AMG 785/Placebo in Postmenopausal Women with Osteoporosis- 20070337

• Research type

  Research Study

• Full title

  A Multicenter, International, Randomized, Double-blind, Placebo controlled, Parallel-group Study to Assess the Efficacy and Safety of AMG 785 Treatment in Postmenopausal Women With Osteoporosis

• IRAS ID

  96738

• Contact name

  Hiremagalur Balaji

• Sponsor organisation

  Amgen Ltd

• Eudract number

  2011-001456-11

• ISRCTN Number

  ISRCTN

• Research summary

  The purpose of this study is to find out more about AMG 785 in women with postmenopausal osteoporosis. This study will see if AMG 785 prevents fractures of the bone and whether it causes any side effects. To do this, AMG 785 will be compared with a placebo over the course of one year. The placebo will look like AMG 785 but it will not contain active ingredients. Taking placebo is the same as not taking anything for osteoporosis. After one year, AMG 785 or placebo will be discontinued and all study participants will take denosumab for the following year. Denosumab (also known as Prolia©) is a medication to treat postmenopausal osteoporosis that has been approved by many regulatory health agencies worldwide (for example by the FDA and the EMA). For the first year, patients will be randomised into two groups. One group will receive the dummy drug treatment (placebo) with no active ingredients, and one will receive the active drug (AMG 785). Patients will have an equal chance of being assigned to the placebo group or AMG 785 group. Neither patient nor study doctor will know which treatment group the patient is in for the first year of the study. For the second year of the study, all patients will receive denosumab and the patient and study doctor will know what they are receiving.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/0440

• Date of REC Opinion

  9 May 2012

• REC opinion

  Further Information Favourable Opinion