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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00557310
First received: November 9, 2007
Last updated: October 7, 2011
Last verified: October 2011

November 9, 2007
October 7, 2011
November 2007
October 2010   (final data collection date for primary outcome measure)
Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint [ Time Frame: Baseline, 18 months ] [ Designated as safety issue: No ]
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.
To test if treatment with teriparatide 20 mcg per day will increase a measure of bone topology (surface-to-curve ratio or SCR) in the distal radius as determined by magnetic resonance imaging (MRI) techniques in postmenopausal women with osteoporosis [ Time Frame: 18 months ]
Complete list of historical versions of study NCT00557310 on ClinicalTrials.gov Archive Site
  • Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 18, 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 18, 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 18, 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 3, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 18, 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 18, 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 18, 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 18, 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 18, 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 3, 6, 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 3, 6, 24 months ] [ Designated as safety issue: No ]
    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.
  • To assess changes in additional measures of bone topology in the distal radius including cortical thickness (CT), topological erosion index (TEI), and bone volume fraction (BV/TV) as determined by MRI techniques [ Time Frame: 18 months ]
  • To assess the time course of change in topological measures as determined by MRI techniques [ Time Frame: 18 months ]
  • To assess the change in volumetric bone mineral density (BMD) measured by quantitative computed tomography (QCT) of lumbar spine and hip and to estimate changes in vertebral and hip strength characteristics by finite element analysis [ Time Frame: 18 months ]
  • To assess BMD responses at the lumbar spine, femoral neck, total hip, and distal radius (1/3 and ultradistal sites) [ Time Frame: 18 months ]
  • To assess the change in biochemical markers of bone turnover including serum procollagen I N-terminal propeptide (PINP) and serum carboxyterminal cross-linking telopeptide of bone collagen (CTX) [ Time Frame: 3, 6 months ]
Not Provided
Not Provided
 
A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide
The Effects of Teriparatide on Bone Microarchitecture as Determined by High Resolution Magnetic Resonance Imaging and Digital Topological Analysis

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoporosis, Postmenopausal
Drug: teriparatide
20 mcg teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
Other Names:
  • LY333334
  • FORTEO
  • FORSTEO
Experimental: Teriparatide
20 micrograms (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
Intervention: Drug: teriparatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
May 2011
October 2010   (final data collection date for primary outcome measure)

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
Female
45 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00557310
11996, B3D-US-GHDJ
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP