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A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide

Primary Purpose

Osteoporosis, Postmenopausal

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
teriparatide
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal focused on measuring osteoporosis, teriparatide, postmenopausal, MRI, finite element analysis

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • postmenopausal (after the "change of life") women with osteoporosis
  • between the ages of 45-85
  • have low bone mass as determined by a bone density test
  • have at least one prior atraumatic vertebral or nonvertebral fracture(with a T-score of -2.0 or lower at the lumbar spine, total hip, or femoral neck) or, no prior fracture (with a T-score of -3.0 or lower at these same sites)
  • could have taken up to 5 years total of certain oral osteoporosis medications such as alendronate, risedronate, or ibandronate

Exclusion Criteria:

  • have conditions that would affect the bone in the region of the wrist or have had a previous fracture of either wrist which might affect results of study
  • have a metal implant or have had a hip replacement in either hip which might affect results of study
  • have an increased risk of osteosarcoma; includes Paget's disease of bone, a previous bone tumor, or x-ray treatment to the skeleton
  • currently have active or suspected diseases that affect the bone, other than osteoporosis
  • have abnormal levels of calcium, parathyroid hormone in blood, or other laboratory values

Sites / Locations

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Teriparatide

Arm Description

20 micrograms (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint
SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.

Secondary Outcome Measures

Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint
SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint
Cortical thickness (CT) is the thickness of both cortices in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint
TEI is the ratio of the sum of topological parameters expected to increase with bone erosion compared to the sum of those expected to decrease. The lower the value for TEI, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint
BV/TV is the estimate of the ratio of detectable bone relative to the total volume of the region of interest. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint
SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 3, 6, 12, 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint
Volumetric BMD is a measure of the amount of mineral in a given volume of bone, expressed as milligram per cubic centimeter (mg/cm³). Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint
Volumetric BMD is a measure of the amount of mineral in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint
Finite Element Analysis of computed tomography (CT) data from spine is used to estimate the strength of a vertebral body using a virtual axial load. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint
Finite Element Analysis of computed tomography (CT) data from hip is used to estimate the strength of the proximal femur with a virtual sideways fall. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint
Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint
Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint
Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint
Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint
Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint
PINP is a measure of bone formation. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint
CTX is a measure of bone resorption. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.

Full Information

First Posted
November 9, 2007
Last Updated
October 7, 2011
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00557310
Brief Title
A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide
Official Title
The Effects of Teriparatide on Bone Microarchitecture as Determined by High Resolution Magnetic Resonance Imaging and Digital Topological Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to use imaging technologies to demonstrate the effects of teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women with osteoporosis.
Detailed Description
As teriparatide is approved for up to 24 months of treatment in the US, patients will be given the option to continue in a 6-month extension phase upon completion of 18 months of teriparatide treatment. This extension will allow for collection of additional bone quality data. In Canada, the use of teriparatide is currently approved for 18 months. Patients in Canada may be given the opportunity to participate in the 6-month extension phase, contingent upon Health Canada approval of the use of teriparatide treatment for 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
Keywords
osteoporosis, teriparatide, postmenopausal, MRI, finite element analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teriparatide
Arm Type
Experimental
Arm Description
20 micrograms (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
Intervention Type
Drug
Intervention Name(s)
teriparatide
Other Intervention Name(s)
LY333334, FORTEO, FORSTEO
Intervention Description
20 mcg teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint
Description
SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time Frame
Baseline, 18 months
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint
Description
SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time Frame
Baseline, 24 months
Title
Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint
Description
Cortical thickness (CT) is the thickness of both cortices in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time Frame
Baseline, 18, 24 months
Title
Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint
Description
TEI is the ratio of the sum of topological parameters expected to increase with bone erosion compared to the sum of those expected to decrease. The lower the value for TEI, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time Frame
Baseline, 18, 24 months
Title
Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint
Description
BV/TV is the estimate of the ratio of detectable bone relative to the total volume of the region of interest. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time Frame
Baseline, 18, 24 months
Title
Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint
Description
SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 3, 6, 12, 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time Frame
Baseline, 3, 6, 12, 18, 24 months
Title
Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint
Description
Volumetric BMD is a measure of the amount of mineral in a given volume of bone, expressed as milligram per cubic centimeter (mg/cm³). Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time Frame
Baseline, 18 months
Title
Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint
Description
Volumetric BMD is a measure of the amount of mineral in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time Frame
Baseline, 18 months
Title
Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint
Description
Finite Element Analysis of computed tomography (CT) data from spine is used to estimate the strength of a vertebral body using a virtual axial load. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time Frame
Baseline, 18 months
Title
Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint
Description
Finite Element Analysis of computed tomography (CT) data from hip is used to estimate the strength of the proximal femur with a virtual sideways fall. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time Frame
Baseline, 18 months
Title
Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint
Description
Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time Frame
Baseline, 18, 24 months
Title
Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint
Description
Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time Frame
Baseline, 18, 24 months
Title
Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint
Description
Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time Frame
Baseline, 18, 24 months
Title
Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint
Description
Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time Frame
Baseline, 18, 24 months
Title
Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint
Description
Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time Frame
Baseline, 18, 24 months
Title
Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint
Description
PINP is a measure of bone formation. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time Frame
Baseline, 3, 6, 24 months
Title
Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint
Description
CTX is a measure of bone resorption. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time Frame
Baseline, 3, 6, 24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: postmenopausal (after the "change of life") women with osteoporosis between the ages of 45-85 have low bone mass as determined by a bone density test have at least one prior atraumatic vertebral or nonvertebral fracture(with a T-score of -2.0 or lower at the lumbar spine, total hip, or femoral neck) or, no prior fracture (with a T-score of -3.0 or lower at these same sites) could have taken up to 5 years total of certain oral osteoporosis medications such as alendronate, risedronate, or ibandronate Exclusion Criteria: have conditions that would affect the bone in the region of the wrist or have had a previous fracture of either wrist which might affect results of study have a metal implant or have had a hip replacement in either hip which might affect results of study have an increased risk of osteosarcoma; includes Paget's disease of bone, a previous bone tumor, or x-ray treatment to the skeleton currently have active or suspected diseases that affect the bone, other than osteoporosis have abnormal levels of calcium, parathyroid hormone in blood, or other laboratory values
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
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.
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80227
Country
United States
Facility Name
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.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
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.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
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.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
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.
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3X8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide

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