A study to assess MK0822 in men with osteoporosis (053)

• Research type

  Research Study

• Full title

  A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) in the Treatment of Men with Osteoporosis Treated with Vitamin D and Calcium

• IRAS ID

  54296

• Contact name

  Paul Robinson

• Sponsor organisation

  Merck Sharp & Dohme Corp

• Eudract number

  2010-019454-41

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study will assess the efficacy and safety of a new medication for the treatment of male osteoporosis.Osteoporosis is characterised by a reduction in bone density which results in bone weakness and a substantially increased risk of bone fracture. Although not as common as female osteoporosis, it is thought that male osteoporosis affects approximately 3 million men in the EU. It has been estimated that 1 out of 5 men aged over 50 will experience a fracture, mainly due to poor bone health.By using medicines to increase bone density the risk of having a fracture can be reduced. MK0822 (odanacatib) is a novel potential treatment for osteoporosis and in an ongoing study in females it has been shown to increase bone density. We now want to assess odanacatib in the treatment of osteoporosis in males.At the beginning of the study, potential participants will be assessed to check if they have osteoporosis/low bone density. Suitable men who choose to take part will take study treatment for about 36 months and will attend the clinic on about 9 occasions. Participants will take either odanacatib or placebo (placebo is an inactive tablet that looks like odanacatib tablet) and we can then assess whether odanacatib increases bone density more than placebo. Bone density is assessed using a DXA scan which is an X-ray that's 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 Birmingham, Cardiff, Manchester and Liverpool; and also by a commercial company called Medinova in North London.The research is being funded by the pharmaceutical company that's developing the study drug.

• REC name

  London - South East Research Ethics Committee

• REC reference

  10/H1102/39

• Date of REC Opinion

  21 Sep 2010

• REC opinion

  Further Information Favourable Opinion