Fracture healing with teriparatide versus risedronate
Research type
Research Study
Full title
Comparison of the Effects of Teriparatide with those of Risedronate on Lumbar Spine Bone Mineral Density in Men and Postmenopausal Women with Low Bone Mass and a Recent Pertrochanteric Hip Fracture
IRAS ID
6900
Sponsor organisation
Eli Lilly
Eudract number
2008-002693-35
Clinicaltrials.gov Identifier
Research summary
Osteoporosis is a bone diseasewhich causes bones to become brittle and fragile, making them prone to breakageand fractures. During our lifetime old bone is constantly replaced by new bone.After the age of about 30-35 years, our bones begin to lose density because oldbone is being lost faster than new bone can replace it. Teriparatide lowers thechances of breaking a bone if you are a woman with osteoporosis and have been throughthe menopause. It can also be used to treat men with weak bones. Teriparatideis designed to make bones stronger by helping new bone to grow. It differs frombisphosphonates, such as risedronate, which are designed to make bones strongerby slowing down the process that makes them weak. Patients will be randomlyassigned to two different treatment groups (A and B). There is an equal chanceof being randomised to each treatment. For the first six months treatment Arm Awill receive teriparatide once daily plus placebo oral tablet once weekly.After the initial 6 month period, patients will continue for a further 12months with teriparatide only. For the first six months treatment Arm B willreceive placebo subcutaneous injection once daily plus risedronate once weekly.After the initial 6 month period patients will continue for a further 12 monthswith risedronate only. The primary objective of the study is to compare theeffect of teriparatide against risedronate on the strength of the bone after ahip fracture. There will be 220 patients randomised to the study. Eli Lilly andCompany will be funding this study and will be recruiting across Europe and Latin America.
REC name
London - City & East Research Ethics Committee
REC reference
08/H0703/113
Date of REC Opinion
5 Nov 2008
REC opinion
Further Information Favourable Opinion