Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Fractures Minerals Osteoporosis

Drug Information available for: Teriparatide Alendronate Teriparatide acetate Alendronate sodium Fosamax

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) [ Time Frame: 18 month endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset [ Time Frame: 18 month endpoint ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset [ Time Frame: 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin [ Time Frame: 1, 6, 18, and 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 ]

Enrollment:	428
Study Start Date:	November 2002
Study Completion Date:	January 2008
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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
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

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

Additional Information:

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

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Devogelaer JP, Adler RA, Recknor C, See K, Warner MR, Wong M, Krohn K. Baseline glucocorticoid dose and bone mineral density response with teriparatide or alendronate therapy in patients with glucocorticoid-induced osteoporosis. J Rheumatol. 2010 Jan;37(1):141-8. Epub 2009 Nov 16.

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:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00051558 History of Changes
Other Study ID Numbers:	6484, B3D-US-GHBZ
Study First Received:	January 13, 2003
Results First Received:	January 14, 2009
Last Updated:	February 13, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Glucocorticoids
Alendronate

Teriparatide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on February 12, 2012