AMG 785/Alendronate in Postmenopausal women with Osteoporosis

• Research type

  Research Study

• Full title

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

• IRAS ID

  99815

• Contact name

  Stuart Ralston

• Sponsor organisation

  Amgen Ltd

• Eudract number

  2011-003142-41

• Research summary

  The purpose of this study is to find out more about AMG 785 in women with postmenopausal osteoporosis. The study is designed to evaluate if AMG 785 treatment for 12 months followed by alendronate treatment, compared with alendronate treatment alone, is effective in reducing the incidence of bone fractures in women with postmenopausal osteoporosis. Alendronate (also known as Fosamax©) 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 randomized into two groups. One group will receive AMG 785 and one will receive alendronate. Patients will have an equal chance of being assigned to the AMG 785 or alendronate group. Neither patient nor study doctor will know which treatment group the patient is in for the first year of the study. For the remainder of the study, all patients will receive alendronate and the patient and study doctor will know what they are receiving. The study will end when enough clinical fracture events have occurred (confirmed for at least 330 subjects) to be able to perform a statistical analysis of the study data. The end of the study for an indivudual patient will be no earlier than 24 months from their individual start date and is expected to be between 25 and 37 months.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  12/NW/0237

• Date of REC Opinion

  11 May 2012

• REC opinion

  Further Information Favourable Opinion