VERtebral Fracture Treatment Comparisons in Osteoporotic Women

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Calcium; Calcium, Dietary; Ergocalciferols; Etidronic Acid; Risedronate Sodium; Risedronic Acid; Teriparatide; Vitamin D; Vitamins

Criteria

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