Novartis: Osteoporosis trials

The registry lists 30 Osteoporosis studies with Novartis as lead sponsor. 0 are open to participants now and 12 have results posted.

Phase 1 5Phase 2 2Phase 3 18Phase 4 4No phase 1(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• 1 Year Open-label Extension to CZOL446H2337 Safety and Efficacy Trial of Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With GlucocorticoidsCompletedNCT01197300Phase 3Results posted
• Zoledronic Acid in MS-patients With OsteoporosisTerminatedNCT01166178Phase 3Results posted
• An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With GlucocorticoidsCompletedNCT00799266Phase 3Results posted
• 3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 YrsCompletedNCT00718861Phase 3Results posted
• Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone MassCompletedNCT00489424Phase 4Results posted
• Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With OsteoporosisCompletedNCT00439647Phase 3Results posted
• Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With OsteoporosisCompletedNCT00439244Phase 3Results posted
• Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral DensityCompletedNCT00431444Phase 4Results posted
• Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With OsteoporosisCompletedNCT00404820Phase 3Results posted
• Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast CancerCompletedNCT00332709Phase 3Results posted
• Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)CompletedNCT00145327Phase 3Results posted
• 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 TherapyCompletedNCT00050011Phase 3Results posted
• Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal WomenCompletedNCT01224717Phase 1
• Intra-venous Zoledronic Acid Once YearlyCompletedNCT00984893
• 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 YearsCompletedNCT00909961Phase 3
• Feasibility of Doctors' Rooms-based Infusion of Zoledronic AcidCompletedNCT00745485Phase 4
• Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal SubjectsCompletedNCT00676312Phase 1
• Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of Single and Multiple-Doses of ATF936 and AXT914 Administered Orally in Healthy Subjects.CompletedNCT00417261Phase 1
• Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal WomenCompletedNCT00411125Phase 1
• Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal WomenCompletedNCT00395395Phase 1
• 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 TherapyCompletedNCT00172055Phase 3
• Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis.CompletedNCT00170911Phase 2
• Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced OsteoporosisCompletedNCT00100620Phase 3
• Safety and Efficacy of AAE581 in Postmenopausal Women With OsteoporosisCompletedNCT00100607Phase 2
• A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral BisphosphonateCompletedNCT00100555Phase 3
• Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in MenCompletedNCT00097825Phase 3
• Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic AcidCompletedNCT00097812Phase 3
• The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation TherapyCompletedNCT00063609Phase 4
• HORIZON-PFT: Pivotal Fracture TrialCompletedNCT00049829Phase 3
• Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip FractureCompletedNCT00046254Phase 3