Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Teriparatide (Drug); Risedronate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): 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, Affiliation: Eli Lilly and Company
Summary
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.
Clinical Details
Official title: Comparison of the Effects of Teriparatide With Those of Risedronate on Lumbar Spine vBMD in Glucocorticoid-Induced Osteoporosis in Men
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months
Secondary outcome: Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 MonthsChange 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 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 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 Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months Number of Participants With Adverse Events (AEs)
Detailed description:
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.
Eligibility
Minimum age: 25 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bad Nauheim 61231, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Frankfurt 60528, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Hamburg 22415, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Heinsberg 52525, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Leverkusen 51375, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Magdeburg 39110, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Potsdam 14469, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kifissia 14561, Greece
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Thessaloniki 56429, Greece
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Rome 00161, Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Siena 53100, Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Barcelona 08907, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Madrid 28046, Spain
Additional Information
Lilly Clinical Trial Registry
Starting date: July 2007
Last updated: March 12, 2012
|