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Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

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ClinicalTrials.gov Identifier: NCT00051558
Recruitment Status : Completed
First Posted : January 14, 2003
Results First Posted : February 13, 2009
Last Update Posted : March 12, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Teriparatide Drug: Alendronate Sodium Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis
Study Start Date : November 2002
Actual Primary Completion Date : July 2006
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
 Drug: Teriparatide
20 micrograms/day, injection, 36 months
Other Names:
  • LY333334
  • Forteo
  • Forsteo

Drug: Placebo
Oral placebo, daily, 36 months
Active Comparator: B
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


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) [ Time Frame: 18 month endpoint ]
    change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)


Secondary Outcome Measures :
  1. Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset [ Time Frame: 18 month endpoint ]
    change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

  2. Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined [ Time Frame: 3, 6, 12, 18, 24, 36 months ]
    change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

  3. Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset [ Time Frame: 3, 6, 12, and 18 months ]
    change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

  4. Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined [ Time Frame: 24 and 36 months and Endpoint at 36 months ]
    change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

  5. Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined [ Time Frame: 18, 24, 36 months, and 18 and 36 month endpoints ]
    change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)

  6. Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined [ Time Frame: 18, 24, 36 months, and 18 and 36 month endpoints ]
    change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)

  7. Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined [ Time Frame: 12, 18, 24, and 36 months ]
    change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)

  8. Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined [ Time Frame: 12, 18, 24, and 36 months ]
    change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)

  9. Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen [ Time Frame: 1, 6, 18, and 36 months ]
  10. Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen [ Time Frame: 1, 6, 18, and 36 months ]
  11. Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase [ Time Frame: 1, 6, 18, and 36 months ]
  12. Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments [ Time Frame: 1, 6, 18, and 36 months ]
  13. Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin [ Time Frame: 1, 6, 18, and 36 months ]
  14. Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures [ Time Frame: 36 months ]
    Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051558


Locations
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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
Fargo, 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
Jamestown, 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
Carolina, 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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00051558    
Other Study ID Numbers: 6484
B3D-US-GHBZ
First Posted: January 14, 2003    Key Record Dates
Results First Posted: February 13, 2009
Last Update Posted: March 12, 2009
Last Verified: February 2009
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
 Alendronate
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents