Conditions: Postmenopausal Osteoporosis
Keywords: Bone Loss Vertebral fractures
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1366
Healthy volunteers: no

Brief summary:
The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.

Detailed description:

Arms:
arm 1: Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months.

Placebo given orally once weekly for 24 months.

Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment. arm 2: Risedronate 35 milligram (mg) administered orally once weekly for 24 months.

Placebo given by SC injection once daily for 24 months.

Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment.

Interventions: intervention 1: Teriparatide intervention 2: Risedronate intervention 3: Placebo intervention 4: Calcium intervention 5: Vitamin D
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered orally intervention 3: Teriparatide arm placebo administered orally.

Risedronate arm placebo administered SC. intervention 4: Administered orally intervention 5: Administered orally

Protocol document: