Open-label Denosumab vs Actonel Post Menopausal Osteoporosis 20080099

• Research type

  Research Study

• Full title

  A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Monthly Actonel Therapies in Postmenopausal Women Transitioned from Weekly or Daily Alendronate Therapy.

• IRAS ID

  24424

• Contact name

  Naren Savani

• Sponsor organisation

  Amgen Inc

• Eudract number

  2009-010587-42

• ISRCTN Number

  N/A

• Research summary

  The purpose of this study is to compare the effectiveness of a medication called denosumab with the effectiveness of a medication called Actonel, for the treatment of postmenopausal (after menopause) osteoporosis, in women who are currently taking or recently stopped taking a medication called alendronate sodium.Osteoporosis is a disease of the bone that is characterised by a condition called low bone mineral density. People with this condition have an increased risk of breaking their bones, usually hip or back bones.Denosumab is the investigational product, which will be given by injection under the skin. It has been shown in previous animal and human studies to prevent the break down of bone that leads to low bone mineral density. Actonel is an approved tablet that has shown to reduce or prevent hip or spine fracture.The total duration of this study will be up to 13 months, including a 1-month eligibility period in the beginning. During the treatment period, subjects will have to visit the hospital or clinic three times, twice to receive the injection of denosumab or receive the package of Actonel. There will also be various blood tests done, hip and spine scans, physical examinations, vital signs taken, adverse event collection and questionnaires given. Each visit will take approximately 2-3 hours.Approximately 250 subjects enrolled will be asked to take part in a sub study, which will involve having additional blood drawn to further understand how the drugs are working. Subjects will be required to attend an additional study visit and also fast (no food or drink) for 10 hours prior to blood tests.Out of 800 subjects worldwide, 400 will receive denosumab by injection under the skin and 400 will receive Actonel as an oral tablet. A computer program will randomly decide which medication each subject will receive.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/38

• Date of REC Opinion

  17 Sep 2009

• REC opinion

  Further Information Favourable Opinion