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Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis

NCT00343252 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 712

Last updated 2011-05-26

Study results available
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Summary

The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.

Conditions

  • Osteoporosis, Postmenopausal
  • Back Pain
  • Spinal Fracture

Interventions

DRUG

teriparatide

20 ug/day, subcutaneous, 18 months

DRUG

risedronate

35 mg/once weekly, oral, 18 months

DRUG

placebo

once weekly, oral, 18 months

DRUG

placebo

daily, subcutaneous, 18 months

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
2006-06-30
Primary Completion
2009-06-30
Completion
2010-06-30

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Italy
  • Mexico
  • Puerto Rico
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00343252 on ClinicalTrials.gov