Trial · NCT00503399
Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis
NCT00503399, Phase 3, Completed, Eli Lilly and Company; results first posted 2011-11-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis. Trials, record NCT00503399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00503399
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis
- NCT number
- NCT00503399
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 92 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Osteoporosis
- Interventions
- Teriparatide, Risedronate
- First posted
- 2007-07-18
- Last updated
- 2012-03-13
- Results first posted
- 2011-11-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months | Baseline, 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. |
| Secondary | Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months | Baseline, 6 months | Least Squares (LS) Means were adjusted for age, baseline 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. |
| Secondary | 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 | Three-dimensional (3-D) microstructure variables of T12 were assessed by HR-QCT. In contrast with regular QCT that assessed 3 millimeter (mm) slide thickness, HR-QCT used segmentation of 1 single vertebra with approximately 100 consecutive slides reconstructed at 300-400 micrometer (µm) slice increments covering the complete vertebral body. Least Squares (LS) Means were adjusted for age, baseline 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. |
| Secondary | 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 | Anterior bending and axial torsion were measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline 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. |
| Secondary | 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 | Axial compression was measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated the strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline 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. |
| Secondary | Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months | Baseline, 18 months | Dual x-ray absorptiometry (DXA) techniques validated this measurement at skeletal sites that are at risk of osteoporotic fracture, such as lumbar spine, femoral neck, and hip. |
| Secondary | Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months | Baseline, 3 months, 6 months, 18 months | P1NP was used as a serum biochemical marker of collagen synthesis, reflecting the formation of new osteoid. |
| Secondary | Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months | 3, 6, 18 months | β-CTx was used as a biochemical marker of bone turnover/resorption, reflecting collagen breakdown of the bone matrix. |
| Secondary | Number of Participants With Adverse Events (AEs) | Baseline up to 18 months | Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. Fractures that occurred during the study were collected separately as an additional safety variable. The number of participants experiencing hypercalcemia was summarized for each treatment arm. Hypercalcemia was defined as a serum calcium level corrected for albumin of \>2.7 millimole per liter (mmol/L) (10.8 milligram per deciliter \[mg/dL\]). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months | Baseline, 18 months | The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit. | milligram per cubic centimeter (mg/cm^3) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months | Baseline, 6 months | The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit. | milligram per cubic centimeter (mg/cm^3) | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. | milligram per cubic centimeter (mg/cm^3) | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. | Newton/millimeter/radian (N/mm/rad) | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. | Newton per millimeter (N/mm) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months | Baseline, 18 months | The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. | grams per square centimeter (g/cm^2) | MEAN |
| SECONDARY | Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months | Baseline, 3 months, 6 months, 18 months | The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. | micrograms per deciliter (μg/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months | 3, 6, 18 months | The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. | nanograms per deciliter (ng/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Baseline up to 18 months | The safety analysis set included all participants who received study treatment. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months | Teriparatide | 12.28 | Standard Error 3.16 | milligram per cubic centimeter (mg/cm^3) | |
| Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months | Risedronate | 2.94 | Standard Error 3.14 | milligram per cubic centimeter (mg/cm^3) | |
| Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months | Teriparatide | 4.31 | Standard Error 3.15 | milligram per cubic centimeter (mg/cm^3) | |
| Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months | Risedronate | 2.52 | Standard Error 3.16 | milligram per cubic centimeter (mg/cm^3) | |
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 | Teriparatide | Integral BMD at 6 months | -0.42 | Standard Error 6.42 | milligram per cubic centimeter (mg/cm^3) |
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 | Risedronate | Integral BMD at 6 months | -1.91 | Standard Error 7.11 | milligram per cubic centimeter (mg/cm^3) |
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 | Teriparatide | Integral BMD at 18 months | 10.72 | Standard Error 6.22 | milligram per cubic centimeter (mg/cm^3) |
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 | Risedronate | Integral BMD at 18 months | 0.68 | Standard Error 7.08 | milligram per cubic centimeter (mg/cm^3) |
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 | Teriparatide | Trabecular BMD at 6 months | -0.70 | Standard Error 5.26 | milligram per cubic centimeter (mg/cm^3) |
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 | Risedronate | Trabecular BMD at 6 months | -0.87 | Standard Error 5.85 | milligram per cubic centimeter (mg/cm^3) |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Teriparatide | 45 | |
| Overall Study | STARTED | Risedronate | 47 | |
| Overall Study | COMPLETED | Teriparatide | 38 | |
| Overall Study | COMPLETED | Risedronate | 39 | |
| Overall Study | NOT COMPLETED | Teriparatide | 7 | |
| Overall Study | NOT COMPLETED | Risedronate | 8 |
Source ClinicalTrials.gov
Adverse events136
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 pain upper | Gastrointestinal disorders | Teriparatide | 0 | 45 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Risedronate | 2 | 47 | 2 |
| other | Constipation | Gastrointestinal disorders | Teriparatide | 1 | 45 | 1 |
| other | Constipation | Gastrointestinal disorders | Risedronate | 2 | 47 | 2 |
| other | Nausea | Gastrointestinal disorders | Teriparatide | 1 | 45 | 1 |
| other | Nausea | Gastrointestinal disorders | Risedronate | 3 | 47 | 3 |
| other | Reflux oesophagitis | Gastrointestinal disorders | Teriparatide | 1 | 45 | 1 |
| other | Reflux oesophagitis | Gastrointestinal disorders | Risedronate | 2 | 47 | 2 |
| other | Oedema peripheral | General disorders | Teriparatide | 3 | 45 | 4 |
| other | Oedema peripheral | General disorders | Risedronate | 2 | 47 | 2 |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teriparatide | ||
| Total, all-cause mortality | Risedronate | ||
| Total, other adverse events | Teriparatide | 22 | 45 |
| Total, other adverse events | Risedronate | 30 | 47 |
| Total, serious adverse events | Teriparatide | 13 | 45 |
| Total, serious adverse events | Risedronate | 22 | 47 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Teriparatide vs Risedronate: serious adverse events |
Source Trial comparisons
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/NCT00503399
GET https://conductscience.org/api/trials/v1/NCT00503399/results?page=2