MedTrace Logo

Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

NCT00051558 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2009-03-12

Study results available
· View outcomes & findings →

Summary

Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.

Conditions

Interventions

DRUG

Teriparatide

20 micrograms/day, injection, 36 months

DRUG

Alendronate Sodium

10 mg/day, oral, 36 months

DRUG

Placebo

Oral placebo, daily, 36 months

DRUG

Placebo

Injection placebo, daily, 36 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
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2006-07-31
Completion
2008-01-31

Countries

  • United States
  • Austria
  • Belgium
  • Denmark
  • Norway
  • Puerto Rico

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 NCT00051558 on ClinicalTrials.gov