Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Drug: Teriparatide
  • 20 micrograms/day, injection, 36 months
• Drug: Alendronate Sodium
  • 10 mg/day, oral, 36 months
• Drug: Placebo
  • Oral placebo, daily, 36 months
• Drug: Placebo
  • Injection placebo, daily, 36 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
• Active Comparator: B
  • Alendronate 10 mg/day oral plus injection placebo, 36 months

Primary 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
    Safety Issue?: No

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

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) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00051558

Study ID Number: 6484

ClinicalTrials.gov Identifier: NCT00051558

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry