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Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis (EuroGIOPS)
This study is ongoing, but not recruiting participants.
First Received: July 16, 2007   Last Updated: March 16, 2009   History of Changes
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00503399
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Drug: Teriparatide
Drug: Risedronate
Phase III

MedlinePlus related topics: Minerals Osteoporosis
Drug Information available for: Teriparatide Teriparatide acetate Risedronic acid Risedronate sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Comparison of the Effects of Teriparatide With Those of Risedronate on Lumbar Spine vBMD in Glucocorticoid-Induced Osteoporosis in Men

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Lumbar spine volumetric trabecular bone mineral density (BMD) by quantitative computerized tomography (QCT) [ Time Frame: From baseline to 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lumbar spine volumetric trabecular BMD by QCT [ Time Frame: At 6 months ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Biomechanical variables by finite element analysis in the 12 thoracic vertebra [ Time Frame: At baseline and 18 months ] [ Designated as safety issue: No ]
  • Areal bone mineral density at lumbar spine, femoral neck, and total hip [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Lumbar spine volumetric integral BMD by QCT [ Time Frame: 6 months, 18 months ] [ Designated as safety issue: No ]
  • Serum aminoterminal propeptide of type I procollagen (PINP) [ Time Frame: 3, 6, 18 months ] [ Designated as safety issue: No ]
  • Serum type I collagen degradation fragments [ Time Frame: 3, 6, 18 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 104
Study Start Date: July 2007
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: Teriparatide
Subcutaneous, 20 micrograms/day, 18 months
B: Active Comparator Drug: Risedronate
Oral, 35 mg/week, 18 months

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503399

Locations
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.
Bad Nauheim, Germany, 61231
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, Germany, 60528
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, Germany, 22415
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, Germany, 39110
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, Germany, 51375
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, Germany, 52525
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, Germany, 14469
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.
Kifissia, Greece, 14561
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, Greece, 56429
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.
Rome, Italy, 00161
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, Italy, 53100
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.
Barcelona, Spain, 08907
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, Spain, 28046
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 11716, B3D-EW-GHDH
Study First Received: July 16, 2007
Last Updated: March 16, 2009
ClinicalTrials.gov Identifier: NCT00503399     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices;   Greece: National Organization of Medicines;   Italy: Ethics Committee;   Spain: Spanish Agency of Medicines

Keywords provided by Eli Lilly and Company:
Glucocorticoid Induced

Study placed in the following topic categories:
Teriparatide
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Calcium Channel Blockers
Bone Diseases, Metabolic
Bone Density Conservation Agents
Cardiovascular Agents
Bone Diseases
Glucocorticoids
Hormones
Calcium, Dietary
Musculoskeletal Diseases
Risedronic acid

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Teriparatide
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Calcium Channel Blockers
Bone Diseases, Metabolic
Bone Density Conservation Agents
Cardiovascular Agents
Bone Diseases
Glucocorticoids
Hormones
Pharmacologic Actions
Membrane Transport Modulators
Musculoskeletal Diseases
Therapeutic Uses
Risedronic acid

ClinicalTrials.gov processed this record on May 07, 2009