VERtebral Fracture Treatment Comparisons in Osteoporotic Women

NCT01709110 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1366

Last updated 2019-09-23

Study results available
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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.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Teriparatide

Administered SC

DRUG

Risedronate

Administered orally

DRUG

Placebo

Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC.

DRUG

Calcium

Administered orally

DRUG

Vitamin D

Administered orally

Sponsors & Collaborators

Principal Investigators

  • 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) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Poland
  • Puerto Rico
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01709110 on ClinicalTrials.gov