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Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
This study has been completed.
Study NCT00051558   Information provided by Eli Lilly and Company
First Received: January 13, 2003   Last Updated: February 13, 2009   History of Changes

January 13, 2003
February 13, 2009
November 2002
July 2006   (final data collection date for primary outcome measure)
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) [ Time Frame: 18 month endpoint ] [ Designated as safety issue: No ]
  • - Whether the increase from baseline to 18 months in lumbar spine BMD induced by teriparatide statistically signficantly exceeds that obtained with alendronate in women and men taking GC for a minimum of 3 months
  • To determine:
Complete list of historical versions of study NCT00051558 on ClinicalTrials.gov Archive Site
  • 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 ]
  • - 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 of the therapies 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 months 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 from a subset of the study centers
  • - 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
 
Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis

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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Osteoporosis
  • Drug: Teriparatide
  • Drug: Alendronate Sodium
  • Drug: Placebo
  • Experimental: Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
  • Active Comparator: Alendronate 10 mg/day oral plus injection placebo, 36 months
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
428
January 2008
July 2006   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Denmark,   Norway,   Puerto Rico
 
NCT00051558
Chief Medical Officer, Eli Lilly
6484, B3D-US-GHBZ
Eli Lilly and Company
 
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
Eli Lilly and Company
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP