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Found 46 clinical trials
Denosumab Biosimilar Injection in Post Menopausal Women With Osteoporosis

Denosumab of Intas is biosimilar denosumab candidate under development by Intas Pharmaceutical Limited (Biopharma Division). Denosumab of Intas is already approved by Indian drug licensing

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bone mineral density
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  • 0 views
  • 05 Jul, 2022
  • 1 location
A Randomised, Double-blind, Parallel, Multicentre, Multinational Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 (Proposed Denosumab Biosimilar) Versus Prolia® (EU-sourced) in Postmenopausal Women With Osteoporosis (SIMBA Study)

This is a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with osteoporosis

  • 0 views
  • 15 Sep, 2022
  • 45 locations
Romosozumab/Denosumab Study for Premenopausal IOP

210 mg monthly followed by 12M of denosumab 60 mg SC q6M. Aim 1 will define the within-group effects of this regimen. Aim 2 will compare results from participants treated with romosozumab-denosumab to

  • 28 views
  • 04 Apr, 2021
  • 2 locations
Desomumab vs Zoledronic Acid and Osteoporotic Compression Fracture

Bone mineral density and function at 1 year after screw fixation with desomumab vs zoldronic acid for osteoporotic vertebral compression fractures: a parallel double-blind randomized controlled clinical trial

Accepts healthy volunteers
  • 0 views
  • 11 Nov, 2021
  • 1 location
Denosumab and Screw Fixation for Osteoporotic Compression Fracture

Evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: a parallel double-blind randomized controlled clinical trial

Accepts healthy volunteers
  • 0 views
  • 09 Oct, 2021
  • 1 location
Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers

This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male volunteers.

Accepts healthy volunteers
  • 0 views
  • 14 Apr, 2022
Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Male Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS (DENARIUS)

This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy adult male volunteers.

Accepts healthy volunteers
  • 0 views
  • 30 Apr, 2022
  • 1 location
FITMI - First In Treating Male Infertility

This RCT aims to assess whether treatment with Denosumab can improve semen quality in infertile men selected by serum AMH as a positive predictive biomarker.

  • 0 views
  • 21 Mar, 2022
  • 1 location
Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life (PRISM)

To evaluate the current medical practice and its influence on health-related quality of life, in patients who are treated with injectable bone antiresorptive drugs (biphosphonates or denosumab

  • 20 views
  • 27 May, 2022
  • 2 locations
A Randomized, Double-Blind, International Multicentre, Parallel-Controlled Phase III Clinical Study to Evaluate Recombinant Anti-RANKL Human Monoclonal Antibody Injection (HLX14) Versus Denosumab Injection (Prolia®) in Postmenopausal Women With Osteoporosis at High Risk of Fracture

This is a randomized, double-blind, international multicentre, parallel-controlled phase III clinical study. The study plans to enroll 430 postmenopausal women with osteoporosis at high risk of fracture, whom will be randomized at 1:1 to either the experiment group (HLX14) or the control group (Prolia®) based on stratification factors (BMI (< …

  • 0 views
  • 23 Sep, 2022
  • 31 locations