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Comparison of Teriparatide With Alendronate for Treating 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 (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.


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

MedlinePlus related topics:   Fractures    Minerals    Osteoporosis   

Drug Information available for:   Alendronate    Alendronate sodium    Teriparatide    Teriparatide acetate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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:
  • Change in lumbar spine bone mineral density (BMD) induced by teriparatide statistically significantly exceeds that obtained with alendronate in patients taking glucocorticoids (GC) for at least 3 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in lumbar spine BMD, female subset [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Time course of change in lumbar spine BMD, women and men combined [ Time Frame: 18, 36 months ] [ Designated as safety issue: No ]
  • Time course of change in lumbar spine BMD, female subset [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change in lumbar spine BMD [ Time Frame: 24 and 36 months ] [ Designated as safety issue: No ]
  • Change in femoral neck BMD [ Time Frame: 18, 24, 36 months ] [ Designated as safety issue: No ]
  • Change in total hip BMD [ Time Frame: 18, 24, 36 months ] [ Designated as safety issue: No ]
  • Time course of change in femoral neck BMD [ Time Frame: 18, 36 months ] [ Designated as safety issue: No ]
  • Time course of change in total hip BMD [ Time Frame: 18, 36 months ] [ Designated as safety issue: No ]
  • Time course of change in bone turnover markers in subset of patients [ Time Frame: 18, 36 months ] [ Designated as safety issue: No ]
  • Any fracture, nonvertebral fractures, vertebral fractures, clinical vertebral fractures, and severity fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Adverse experiences, laboratory variables and other subject safety and tolerance of the study drugs [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment:   428
Study Start Date:   November 2002
Study Completion Date:   January 2008
Primary Completion Date:   January 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
Drug: Teriparatide
20 micrograms/day, injection, 36 months
Drug: Placebo
Oral placebo, daily, 36 months
B: Active Comparator
Alendronate 10 mg/day oral plus injection placebo, 36 months
Drug: Alendronate Sodium
10 mg/day, oral, 36 months
Drug: Placebo
Injection placebo, daily, 36 months

  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 for at least 3 months prior to screening

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:
Saag KG, Shane E, Boonen S, Marín F, Donley DW, Taylor KA, Dalsky GP, Marcus R. Teriparatide or alendronate in glucocorticoid-induced osteoporosis. N Engl J Med. 2007 Nov 15;357(20):2028-39.
 

Responsible Party:   Eli Lilly ( Chief Medical Officer )
Study ID Numbers:   6484, B3D-US-GHBZ
First Received:   January 13, 2003
Last Updated:   September 10, 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 November 20, 2008

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