Conditions: Osteoporosis
Keywords: Glucocorticoid Induced
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 92
Healthy volunteers: no

Brief 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.

Detailed description:
This study is a multinational, European, multicenter, randomized, open-label, active comparator controlled study with 2 study periods: a screening phase of up to 6 weeks, and an open-label treatment phase of 18 months. Approximately 100 adult men with osteoporosis associated with sustained glucocorticoid therapy will be enrolled into the study. Approximately one-half of the participants (at all investigational sites) will be randomized to teriparatide 20 micrograms/day (ug/day given as a subcutaneous (sc) injection), and the other half randomized to risedronate 35 milligrams (mg) once weekly (QW) oral (po) tablet. All participants will receive approximately 1000 mg/day elemental calcium and 800 to 1200 international units per day (IU/day) of vitamin D.

Arms:
arm 1: Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD). arm 2: Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)

Interventions: intervention 1: Teriparatide intervention 2: Risedronate
Intervention descriptions: intervention 1: 20 µg/day sc for 18 months intervention 2: 35 mg/week po for 18 months

Protocol document: