Trial · NCT00259298
Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis
NCT00259298, Phase 4, Completed, Eli Lilly and Company; results first posted 2010-08-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis. Trials, record NCT00259298. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00259298
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis
- NCT number
- NCT00259298
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 12 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Osteoporosis
- Interventions
- teriparatide
- First posted
- 2005-11-29
- Last updated
- 2010-08-11
- Results first posted
- 2010-08-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months | baseline, 18 months | Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone). |
| Secondary | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Baseline, 3 months, 18 months, 24 months | Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone) and to derive regional values for the skull, mandible, spine, pelvis, and upper and lower extremities. |
| Secondary | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Baseline, 3 months, 18 months, 24 months | Skeletal uptake describes the percent uptake of radionuclide tracer by the skeleton when compared to baseline or other post-baseline measures. Skeletal uptake is defined as percentage of uptake of 99mTc-MDP 4 hours after injection. This value differs from skeletal plasma clearance measurements because it only quantifies the amount of 99mTc-MDP taken up by bone without consideration of concentration of tracer in the plasma. |
| Secondary | Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton | Baseline, 3 months, 18 months, 24 months | Changes in focal uptake (localized, defined areas of uptake) were visually scored and compared to baseline or other post-baseline assessments. Changes were rated on a scale from 0-4: 0=no clinically significant focal areas of skeletal uptake; 1=focal areas affecting \<1% of skeleton; 2=focal areas affecting \>=5% of skeleton; 3=focal areas affecting \>=20% of skeleton; 4=focal areas affecting \>=50% of skeleton. |
| Secondary | Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton | baseline, 3 months, 18 months, 24 months | Changes in diffuse uptake were determined by comparing diffuse uptake to baseline or other post-baseline observations. Diffuse uptake indicates response to therapy (during active treatment, increased diffuse uptake was expected; after the 6-month withdrawal period, decreased diffuse uptake was expected). Qualitative visual scoring of changes in the bone scan images were performed jointly by 3 reviewers who classified changes in the whole skeleton into 4 groups as follows: possible decreased response, no response, possible response, and definite response. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Baseline, 3 months, 18 months, 24 months | All participants with a baseline observation and at least 1 post-baseline observation. | percentage of change of plasma clearance | MEDIAN |
| SECONDARY | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Baseline, 3 months, 18 months, 24 months | All participants with a baseline observation and at least 1 post-baseline observation. | percentage of change of skeletal uptake | MEDIAN |
| SECONDARY | Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton | Baseline, 3 months, 18 months, 24 months | All participants with a baseline observation and at least 1 post-baseline observation. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton | baseline, 3 months, 18 months, 24 months | All participants with a baseline observation and at least 1 post-baseline observation. | participants | NUMBER |
| PRIMARY | Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months | baseline, 18 months | All participants with a baseline observation and at least 1 post-baseline observation. | percentage of change of plasma clearance | MEDIAN |
Source ClinicalTrials.gov
Results by group85
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Teriparatide | Whole skeleton, baseline to 3 months, n=10 | 25.02 | Inter-Quartile Range 14.21 to 30.73 | percentage of change of plasma clearance |
| Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Teriparatide | Whole skeleton, baseline to 24 months, n=9 | 3.52 | Inter-Quartile Range -8.27 to 11.93 | percentage of change of plasma clearance |
| Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Teriparatide | Whole skeleton, 3 months to 18 months, n=10 | 10.44 | Inter-Quartile Range 7.83 to 21.00 | percentage of change of plasma clearance |
| Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Teriparatide | Whole skeleton, 18 months to 24 months, n=9 | -22.20 | Inter-Quartile Range -24.35 to -18.39 | percentage of change of plasma clearance |
| Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Teriparatide | Skull, baseline to 3 months, n=8 | 72.25 | Inter-Quartile Range 42.19 to 106.56 | percentage of change of plasma clearance |
| Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Teriparatide | Skull, baseline to 18 months, n=8 | 128.44 | Inter-Quartile Range 97.38 to 162.55 | percentage of change of plasma clearance |
| Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Teriparatide | Skull, baseline to 24 months, n=7 | 21.20 | Inter-Quartile Range 8.00 to 54.90 | percentage of change of plasma clearance |
| Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Teriparatide | Skull, 3 months to 18 months, n=8 | 31.01 | Inter-Quartile Range 17.65 to 47.29 | percentage of change of plasma clearance |
| Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Teriparatide | Skull, 18 months to 24 months, n=7 | -37.87 | Inter-Quartile Range -45.64 to -32.14 | percentage of change of plasma clearance |
| Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Teriparatide | Mandible, baseline to 3 months, n=8 | 65.94 | Inter-Quartile Range 26.56 to 106.76 | percentage of change of plasma clearance |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Teriparatide | 12 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Teriparatide | 10 | |
| Overall Study | COMPLETED | Teriparatide | 9 | |
| Overall Study | NOT COMPLETED | Teriparatide | 3 |
Source ClinicalTrials.gov
Adverse events90
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 | Arrhythmia | Cardiac disorders | Teriparatide | 2 | 12 | 3 |
| other | Palpitations | Cardiac disorders | Teriparatide | 1 | 12 | 1 |
| other | Tachycardia | Cardiac disorders | Teriparatide | 1 | 12 | 1 |
| other | Ear disorder | Ear and labyrinth disorders | Teriparatide | 1 | 12 | 1 |
| other | Eustachian tube obstruction | Ear and labyrinth disorders | Teriparatide | 1 | 12 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Teriparatide | 2 | 12 | 2 |
| other | Vertigo | Ear and labyrinth disorders | Teriparatide | 1 | 12 | 2 |
| other | Blepharitis | Eye disorders | Teriparatide | 1 | 12 | 1 |
| other | Cataract | Eye disorders | Teriparatide | 1 | 12 | 1 |
| other | Chorioretinal disorder | Eye disorders | Teriparatide | 1 | 12 | 1 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 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 | 12 | 12 |
| Total, serious adverse events | Teriparatide | 1 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19929434 | DERIVED |
Source PubMed
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/NCT00259298
GET https://conductscience.org/api/trials/v1/NCT00259298/results?page=2