Trial · NCT00557310
A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide
NCT00557310, Phase 4, Completed, Eli Lilly and Company; results first posted 2011-11-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide. Trials, record NCT00557310. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00557310
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide
- NCT number
- NCT00557310
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 35 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Osteoporosis, Postmenopausal
- Interventions
- teriparatide
- First posted
- 2007-11-14
- Last updated
- 2011-11-11
- Results first posted
- 2011-11-11
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint | Baseline, 18 months | 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 | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint | Baseline, 24 months | 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. |
| Secondary | Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint | Baseline, 18, 24 months | 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. |
| Secondary | Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint | Baseline, 18, 24 months | 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. |
| Secondary | Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint | Baseline, 18, 24 months | 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. |
| Secondary | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint | Baseline, 3, 6, 12, 18, 24 months | 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. |
| Secondary | Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint | Baseline, 18 months | 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. |
| Secondary | Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint | Baseline, 18 months | 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. |
| Secondary | Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint | Baseline, 18 months | 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. |
| Secondary | Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint | Baseline, 18 months | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint | Baseline, 18 months | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | percent (%) change of ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint | Baseline, 24 months | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | % change of ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint | Baseline, 18, 24 months | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | % change of millimeter (mm) | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint | Baseline, 18, 24 months | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | % change of ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint | Baseline, 18, 24 months | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | % change of ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint | Baseline, 3, 6, 12, 18, 24 months | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | % change of ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint | Baseline, 18 months | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | % change of mg/cm³ | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint | Baseline, 18 months | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | % change of mg/cm³ | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint | Baseline, 18 months | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | % change of Newtons | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint | Baseline, 18 months | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | % change of Newtons | LEAST_SQUARES_MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint | Teriparatide | 4.53 | Standard Error 4.89 | percent (%) change of ratio | |
| Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint | Teriparatide | 1.44 | Standard Error 6.88 | % change of ratio | |
| Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint | Teriparatide | 18 month percent change (n=25) | -0.61 | Standard Error 2.56 | % change of millimeter (mm) |
| Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint | Teriparatide | 24 month percent change (n=21) | -0.22 | Standard Error 2.59 | % change of millimeter (mm) |
| Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint | Teriparatide | 18 month percent change (n=25) | 3.36 | Standard Error 3.31 | % change of ratio |
| Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint | Teriparatide | 24 month percent change (n=21) | 8.46 | Standard Error 4.63 | % change of ratio |
| Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint | Teriparatide | 18 month percent change (n=25) | 0.36 | Standard Error 1.85 | % change of ratio |
| Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint | Teriparatide | 24 month percent change (n=21) | -3.14 | Standard Error 2.40 | % change of ratio |
| Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint | Teriparatide | 3 month percent change (n=32) | -3.38 | Standard Error 3.46 | % change of ratio |
| Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint | Teriparatide | 6 month percent change (n=30) | 0.43 | Standard Error 4.05 | % change of ratio |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study (0 - 18 Months) | STARTED | Teriparatide | 35 | |
| Main Study (0 - 18 Months) | COMPLETED | Teriparatide | 30 | |
| Main Study (0 - 18 Months) | NOT COMPLETED | Teriparatide | 5 | |
| Extension Phase (18 - 24 Months) | STARTED | Teriparatide | 30 | |
| Extension Phase (18 - 24 Months) | COMPLETED | Teriparatide | 25 | |
| Extension Phase (18 - 24 Months) | NOT COMPLETED | Teriparatide | 5 |
Source ClinicalTrials.gov
Adverse events38
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Teriparatide | 2 | 35 | 2 |
| other | Constipation | Gastrointestinal disorders | Teriparatide | 3 | 35 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Teriparatide | 3 | 35 | 3 |
| other | Nausea | Gastrointestinal disorders | Teriparatide | 2 | 35 | 2 |
| other | Vomiting | Gastrointestinal disorders | Teriparatide | 2 | 35 | 2 |
| other | Injection site haematoma | General disorders | Teriparatide | 2 | 35 | 2 |
| other | Malaise | General disorders | Teriparatide | 2 | 35 | 2 |
| other | Seasonal allergy | Immune system disorders | Teriparatide | 2 | 35 | 2 |
| other | Bronchitis | Infections and infestations | Teriparatide | 2 | 35 | 2 |
| other | Diverticulitis | Infections and infestations | Teriparatide | 2 | 35 | 2 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teriparatide | ||
| Total, other adverse events | Teriparatide | 32 | 35 |
| Total, serious adverse events | Teriparatide | 5 | 35 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00557310
GET https://conductscience.org/api/trials/v1/NCT00557310/results?page=2