VERtebral Fracture Treatment Comparisons in Osteoporotic Women

Condition(s) targeted: Postmenopausal Osteoporosis

Intervention: Teriparatide (Drug); Risedronate (Drug); Placebo (Drug); Calcium (Drug); Vitamin D (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

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.

Official title: Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Proportion of Participants with New Vertebral Fractures

Secondary outcome:

Proportion of Participants with Pooled New and Worsening Vertebral Fractures

Proportion of Participants with Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures

Proportion of Participants with Non-Vertebral Fragility Fractures

Proportion of Participants with Major Non-Vertebral Fragility Fractures

Proportion of Participants with New Moderate and/or Severe Vertebral Fractures

Proportion of Participants with New Multiple (2 or more) Vertebral Fractures

Proportion of Participants with Pooled Fragility and Traumatic Non-Vertebral Fractures

Change from Baseline to 24 Months Endpoint in Height

Change from Baseline to 24 Month Endpoint in Back Pain using an 11-point Numerical Pain Rating Scale

Change from Baseline to 24 Month Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L]

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Female.

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) are 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

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Wyomissing, Pennsylvania 19610, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Montreal, Quebec H3T 1E2, Canada

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sainte-Foy, Quebec G1V 3M7, Canada

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Trois-Rivieres, Quebec G8Z 1Y2, Canada

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Saskatoon, Saskatchewan S7K 0H6, Canada

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Dallas, Texas 75231, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Seattle, Washington 98122, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Spokane, Washington 99204, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Madison, Wisconsin 53705, United States

Starting date: October 2012
Last updated: August 17, 2015