VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)

Lilly

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Vitamin D; Drug: Risedronate; Drug: Calcium; Drug: Placebo; Drug: Teriparatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01709110

B3D-EW-GHDW (Other Identifier)

14536

2012-000123-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,366 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women with osteoporosis, as defined by low bone mineral density (BMD), i.e. anterior-posterior lumbar spine, total hip or femoral neck BMD ≥1.5 standard deviations below the average BMD for young, healthy, non-Hispanic, Caucasian women
• A minimum of 2 moderate or 1 severe vertebral fragility fractures (confirmed by central reader) were required

Exclusion criteria

• Increased risk of osteosarcoma
• History of unresolved skeletal diseases that affect bone metabolism
• History of atypical subtrochanteric or diaphyseal femoral fractures
• Abnormally high or low calcium levels
• Abnormally high parathyroid hormone (PTH) levels
• Severe vitamin D deficiency
• Abnormal thyroid function not corrected by therapy
• History of malignant neoplasms in the last 5 years
• Active liver disease, clinical jaundice
• Significant impairment of hepatic or renal function
• History of nephro- or urolithiasis
• Previous or planned kypho- or vertebroplasty
• Active or risk for osteonecrosis of the jaw
• Active or recent history of upper gastrointestinal disorders
• Unable to stand or sit in the upright position for at least 30 minutes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,366 participants in 2 patient groups

Teriparatide

Experimental group

Description:

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.

Treatment:

Drug: Calcium

Drug: Placebo

Drug: Teriparatide

Drug: Vitamin D

Risedronate

Active Comparator group

Description:

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.

Treatment:

Drug: Calcium

Drug: Placebo

Drug: Vitamin D

Drug: Risedronate