A Study to Evaluate AMG 785 in Postmenopausal Women with Osteoporosis
Research type
Research Study
Full title
An Open-label, Randomized, Teriparatide-controlled Study to Evaluate the Effect of Treatment with AMG 785 in Postmenopausal Women with Osteoporosis Previously Treated with Bisphosphonate Therapy
IRAS ID
125340
Contact name
John Robinson
Contact email
Sponsor organisation
Amgen, Inc.
Eudract number
2012-002948-24
Research summary
The purpose of this study is to find out more about AMG 785 in women with postmenopausal osteoporosis who have a high risk of fracture and have previously received bisphosphonate therapy for osteoporosis.
This study will see if AMG 785 increases bone mineral density and whether it causes any side effects.
To do this, AMG 785 will be compared to teriparatide, which is a medication approved in many countries to treat postmenopausal osteoporosis.
Prior to entering the study subjects must have taken oral bisphosphonate treatment for their postmenopausal osteoporosis for a minimum of 3 years, with the last year treated with alendronate (a type of bisphosphonate)
Subjects will be randomised into two groups: one group will receive the AMG 785 and the other group will receive teriparatide treatment. Subjects will have an equal
chance of being assigned to the teriparatide group or AMG 785 group. Subjects and the study doctor will know which treatment group the subject has been assigned.
Subjects will be treated in the study for 12 months.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0334
Date of REC Opinion
26 Jun 2013
REC opinion
Further Information Favourable Opinion