Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis

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 (BMD) in males with glucocorticoid-induced osteoporosis.

This study is a multinational, European, multicenter, randomized, open-label, active comparator controlled study with 2 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 participants (at all investigational sites) will be randomized to teriparatide 20 micrograms/day (ug/day given as a subcutaneous (sc) injection), and the other half randomized to risedronate 35 milligrams (mg) once weekly (QW) oral (po) tablet.

All participants will receive approximately 1000 mg/day elemental calcium and 800 to 1200 international units per day (IU/day) of vitamin D.

Intervention(s) in this Clinical Trial

• Drug: Teriparatide
  • 20 µg/day sc for 18 months
• Drug: Risedronate
  • 35 mg/week po for 18 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Teriparatide
  • Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD).
• Active Comparator: Risedronate
  • Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)

Primary Measures

• Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months
  • Time Frame: Baseline, 18 months
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months
  • Time Frame: Baseline, 6 months
    Safety Issue?: No
• Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months
  • Time Frame: Baseline, 6 months, 18 months
    Safety Issue?: No
• Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
  • Time Frame: Baseline, 6 months, 18 months
    Safety Issue?: No
• Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
  • Time Frame: Baseline, 6 months, 18 months
    Safety Issue?: No
• Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months
  • Time Frame: Baseline, 18 months
    Safety Issue?: No
• Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months
  • Time Frame: Baseline, 3 months, 6 months, 18 months
    Safety Issue?: No
• Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months
  • Time Frame: 3, 6, 18 months
    Safety Issue?: No
• Number of Participants With Adverse Events (AEs)
  • Time Frame: Baseline up to 18 months
    Safety Issue?: Yes

Inclusion Criteria:

• Ambulatory men 25 years of age and older presenting to Visit 1 with a bone mineral density (BMD) of at least 1.5 standard deviation (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 milligrams (mg) per 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 (L) 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, parathyroid hormone (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 the twelfth thoracic vertebra (T-12) and first lumbar vertebra (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 Investigator: Eli Lilly and Company Industry

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 February 09, 2012

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