A Study of MK5442 in the Treatment of Osteoporosis

• Research type

  Research Study

• Full title

  A Phase IIb, Randomised, Placebo-Controlled, Dose-Ranging Study of MK5442 in the Treatment of Postmenopausal Women with Low-Normal Bone Mineral Density (BMD) or Osteoporosis

• IRAS ID

  19397

• Contact name

  Paul Robinson

• Sponsor organisation

  Merck & Co., Inc.

• Eudract number

  2009-012926-35

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  A study to evaluate MK5442 in the treatment of post menopausal osteoporosis: Osteoporosis is characterised by a reduction in bone density as people age. This results in bone weakness and a substantially increased risk of fracture. 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 bones such as hip and wrist. By using medicines to increase bone density the risk of having a fracture can be reduced. These medicines to treat osteoporosis are given as tablets or by injection. MK5442 is a novel potential tablet treatment for osteoporosis that may increase bone density more than other tablets that are currently used to treat osteoporosis. In previous small studies MK5442 has been shown to increase bone density, but we need to perform studies in more people who have osteoporosis to confirm this. At the beginning of the study patients will be assessed to check if they have osteoporosis. Suitable patients will be in this study for about 24 months and will attend the clinic on about 12 occasions. Patients will take either MK5442 or placebo (inactive tablet that looks like MK5442 tablet) and we can then assess whether MK5442 increases bone density more than placebo. Bone density is assessed using a DXA scan which is an X-ray that is used routinely in the NHS to diagnose osteoporosis. The study is expected to take pace at research units owned by a commercial company called Synexus in Reading, Birmingham, Cardiff, Manchester, Liverpool, Chorley (Lancs) and Glasgow; and also by a company called Medinova in North London. The research is being funded by the pharmaceutical company that is developing the study drug

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  09/H0802/92

• Date of REC Opinion

  25 Aug 2009

• REC opinion

  Further Information Favourable Opinion