Official Title: “Comparison of the Effects of Teriparatide With Those of Risedronate on Lumbar Spine vBMD in Glucocorticoid-Induced Osteoporosis in Men”

The objective of this study is to test the hypothesis that teriparatide is superior to the active comparator in the change from baseline to 18 months of lumbar spine volumetric trabecular bone mineral density in males with glucocorticoid-induced osteoporosis.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: August 2010

This study is a multinational, European, multicenter, randomized, open-label, active comparator controlled study with two study periods: a screening phase of up to 6 weeks, and an open-label treatment phase of 18 months. Approximately 100 adult men with osteoporosis associated with sustained glucocorticoid therapy will be enrolled into the study.

Approximately one half of the patients (at all investigational sites) will be randomized to teriparatide 20 micrograms/day (given as a subcutaneous injection), and the other half randomized to risedronate 35 mg once weekly oral tablet. All patients will receive approximately 1000 mg/day elemental calcium and 800 to 1200 IU/day of vitamin D.

Intervention(s) in this Clinical Trial

• Drug: Teriparatide
  • Subcutaneous, 20 micrograms/day, 18 months
• Drug: Risedronate
  • Oral, 35 mg/week, 18 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Active Comparator: B

Primary Measures

• Lumbar spine volumetric trabecular bone mineral density (BMD) by quantitative computerized tomography (QCT)
  • Time Frame: From baseline to 18 months
    Safety Issue?: No

Secondary Measures

• Lumbar spine volumetric trabecular BMD by QCT
  • Time Frame: At 6 months
    Safety Issue?: No
• 3-D microstructure variables by high-resolution QCT (HR-QCT)in the 12th thoracic vertebra (T12)
  • Time Frame: At baseline, 6 and 18 months
    Safety Issue?: No
• Biomechanical variables by finite element analysis in the 12 thoracic vertebra
  • Time Frame: At baseline and 18 months
    Safety Issue?: No
• Areal bone mineral density at lumbar spine, femoral neck, and total hip
  • Time Frame: 18 months
    Safety Issue?: No
• Lumbar spine volumetric integral BMD by QCT
  • Time Frame: 6 months, 18 months
    Safety Issue?: No
• Serum aminoterminal propeptide of type I procollagen (PINP)
  • Time Frame: 3, 6, 18 months
    Safety Issue?: No
• Serum type I collagen degradation fragments
  • Time Frame: 3, 6, 18 months
    Safety Issue?: No
• Safety
  • Time Frame: Throughout study
    Safety Issue?: Yes

Inclusion Criteria:

• Ambulatory men 25 years of age and older presenting to Visit 1 with a BMD of at least 1.5 SD below the corresponding normal young adult men average BMD (T score of -1.5 or lower), as determined from the manufacturer's database at any of the following regions of interest: total hip, femoral neck, or lumbar spine
• Have received glucocorticoid therapy at an average dose of at least 5.0 mg/day of prednisone or its equivalent for a minimum of 3 consecutive months immediately preceding screening (Visit 1), as determined by medical history.
• A minimum of 2 lumbar vertebrae in the L-1 through L-3 region must be evaluable by quantitative computerized tomography.
• Normal or clinically insignificant abnormal laboratory values (as determined by the investigator) including serum calcium, PTH(1 84), and 25 hydroxyvitamin D concentrations, and alkaline phosphatase activity.

Exclusion Criteria:

• Presence of a mild, moderate or severe spinal fracture in both T-12 and L-1, as determined by the central reading facility using the semiquantitative technique.
• Abnormal albumin-corrected serum calcium levels
• History of unresolved skeletal diseases that affect bone metabolism other than glucocorticoid-induced osteoporosis
• History of malignant neoplasms in the 5 years prior to Visit 2, with the exception of superficial basal cell or squamous cell carcinomas of the skin that have been definitively treated. Increased baseline risk of osteosarcoma; this includes patients with Paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation.
• Abnormal thyroid function not corrected by therapy
• Past and/or current treatment with certain medications.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 25 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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00503399

Study ID Number: 11716

ClinicalTrials.gov Identifier: NCT00503399

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Lilly Clinical Trial Registry