Open-Label Extension to the Odanacatib Fracture Trial (PN018)

• Research type

  Research Study

• Full title

  An Open-Label 5-Year 2nd Extension to: A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium

• IRAS ID

  164511

• Contact name

  Venkata Kondagunta

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

• Eudract number

  2014-002587-33

• Duration of Study in the UK

  5 years, 2 months, 27 days

• Research summary

  Osteoporosis is the most common type of metabolic bone disease which is characterised by a reduction in bone density as people age. Approximately 30% of all postmenopausal women in Europe have osteoporosis and as a consequence, at least 40% of these will sustain one or more fractures of the hip, vertebrae, wrist or ribs.

  This phase III extension study will continue to evaluate the long-term safety and effectiveness of the drug odanacatib (MK-0822, developed by Merck) in combination with vitamin D and calcium in reducing the risk of fracture in postmenopausal female patients with osteoporosis.

  A previous study with odanacatib in patients with osteoporosis showed that long-term treatment can result in increases in bone density and decreased bone resorption (the breaking down of bone). Odanacatib has a different action and simpler dosing schedule to the current standard of care treatment, in particular bisphosphonates, which have to be taken on an empty stomach and have associated toxicity.

  This study is an open-label extension study which will include postmenopausal female subjects previously treated with odanacatib once-weekly and subjects that previously received placebo in the base study and extension study. All subjects in this extension study will receive 50 milligrams of odanacatib (active study medication) once-weekly together with vitamin D and calcium.
  Subjects participating in this study will visit the clinic about 9 times and receive phone calls over the 5 year period. Subjects will be monitored for their osteoporosis and general health, asked to complete a diary card, questionnaire and provide blood and urine samples.
  About 5000 subjects will take part in this study.
  The study is funded by Merck Sharp & Dohme Limited.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  15/LO/0006

• Date of REC Opinion

  22 Jan 2015

• REC opinion

  Favourable Opinion