Parallel Study Comparing Administration of Romosozumab in Osteoporosis
Research type
Research Study
Full title
A Randomized, Multicenter, Open-label, Parallel Group Study in Postmenopausal Women With Osteoporosis to Evaluate the Noninferiority of Subject-administered Romosozumab via Autoinjector/Pen vs Healthcare Provider-administered Romosozumab via Prefilled Syringe
IRAS ID
234811
Contact name
Stuart Ralston
Contact email
Eudract number
2017-003512-40
Duration of Study in the UK
1 years, 5 months, 11 days
Research summary
This study is funded by Amgen and UCB to find out if postmenopausal women with osteoporosis can successfully self-inject product once a month with 2 auto-injector pens. BMD (bone mineral density) will be measured with a bone image called DXA, to find out the change from the baseline 1st dosing visit to the month 6 end of dosing visit. A comparison in this BMD measurement will be made with subjects who receive product administered by the site staff with 2 pre-filled syringes.
The study will take place in approximately 30 sites with 260 subjects from US, UK and Poland. The auto-injector pen is being developed so that subjects can use it at home, therefore they would not have visited the site as often. The needle is also hidden to help patients with a fear or dislike of needles, and may also reduce accidental needle stick injuries.
Patients can take part in the trial if they are postmenopausal aged between 55 and 90 years of age. Their BMD T-score measured by DXA in their spine or hip areas needs to be <= - 2.50. They will have had fracture in the past or have additional risk factors such as being >70 years old, a BMD T-score <=3, having a history of smoking, drinking alcohol or being underweight.
The study has up to 35 days of screening, followed by an open-label 6 months of active treatment and then 3 months of safety follow-up. It is approximately 10 months long. During the treatment phase, patients will have monthly visits, and then a visit 3 months later for a safety check.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
18/NE/0032
Date of REC Opinion
5 Mar 2018
REC opinion
Further Information Favourable Opinion