Recent and Ongoing Research Projects by CCA Members

 

Member companies within IOF’s Committee of Corporate Advisors (CCA) are actively involved in the research and development of innovative new therapies and tools in the bone field.

Below IOF CCA members have provided key information about several of their recent or ongoing clinical trials and related publications. Please note: IOF has no involvement in any of the research projects described, nor does this listing imply endorsement. 

For further information, please contact the company directly.

Study of AGN1 LOEP to Prevent Secondary Hip Fractures (RESTORE)

 
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  • Summary: The RESTORE study is an interventional and randomized controlled trial. The study is designed to demonstrate that the treatment ANG1 Local Osteo-Enhancement Procedure (LOEP) can reduce the incidence of secondary hip fractures in osteoporotic women undergoing hip fracture repair surgery. ANG1 is a resorbable triphasic osteoconductive implant material. Prior pre-clinical and clinical studies have shown that the treatment with ANG1 LOEP increases the strength of treated proximal femurs. In RESTORE study, subjects from different countries are randomized into the treatment and control arms and receive the intervention immediately following hip fracture repair.
  • Endpoints:
    • Primary:
      • The cumulative incidence of secondary fragility hip fractures
      • The cumulative incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
    • Secondary:
      • Areal bone mineral density (aBMD) at the hip
      • Trabecular Bone Score (TBS)
  • Estimated enrolment: 2400 postmenopausal osteoporotic women presenting with an index hip fracture who will undergo surgical repair of the fractured hip
  • Age: 65 years and over
  • Estimated duration: April 2021 (start of the study) to April 2029 (completion of the study)
  • Principal investigator: AgNovos Healthcare USA, LLC
  • Country: Austria, Germany, Japan, Netherlands, Spain

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