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	Treatment or Intervention	Phase
Osteoporosis	Drug: Study drug or Alendronate Sodium	Phase III

Further Study Details: 

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Both

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

There may be multiple sites in this clinical trial      1-877-CTLILLY (1-877-285-4559) 

California
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559 or speak with your personal physician., Loma Linda,  California,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559 or speak with your personal physician., Palo Alto,  California,  United States; Recruiting
Colorado
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Aurora,  Colorado,  United States; Recruiting
North Dakota
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559 or speak with your personal physician., Jamestown,  North Dakota,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Fargo,  North Dakota,  United States; Recruiting
Wisconsin
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559 or speak with your personal physician., Milwaukee,  Wisconsin,  United States; Recruiting
Austria
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Graz,  Austria; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Vienna,  Austria; Recruiting
Belgium
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Brussels,  Belgium; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Gent,  Belgium; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Leuven,  Belgium; Recruiting
Denmark
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Aarhus,  Denmark; Recruiting
Norway
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Oslo,  Norway; Recruiting
Puerto Rico
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Ponce,  Puerto Rico; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Carolina,  Puerto Rico; Recruiting

Study ID Numbers:  6484
Record last reviewed:  January 2005
Last Updated:  April 1, 2005
Record first received:  January 13, 2003
ClinicalTrials.gov Identifier:  NCT00051558
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08