Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Jul 2007

Typical duration for phase_3

Geographic Reach

4 countries

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

Study Start

First participant enrolled

July 1, 2007

Completed

15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

November 8, 2011

Completed

Last Updated

March 13, 2012

Status Verified

October 1, 2011

Enrollment Period

3.3 years

First QC Date

July 16, 2007

Results QC Date

October 4, 2011

Last Update Submit

March 12, 2012

Conditions

Osteoporosis

Keywords

Glucocorticoid Induced

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months
Least Squares (LS) Means were adjusted for age, baseline serum aminoterminal propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.
Baseline, 18 months

Secondary Outcomes (8)

Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months
Baseline, 6 months
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
Baseline, 6 months, 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
Baseline, 6 months, 18 months
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
Baseline, 6 months, 18 months
Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months
Baseline, 18 months
+3 more secondary outcomes

Study Arms (2)

Teriparatide

EXPERIMENTAL

Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD).

Drug: Teriparatide

Risedronate

ACTIVE COMPARATOR

Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)

Drug: Risedronate

Interventions

TeriparatideDRUG

20 µg/day sc for 18 months

Also known as: LY333334, Forteo, Forsteo

Teriparatide

RisedronateDRUG

35 mg/week po for 18 months

Also known as: Actonel

Risedronate

Eligibility Criteria

Age25 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (13)

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

Location

Frankfurt, 60528, Germany

Location

Hamburg, 22415, Germany

Location

Heinsberg, 52525, Germany

Location

Leverkusen, 51375, Germany

Location

Magdeburg, 39110, Germany

Location

Potsdam, 14469, Germany

Location

Kifissia, 14561, Greece

Location

Thessaloniki, 56429, Greece

Location

Rome, 00161, Italy

Location

Siena, 53100, Italy

Location

Barcelona, 08907, Spain

Location

Madrid, 28046, Spain

Location

Related Publications (2)

Gluer CC, Marin F, Ringe JD, Hawkins F, Moricke R, Papaioannu N, Farahmand P, Minisola S, Martinez G, Nolla JM, Niedhart C, Guanabens N, Nuti R, Martin-Mola E, Thomasius F, Kapetanos G, Pena J, Graeff C, Petto H, Sanz B, Reisinger A, Zysset PK. Comparative effects of teriparatide and risedronate in glucocorticoid-induced osteoporosis in men: 18-month results of the EuroGIOPs trial. J Bone Miner Res. 2013 Jun;28(6):1355-68. doi: 10.1002/jbmr.1870.
PMID: 23322362DERIVED
Graeff C, Marin F, Petto H, Kayser O, Reisinger A, Pena J, Zysset P, Gluer CC. High resolution quantitative computed tomography-based assessment of trabecular microstructure and strength estimates by finite-element analysis of the spine, but not DXA, reflects vertebral fracture status in men with glucocorticoid-induced osteoporosis. Bone. 2013 Feb;52(2):568-77. doi: 10.1016/j.bone.2012.10.036. Epub 2012 Nov 10.
PMID: 23149277DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

TeriparatideRisedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 18, 2007

Study Start

July 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

March 13, 2012

Results First Posted

November 8, 2011

Record last verified: 2011-10

Locations

IT(2)GR(2)DE(7)ES(2)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Teriparatide

Risedronate

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Teriparatide

Risedronate

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations