Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
Summary
Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.
Timeline
- Start
- 2002-11
- Primary completion
- 2006-07
- Completion
- 2008-01
Outcome
Met primary endpoint
paper increased more in the teriparatide group than in the alendronate group (7.2+/-0.7% vs. 3.4+/-0.7%, P<0.001). PMID 18003959 ↗
release “The mean increase in lumbar spine BMD with teriparatide was significantly greater compared with Fosamax after six months through 18 months of therapy” lilly.com ↗
release “in patients with glucocorticoid-induced osteoporosis FORTEO(R) (PTH 1-34, teriparatide [rDNA origin] injection) significantly increased lumbar spine bone mineral density” lilly.com ↗
Publications
- Saag KG, Agnusdei D, Hans D, Kohlmeier LA, Krohn KD, Leib ES, MacLaughlin EJ, Alam J, Simonelli C, Taylor KA, Marcus R. Trabecular Bone Score in Patients With Chronic Glucocorticoid Therapy-Induced Osteoporosis Treated With Alendronate or Teriparatide. Arthritis Rheumatol. 2016 Sep;68(9):2122-8. doi: 10.1002/art.39726.
- Devogelaer JP, Adler RA, Recknor C, See K, Warner MR, Wong M, Krohn K. Baseline glucocorticoid dose and bone mineral density response with teriparatide or alendronate therapy in patients with glucocorticoid-induced osteoporosis. J Rheumatol. 2010 Jan;37(1):141-8. doi: 10.3899/jrheum.090411. Epub 2009 Nov 16.
- Saag KG, Shane E, Boonen S, Marin F, Donley DW, Taylor KA, Dalsky GP, Marcus R. Teriparatide or alendronate in glucocorticoid-induced osteoporosis. N Engl J Med. 2007 Nov 15;357(20):2028-39. doi: 10.1056/NEJMoa071408.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alendronic Acid | Small molecule | 10 mg | Oral |
| Subject | Teriparatide | Protein / enzyme biologic | 20 ug | Subcutaneous |