Conditions: Osteoporosis, Postmenopausal Back Pain Spinal Fracture
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 712
Healthy volunteers: no

Brief summary:
The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.

Detailed description:

Arms:
arm 1: Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo arm 2: Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Interventions: intervention 1: teriparatide intervention 2: risedronate intervention 3: placebo intervention 4: placebo
Intervention descriptions: intervention 1: 20 ug/day, subcutaneous, 18 months intervention 2: 35 mg/once weekly, oral, 18 months intervention 3: once weekly, oral, 18 months intervention 4: daily, subcutaneous, 18 months

Protocol document: