrolled

Show 3 more trials

A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC)

Completed· Novartis logo

Novartis·Phase 3·NCT00172042·437 enrolled

Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer

Unknown status·—·Phase 4·NCT02480634·280 enrolled

Non-small Cell Lung Cancer Registry

Completed· Novartis logo

Novartis·Phase 4·NCT00099541·300 enrolled

Osteonecrosis5 trials

Mononuclear Cells, Platelets and Zoledronic Acid for Preventing Collapse of the Femoral Head in Osteonecrosis

Unknown status·—·N/A·NCT02721940·100 enrolled

Genetics in Predicting Risk of Bisphosphonate-Related Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid

Withdrawn·UUniversity of Southern California·N/A·NCT02069340

Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study

Withdrawn·—·Phase 2·NCT02632903

Show 2 more trials

Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee

Withdrawn· Novartis logo

Novartis·Phase 2·NCT00477217

Osteonecrosis of the Hip and Bisphosphonate Treatment

Unknown status·UUniversity of Sydney·Phase 2·NCT00781261·120 enrolled

Postmenopausal Women4 trials

Letrozole With or Without Zoledronate in Treating Healthy Postmenopausal Women With High Breast Density

Completed·UUniversity of Virginia·N/A·NCT00114270

Intervenous (IV) Zoledronic Acid After Forteo in Postmenopausal Women

Completed·TThe Cleveland Clinic·N/A·NCT00361595·35 enrolled

Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01F and T121E02F in Healthy Postmenopausal Women

Completed·TThar Pharmaceuticals, Inc·Phase 1·NCT01721993·71 enrolled

Show 1 more trial

Comparative Effect of Zoledronic Acid Versus Denosumab on Serum Sclerostin of Postmenopausal Women With Low Bone Mass

Completed·—·N/A·NCT01572545·91 enrolled

Metastatic Prostate Cancer4 trials

Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00869206·1,822 enrolled

Prevention of Micro-architectural Bone Decay in Males With Non-metastatic Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)

Completed·AAustin Health·Phase 2/3·NCT01006395·64 enrolled

A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates

Completed· Novartis logo

Novartis·Phase 4·NCT00172016·43 enrolled

Show 1 more trial

Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy

Active, not recruiting·MMedical Research Council·Phase 2/3·NCT00268476·11,992 enrolled

Spinal Cord Injury4 trials

Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density

Unknown status·SSheba Medical Center·Phase 4·NCT04597931·30 enrolled

FES-Rowing Versus Zoledronic Acid to Improve Bone Health in Spinal Cord Injury (SCI)

Terminated·AAntonio Lazzari·Phase 2/3·NCT01426555·70 enrolled

Zoledronic Acid in Acute Spinal Cord Injury

Completed·TThomas Jefferson University·Phase 3·NCT01642901·16 enrolled

Show 1 more trial

Zoledronic Acid Administration in Acute Spinal Cord Injury

Completed·JJames J. Peters Veterans Affairs Medical Center·Phase 4·NCT02042872·21 enrolled

Bariatric Surgery3 trials

Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery (ZABAS)

Unknown status·SStinus Gadegaard Hansen·Phase 2·NCT04742010·60 enrolled

Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery

Completed·MMassachusetts General Hospital·Phase 4·NCT03424239·6 enrolled

Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

Completed·MMassachusetts General Hospital·Phase 4·NCT04087096·36 enrolled

Paget's Disease of Bone3 trials

Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)

Completed· Novartis logo

Novartis·Phase 4·NCT00774020·9 enrolled

Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

Completed· Novartis logo

Novartis·Phase 3·NCT00051636·172 enrolled

Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

Completed· Novartis logo

Novartis·Phase 3·NCT00103740·185 enrolled

Osteogenesis Imperfecta3 trials

Diagnosis of Osteogenesis Imperfecta in Children

Unknown status·—··NCT03169192·40 enrolled

The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta

Terminated·UUniversity of Aarhus·Phase 2·NCT01679080·9 enrolled

Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid

Completed·UUniversity of Edinburgh·Phase 4·NCT03735537·350 enrolled

Osteosarcoma3 trials

Zoledronic Acid and Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Osteosarcoma

Completed·CChildren's Oncology Group·Phase 1·NCT00742924·24 enrolled

Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma

Unknown status·TTata Memorial Hospital·Phase 2/3·NCT00691236·60 enrolled

Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT03932071·150 enrolled

Bone Loss3 trials

Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation

Unknown status·UUniversity of Calgary··NCT05405894·20 enrolled

Bone Loss and Immune Reconstitution in HIV/AIDS (BLIR-HIV)

Completed·EEmory University·Phase 2·NCT01228318·63 enrolled

Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplants

Completed·UUniversity of Nebraska·N/A·NCT00580047·59 enrolled

Fracture2 trials

Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data

Completed·—··NCT04736693·18,028 enrolled

HORIZON-PFT: Pivotal Fracture Trial

Completed· Novartis logo

Novartis·Phase 3·NCT00049829·7,700 enrolled

Efficacy2 trials

Efficacy of Zoledronic Acid in Enhancement of Early Stability of Cementless Primary Hip Prosthesis

Completed·TTurku University Hospital·Phase 4·NCT01218035·49 enrolled

A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate

Completed· Novartis logo

Novartis·Phase 3·NCT00100555·120 enrolled

Low Bone Mineral Density2 trials

Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density

Completed· Novartis logo

Novartis·Phase 4·NCT00431444·110 enrolled

Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density

Completed· Amgen logo

Amgen·Phase 2·NCT00896532·419 enrolled

Postmenopausal Osteoporosis2 trials

A Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on Bone Mineral Density (BMD) in Postmenopausal Osteoporosis (PMO) Patients Between the Ages of 50 and 65 Years

Completed· Novartis logo

Novartis·Phase 3·NCT00909961·118 enrolled

µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis

Completed·UUniversity of Pennsylvania·Phase 4·NCT01153425·33 enrolled

Triple-Negative Breast Cancer2 trials

Zoledronic Acid as Adjuvant Treatment of Triple-negative Breast Cancer

Unknown status·CChinese Academy of Medical Sciences·Phase 3·NCT02595138·430 enrolled

Study on Bisphosphonates Targeting Triple-negative Breast Cancer

Unknown status·SShengjing Hospital··NCT04045522·120 enrolled

Osteopenia2 trials

Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older

Completed· Novartis logo

Novartis·Phase 3·NCT00132808·581 enrolled

Zoledronate for Osteopenia in Pediatric Crohn's

Completed·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 3·NCT00798473·13 enrolled

Prevention2 trials

Prevention of Bone Loss After Acute SCI by Zoledronic Acid

Completed·NNorthwestern University·Phase 2·NCT02325414·60 enrolled

A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss

Terminated· Novartis logo

Novartis·Phase 4·NCT00333229·11 enrolled

Neuroblastoma2 trials

Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma

Terminated·UUniversity of Alabama at Birmingham·Phase 1·NCT01404702·4 enrolled

N2007-02:Bevacizumab,Cyclophosphamide,& Zoledronic Acid in Patients W/ Recurrent or Refractory High-Risk Neuroblastoma

Completed·NNew Approaches to Neuroblastoma Therapy Consortium·Phase 1·NCT00885326·29 enrolled

Safety and Efficacy2 trials

Safety and Efficacy Study of Concomitant Radiotherapy and Zoledronic Acid for Bone Metastases Palliation

Completed·TThe Cleveland Clinic·Phase 1·NCT00264420·4 enrolled

1 Year Open-label Extension to CZOL446H2337 Safety and Efficacy Trial of Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids

Completed· Novartis logo

Novartis·Phase 3·NCT01197300·25 enrolled

Chemotherapy1 trial

Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00352846·135 enrolled

Thalassemia1 trial

Evaluation of Efficacy of Zoledronic Acid in Patients With Haemoglobin Syndromes (Thalassemia and Sicle Cell Anaemia) and Risk of Skeletal Events

Completed· Novartis logo

Novartis·Phase 4·NCT00346242·60 enrolled

Bone Resorption1 trial

Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy

Completed· Novartis logo

Novartis·Phase 3·NCT00172055·218 enrolled

Surgery1 trial

Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries

Completed·GGynecologic Oncology Group·Phase 2·NCT00305695·160 enrolled

Cervical Cancer1 trial

Study of Zoledronic Acid Versus Observation on Bone Mineral Density and Incidence of Micrometastasis in Women Undergoing Pelvic Radiation for Cervical Cancer

Terminated·WWashington University School of Medicine·Phase 2·NCT00966992·3 enrolled

Dexamethasone1 trial

Phase III Randomized Trial of Thalidomide/Dexamethasone Versus Vincristine+Adriamycin+Dexamethasone (VAD)

Terminated·HH. Lee Moffitt Cancer Center and Research Institute·Phase 3·NCT00215943·90 enrolled

Primary Hyperparathyroidism1 trial

Osteoporosis in Primary Hyperparathyroidism

Unknown status·UUniversity Medical Centre Ljubljana·Phase 4·NCT04085419·40 enrolled

Liver Transplant1 trial

The Effect of Zoledronic Acid on Bone Density in Liver Transplant Patients

Completed·—·Phase 4·NCT00114556·100 enrolled

Osteoarthritis1 trial

Effect of Zoledronic Acid in Primary Knee Osteoarthritis

Unknown status·TToufiqe-E-Ealahi·Phase 4·NCT06051344·92 enrolled

Chondrosarcoma1 trial

Anti-Osteoclast Therapy as Neoadjuvant in Treatment of Chondrosarcoma - Phase 1b Trial

Active, not recruiting·MMohammed Milhem·Phase 1·NCT03173976·17 enrolled

Pancreatic Cancer1 trial

Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer

Active, not recruiting·UUniversity of Nebraska·Phase 2·NCT03073785·46 enrolled

Musculoskeletal1 trial

Bisphosphonates for the Treatment of Seropositive Musculoskeletal Complaints

Unknown status·KKarolinska Institutet·Phase 4·NCT04115397·80 enrolled

Malignant Solid Tumors1 trial

A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid

Not yet recruiting·SShanghai JMT-Bio Inc.·Phase 3·NCT06221072·1,360 enrolled

Hip Fracture1 trial

Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture

Completed· Novartis logo

Novartis·Phase 3·NCT00046254·2,127 enrolled

Treatment1 trial

Re-treatment of Participants With Paget's Disease Using Zoledronic Acid

Completed· Novartis logo

Novartis·Phase 4·NCT00740129·6 enrolled

Long Term Efficacy and Safety1 trial

Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases

Completed· Novartis logo

Novartis·Phase 4·NCT00434447·73 enrolled

Myelofibrosis1 trial

A Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia (MMM)

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 2·NCT00287261·17 enrolled

Lumbar Degenerative Disease1 trial

The Effect of Zoledronic Acid to Bone Fusion and Bone Metabolism of Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion

Unknown status·FFudan University·Phase 4·NCT01310465·50 enrolled

Gastric Cancer1 trial

Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer

Completed· Astellas logo

Astellas·Phase 1·NCT01671774·29 enrolled

Bone1 trial

Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation

Completed·—·Phase 4·NCT02499237·57 enrolled

Bone Disease1 trial

A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain

Terminated· Roche logo

Roche·Phase 3·NCT00099177·96 enrolled

Femur Fracture1 trial

Trochanteric Femur Fracture Operated With Dynamic Hip Screw System (DHS) Augmented With a Biphasic Apatite Sulphate Combined With Systemic or Local Bisphosphonate

Unknown status·LLithuanian University of Health Sciences·N/A·NCT04498715·20 enrolled

Stroke1 trial

Effect of Zoledronic Acid on Prevention of Bone Loss in Acute Phase First-ever Stroke Patients

Unknown status·YYonsei University·N/A·NCT04652128·56 enrolled

Giant Cell Tumor1 trial

Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone

Recruiting·SSt. Louis University·Phase 3·NCT03295981·120 enrolled

Radiotherapy1 trial

RADAR Trial - Randomised Androgen Deprivation and Radiotherapy

Completed·TTrans Tasman Radiation Oncology Group·Phase 3·NCT00193856·1,071 enrolled

Menopausal Women1 trial

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 logo

Novartis·Phase 3·NCT00145275·455 enrolled

Sickle Cell Disease1 trial

Phase 1 Study of Zoledronic Acid in Sickle Cell Disease

Withdrawn·VVirginia Commonwealth University·Phase 1/2·NCT00639392

Ewing sarcoma1 trial

Study in Localized and Disseminated Ewing Sarcoma

Completed·UUniversity Hospital Muenster·Phase 3·NCT00987636·907 enrolled

Anemia1 trial

Zoledronic Acid Treatment in Patients With Congenital Dyserythropoietic Anemia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 1/2·NCT07471516·2 enrolled

Prostate CA1 trial

Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation

Terminated·NNorthwestern University·Phase 3·NCT00058188·53 enrolled

Adenocarcinoma1 trial

Estramustine, Docetaxel and Zoledronate Treatment in Hormone-Refractory Adenocarcinoma of the Prostate

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT00151073·28 enrolled

Idiopathic Inflammatory Myopathies1 trial

Treating Idiopathic Inflammatory Myopathies Related Reduced Bone Mineral Density With Denosumab or Zoledronic Acid

Unknown status·KKwong Wah Hospital·Phase 3·NCT04034199·40 enrolled

Amenorrhea1 trial

Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea

Recruiting·MMassachusetts General Hospital·Phase 3·NCT06533865·114 enrolled

Diabetes Mellitus1 trial

Zoledronic Acid or Methylprednisolone for Active Charcot's Neuroarthropathy of Foot in Patients With Diabetes Mellitus

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 2/3·NCT03289338·36 enrolled

Infusion1 trial

Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid

Completed· Novartis logo

Novartis·Phase 4·NCT00745485·186 enrolled

Physical Activity1 trial

Effects of Zometa and Physical Activity on Bone Density in Women Receiving Chemotherapy for Breast Cancer

Completed·HHealthPartners Institute·Phase 3·NCT00202059·72 enrolled

Metastatic1 trial

Duration of Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Men With Metastatic CRPC

Completed·UUniversity Health Network, Toronto··NCT01062503·48 enrolled

High Risk1 trial

Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT)

Terminated·LLeiden University Medical Center·Phase 2·NCT00889590·15 enrolled

Patients With Solid Tumors1 trial

Zoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone

Completed· Novartis logo

Novartis·Phase 3·NCT00003884·600 enrolled

Kidney Transplant1 trial

Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation

Completed·UUniversity of Sao Paulo General Hospital·Phase 4·NCT01675089·34 enrolled

Transplantation1 trial

Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation

Completed·—·Phase 2/3·NCT00297830·111 enrolled

Rheumatoid Arthritis1 trial

Zoledronic Acid in Rheumatoid Arthritis

Terminated·CCarmen Gómez-Vaquero·Phase 3·NCT02123264·28 enrolled

Double-blind1 trial

Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled (DBMZol)

Terminated·NNantes University Hospital·Phase 3·NCT01802658·12 enrolled

ILD1 trial

Romosozumab Use to Build Skeletal Integrity

Active, not recruiting·SSusan L. Greenspan·Phase 4·NCT05058976·184 enrolled

Hematopoietic Cell Transplant Recipient1 trial

Pilot Trial of Zoledronic Acid to Prevent Bone Loss in Hematopoietic Cell Transplant Recipients

Withdrawn·SStanford University·N/A·NCT02451462

Pancreas Cancer1 trial

Perioperative Treatment With Zoledronic Acid in Patients With Resectable Pancreas Cancer

Terminated·WWashington University School of Medicine·Phase 1·NCT00892242·24 enrolled

TIA1 trial

Denosumab Sequential Therapy

Completed·NNational Taiwan University Hospital·Phase 4·NCT03868033·101 enrolled

Fractures1 trial

FARE Augmentation of Proximal Femoral Fractures With CaS/HA and Systemic ZA

Completed·—·Phase 4·NCT06135298·20 enrolled

Relapsed or Refractory1 trial

A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients

Completed· Novartis logo

Novartis·Phase 1·NCT00741377·28 enrolled

Bone Marrow Transplantation1 trial

Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients

Unknown status·TTehran University of Medical Sciences·Phase 2/3·NCT01016093·50 enrolled

Kidney Cancer1 trial

Adoptive Immunotherapy, Aldesleukin, and Zoledronate in Treating Patients With Stage IV Kidney Cancer and Lung Metastases

Completed·—·Phase 1/2·NCT00588913·20 enrolled

Complex Regional Pain Syndrome1 trial

The Use of Zoledronic Acid to Complex Regional Pain Syndrome

Unknown status·UUniversity of Sao Paulo General Hospital·Phase 2·NCT01788176·40 enrolled

Intravenous1 trial

Intravenous Bisphosphonate in Stress Fracture Treatment -A Randomised Controlled Double Blinded Multicenter Trial

Terminated·OOslo University Hospital·Phase 4·NCT03576599·5 enrolled

Knee Injury1 trial

Altering Bone Microarchitecture and Mechanics by Off-label Pharmaceutical Intervention Following an Acute Knee Injury

Terminated·UUniversity of Calgary·Phase 1·NCT05204836·4 enrolled

Unspecified4 trials

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

Completed·AAustrian Breast & Colorectal Cancer Study Group·Phase 3·NCT00295646·1,803 enrolled

Denosumab and Teriparatide Study (DATA-HD and DATA-EX)

Completed·MMassachusetts General Hospital·Phase 4·NCT02176382·76 enrolled

Pharmacokinetic, Safety and Tolerability Study of SC Administered Bisphosphonate With rHuPH20 vs Bisphosphonate Alone

Completed·HHalozyme Therapeutics·Phase 1·NCT00807963·31 enrolled

Show 1 more trial

Intra-venous Zoledronic Acid Once Yearly

Completed· Novartis logo

Novartis··NCT00984893·1,551 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 20, 2001

ZOMETA

NDA NDA021223

Apr 16, 2007

RECLAST

NDA NDA021817

Aug 2, 2013

ZOLEDRONIC ACID

NDA NDA203231

Dec 28, 2015

ZOLEDRONIC ACID

NDA NDA204016

Sources

References

[1]
ClinicalTrials.gov — 262 trial records for Zoledronic acid. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zometa drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Zoledronic acid compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Zoledronic acid. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA204016). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Zometa. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Farnesyl Diphosphate Synthase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Patent Landscape[6]

Patent Cliff

Feb 5, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7932241Feb 5, 2028

7932241*PEDAug 5, 2028