ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Comparison of Teriparatide With Alendronate on How it Effects Glucocorticoid-Induced Osteoporosis

This study has been completed.

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00051558
  Purpose

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 (a type of cortisone 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 will be comparing the effects of the study drug to an available drug called alendronate on glucocorticoid-induced osteoporosis.


Condition Intervention Phase
Osteoporosis
Drug: Teriparatide
Drug: Alendronate Sodium
Phase III

MedlinePlus related topics:   Fractures    Osteoporosis   

ChemIDplus related topics:   Alendronate    Alendronate sodium    Teriparatide    Teriparatide acetate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Whether the increase from baseline to 18 months in lumbar spine BMD induced by teriparatide statistically significantly exceeds that obtained with alendronate in women and men taking GC for a minimum of 3 months

Secondary Outcome Measures:
  • Whether the increase from baseline to 18 months in lumbar spine BMD induced by teriparatide statistically significantly exceeds that obtained with alendronate in women taking GC for a minimum of 3 months
  • The time course of BMD response at the lumbar spine from baseline until 18 months in women and men combined, and in women separately
  • To assess the effects on: the change from baseline in femoral neck and total hip BMD at 18 months,24 months,and 36 months,and in lumbar spine BMD at 24 and 36 months
  • The time course of BMD response at the femoral neck and total hip from baseline until 18 months
  • The time course of BMD response at the lumbar spine, femoral neck, and total hip from baseline until 36 months
  • The time course of response of biochemical markers of bone turnover from baseline until 18 months in subjects from a subset of the study centers
  • The time course of response of biochemical markers of bone turnover from baseline until 36 months in subjects
  • Any fracture, nonvertebral fractures, vertebral fractures, clinical vertebral fractures, and severity fractures at 36 months
  • Adverse experience, laboratory variables, and other aspects of subject safety and tolerance of the study drugs

Estimated Enrollment:   450
Study Start Date:   November 2002
Study Completion Date:   January 2008
Primary Completion Date:   January 2008 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Men or women age 21 years or older
  • Taking on average 5.0 mg/day prednisone or equivalent

Exclusion Criteria:

  • Taking bisphosphonates within past 6 months
  • More than 30 micrograms/day of estradiol or equivalent in past 3 months
  • History of alcoholism or drug abuse in past year
  • Pregnant women or nursing mothers
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051558

Locations
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Loma Linda, California, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Palo Alto, California, United States
United States, Colorado
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Aurora, Colorado, United States
United States, North Dakota
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Jamestown, North Dakota, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Fargo, North Dakota, United States
United States, Wisconsin
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Milwaukee, Wisconsin, United States
Austria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Graz, Austria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Vienna, Austria
Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Brussels, Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Gent, Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Leuven, Belgium
Denmark
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Aarhus, Denmark
Norway
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Oslo, Norway
Puerto Rico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Ponce, Puerto Rico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician    
      Carolina, Puerto Rico

Sponsors and Collaborators
Eli Lilly and Company

Investigators
Study Director:     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    
  More Information

Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site
 

Publications indexed to this study:

Responsible Party:   Eli Lilly ( Chief Medical Officer )
Study ID Numbers:   6484, B3D-US-GHBZ
First Received:   January 13, 2003
Last Updated:   March 12, 2008
ClinicalTrials.gov Identifier:   NCT00051558
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Musculoskeletal Diseases
Teriparatide
Alendronate
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008




Links to all studies - primarily for crawlers