A study of MK5442 in the treatment of osteoporosis (012)

• Research type

  Research Study

• Full title

  A Phase IIb, Randomised, Double-Blind, Placebo-and Active-Controlled, Dose-Range-Finding Study to Evaluate the Effects of MK5442 on Bone Mineral Density (BMD) in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated with an Oral Bisphosphonate

• IRAS ID

  32911

• Contact name

  Paul Robinson

• Sponsor organisation

  Merck Sharp & Dohme Ltd

• Eudract number

  2009-014729-18

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study will evaluate MK5442 in the treatment of post menopausal osteoporosis in women who have previously been treated with bisphosphonate medicines.Osteoporosis is characterised by a reduction in bone density as people age. This results in bone weakness and a substantially increased risk of fracture. By using medicines such as bisphosphonates to increase bone density the risk of having a fracture can be reduced. Bisphosphonates do not always increase bone density sufficiently even after several years of treatment, so that in some women their risk of having a fracture is not significantly reduced.MK5442 is a new potential tablet treatment for osteoporosis that may increase bone density in those women who have already received bisphosphonates, but whose bone density has not increased sufficiently.At the beginning of the study patients will be assessed to check if they still have osteoporosis (low bone density) despite previous bisphosphonate treatment. Suitable patients will be in this study for about 24 months and will attend the clinic on about 9-13 occasions. Patients will take either MK5442, a bisphosphonate called alendronate or placebo (inactive tablet) and we can then assess whether MK5442 increases bone density more than alendronate and 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 place at research units owned by a commercial company called Synexus in Birmingham, Manchester, Liverpool, Chorley (Lancs) and Glasgow.The research is being funded by the pharmaceutical company that's developing the study medication.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/117

• Date of REC Opinion

  9 Dec 2009

• REC opinion

  Further Information Favourable Opinion