drugset / Trial / NCT00503399
Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective of this study is to test the hypothesis that teriparatide is superior to the active comparator in the change from baseline to 18 months of lumbar spine volumetric trabecular bone mineral density (BMD) in males with glucocorticoid-induced osteoporosis.
Timeline
- Start
- 2007-07
- Primary completion
- 2010-10
- Completion
- 2010-10
Publications
- Gluer CC, Marin F, Ringe JD, Hawkins F, Moricke R, Papaioannu N, Farahmand P, Minisola S, Martinez G, Nolla JM, Niedhart C, Guanabens N, Nuti R, Martin-Mola E, Thomasius F, Kapetanos G, Pena J, Graeff C, Petto H, Sanz B, Reisinger A, Zysset PK. Comparative effects of teriparatide and risedronate in glucocorticoid-induced osteoporosis in men: 18-month results of the EuroGIOPs trial. J Bone Miner Res. 2013 Jun;28(6):1355-68. doi: 10.1002/jbmr.1870.
- Graeff C, Marin F, Petto H, Kayser O, Reisinger A, Pena J, Zysset P, Gluer CC. High resolution quantitative computed tomography-based assessment of trabecular microstructure and strength estimates by finite-element analysis of the spine, but not DXA, reflects vertebral fracture status in men with glucocorticoid-induced osteoporosis. Bone. 2013 Feb;52(2):568-77. doi: 10.1016/j.bone.2012.10.036. Epub 2012 Nov 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Risedronate | Small molecule | 35 mg | Oral |
| Subject | Teriparatide | Protein / enzyme biologic | 20 ug | Subcutaneous |