2-Year Therapy With Teriparatide vs 1-yr Therapy Followed by 1-Year of Raloxifene or Calcium/Vit D in Severe Postmenopausal Osteoporosis

Summary

The primary purpose of the study is to compare 3 different osteoporosis therapies following one year of teriparatide.In the first year,all eligible patients received open-label teriparatide 20 micrograms/day.After 1 year, patients are randomly assigned to one of 3 possible follow-up treatment regimens for the second 12 months: continuation of teriparatide, switch to raloxifene, or no pharmacological treatment(other than the calcium and vitamin D supplements that everyone receives). Patients are stratified into 3 subsets: (a) patients who have never received any anti-osteoporosis treatment before; (b) patients who received prior antiresorptive treatment successfully; (c) patients who failed to respond adequately to prior antiresorptive drugs (such as bisphosphonates or raloxifene) in the past. These latter patients are not randomized at month 12 but will continue treatment with teriparatide 20 micrograms/day throughout the second year.

Timeline

Start

2002-08

Primary completion

—

Completion

2005-11

Publications

• Minne H, Audran M, Simoes ME, Obermayer-Pietsch B, Sigurethsson G, Marin F, Dalsky GP, Nickelsen T; EUROFORS Study Group. Bone density after teriparatide in patients with or without prior antiresorptive treatment: one-year results from the EUROFORS study. Curr Med Res Opin. 2008 Nov;24(11):3117-28. doi: 10.1185/03007990802466595. Epub 2008 Oct 6.

Drugs

Indications