REN001-201-DXA, a sub-study of the STRIDE study

• Research type

  Research Study

• Full title

  AN EXPLORATORY STUDY TO ASSESS CHANGE IN BONE MINERAL DENSITY (BMD) AFTER 24 WEEKS TREATMENT OF REN001 IN SUBJECTS TAKING PART IN THE STRIDE STUDY, USING DUAL-ENERGY X-RAY ABSORPTIOMETRY (DXA)

• IRAS ID

  299312

• Contact name

  Lynn Purkins

• Contact email

  lpurkins@reneopharma.com

• Sponsor organisation

  Reneo Pharma Ltd

• Duration of Study in the UK

  1 years, 2 months, 14 days

• Research summary

  This study is being carried out to assess bone mineral density (BMD) using dual-energy X-ray absorptiometry (DXA) evaluation in patients that are taking part in the REN001-201 ’STRIDE’ study. \n\nThe REN001-201 ‘STRIDE’ study is a global, multicenter “Double-blind, placebo-controlled, study to evaluate the efficacy and safety of 24 Weeks treatment with REN001 in patients with Primary Mitochondrial Myopathy” (STRIDE study). \n \nThe REN001-201-DXA sub-study will supplement the collection of biochemical markers of bone turnover and metabolism in the parent STRIDE study (REN001-201) to support the evaluation of REN001 on bone health. This study is being carried out in response to a request from the FDA (Food and Drug Administration) for more information on the effects of REN001 on bone health.

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  21/NS/0101

• Date of REC Opinion

  27 Aug 2021

• REC opinion

  Favourable Opinion