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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT00557310 (opens ClinicalTrials.gov in a new tab)Other id11996Other idB3D-US-GHDJ
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
35 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
2 countries

United States, Canada

Start
Nov 2007
Primary completion
Oct 2010
Completion
May 2011
First posted
14 Nov 2007 (estimated)
Last update posted
11 Nov 2011 (estimated)
Conditions
Osteoporosis, Postmenopausal

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009201020112012
  1. Ph 4

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

    NCT00557310

    Nov 2007 to May 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • teriparatideDrug

Arms1

  • Experimental

    Teriparatide

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint

    Time frame · Baseline, 18 months

    Registry 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.

Secondary outcomes(16)

  1. Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint

    Time frame · Baseline, 24 months

    Registry 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.

  2. Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint

    Time frame · Baseline, 18, 24 months

    Registry 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.

  3. 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

    Registry 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.

  4. 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

    Registry 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.

  5. 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

    Registry 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.

  6. Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint

    Time frame · Baseline, 18 months

    Registry 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.

  7. Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint

    Time frame · Baseline, 18 months

    Registry 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.

  8. Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint

    Time frame · Baseline, 18 months

    Registry 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.

  9. Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint

    Time frame · Baseline, 18 months

    Registry 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.

  10. Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint

    Time frame · Baseline, 18, 24 months

    Registry 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.

  11. Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint

    Time frame · Baseline, 18, 24 months

    Registry 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.

  12. Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint

    Time frame · Baseline, 18, 24 months

    Registry 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.

  13. Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint

    Time frame · Baseline, 18, 24 months

    Registry 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.

  14. Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint

    Time frame · Baseline, 18, 24 months

    Registry 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.

  15. 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

    Registry 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.

  16. 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

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, 18 months

Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint

GroupValue (percent (%) change of ratio)Spread
Teriparatide4.534.89
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, 24 months

Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint

GroupValue (% change of ratio)Spread
Teriparatide1.446.88
Secondary outcomeLeast squares mean· Baseline, 18, 24 months

Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint

GroupValue (% change of millimeter (mm))Spread
Teriparatide-0.612.56
Secondary outcomeLeast squares mean· Baseline, 18, 24 months

Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint

GroupValue (% change of ratio)Spread
Teriparatide3.363.31
Secondary outcomeLeast squares mean· Baseline, 18, 24 months

Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint

GroupValue (% change of ratio)Spread
Teriparatide0.361.85
Secondary outcomeLeast squares mean· Baseline, 3, 6, 12, 18, 24 months

Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint

GroupValue (% change of ratio)Spread
Teriparatide-3.383.46
Secondary outcomeLeast squares mean· Baseline, 18 months

Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint

GroupValue (% change of mg/cm³)Spread
Teriparatide10.051.55
Secondary outcomeLeast squares mean· Baseline, 18 months

Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint

GroupValue (% change of mg/cm³)Spread
Teriparatide2.220.88

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Teriparatide20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months–5 / 3532 / 35

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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