Trial · NCT00433160
Phase 3 Clinical Trial of Teriparatide in Japan
NCT00433160, Phase 3, Completed, Eli Lilly and Company; results first posted 2009-09-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Clinical Trial of Teriparatide in Japan. Trials, record NCT00433160. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00433160
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Clinical Trial of Teriparatide in Japan
- NCT number
- NCT00433160
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 207 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Osteoporosis
- Interventions
- Teriparatide, Placebo
- First posted
- 2007-02-09
- Last updated
- 2010-09-21
- Results first posted
- 2009-09-30
- Limitations and caveats
- Original data presented were for the 52-week double-blinded treatment phase; results of the open label phases at 76 weeks and 104 weeks have now been added
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) | Baseline to 52 weeks | Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point. |
| Secondary | Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) | Baseline to 52 Weeks | Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point. |
| Secondary | Percent Change in Bone Mineral Density (BMD) at Total Hip | Baseline to 52 Weeks | Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point. |
| Secondary | Percent Change in Bone Mineral Density (BMD) at Femoral Neck | Baseline to 52 Weeks | Percent change in bone mineral density at femoral neck from baseline to the last measurement point. |
| Secondary | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Baseline to Weeks 4, 12, 24, and 52 | Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point. |
| Secondary | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Baseline to Weeks 4, 12, 24, 52 | Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point. |
| Secondary | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Baseline to Weeks 4, 12, 24, 52 | Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point. |
| Secondary | Vertebral Fractures by Central X-ray Assessment | Baseline through 52 weeks | Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted. |
| Secondary | Fractures by Investigators Assessment | Baseline through 52 Weeks | Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma. |
| Secondary | Back Pain Severity | Baseline, Weeks 12, 24, 36, 52 | Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe). |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) | Baseline to 52 weeks | Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement. | percent change in BMD | MEAN |
| SECONDARY | Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) | Baseline to 52 Weeks | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | percent change in BMD | MEAN |
| SECONDARY | Percent Change in Bone Mineral Density (BMD) at Total Hip | Baseline to 52 Weeks | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | percent change in BMD | MEAN |
| SECONDARY | Percent Change in Bone Mineral Density (BMD) at Femoral Neck | Baseline to 52 Weeks | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | percent change in BMD | MEAN |
| SECONDARY | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Baseline to Weeks 4, 12, 24, and 52 | Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement. | percent change in PINP | MEAN |
| SECONDARY | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Baseline to Weeks 4, 12, 24, 52 | Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement. | percent change in BAP | MEAN |
| SECONDARY | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Baseline to Weeks 4, 12, 24, 52 | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | percent change in CTX | MEAN |
| SECONDARY | Vertebral Fractures by Central X-ray Assessment | Baseline through 52 weeks | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. The n's are the number of participants with fractures. | number of fractures | NUMBER |
| SECONDARY | Fractures by Investigators Assessment | Baseline through 52 Weeks | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | number of fractures | NUMBER |
| SECONDARY | Back Pain Severity | Baseline, Weeks 12, 24, 36, 52 | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group154
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) | Teriparatide | Percent Change to Last Measurement Point | 9.82 | Standard Deviation 5.36 | percent change in BMD |
| Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) | Placebo | Percent Change to Last Measurement Point | 0.04 | Standard Deviation 4.34 | percent change in BMD |
| Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) | Teriparatide | Percent Change to Last Measurement Point | 10.23 | Standard Deviation 5.74 | percent change in BMD |
| Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) | Placebo | Percent Change to Last Measurement Point | 0.11 | Standard Deviation 4.42 | percent change in BMD |
| Percent Change in Bone Mineral Density (BMD) at Total Hip | Teriparatide | Percent Change to Last Measurement Point | 2.66 | Standard Deviation 4.22 | percent change in BMD |
| Percent Change in Bone Mineral Density (BMD) at Total Hip | Placebo | Percent Change to Last Measurement Point | -0.22 | Standard Deviation 3.38 | percent change in BMD |
| Percent Change in Bone Mineral Density (BMD) at Femoral Neck | Teriparatide | Percent Change to Last Measurement Point | 2.24 | Standard Deviation 6.01 | percent change in BMD |
| Percent Change in Bone Mineral Density (BMD) at Femoral Neck | Placebo | Percent Change to Last Measurement Point | 0.46 | Standard Deviation 3.89 | percent change in BMD |
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Teriparatide | Percent Change to Week 4 (n=136, n=66) | 90.67 | Standard Deviation 49.85 | percent change in PINP |
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Placebo | Percent Change to Week 4 (n=136, n=66) | -9.58 | Standard Deviation 14.39 | percent change in PINP |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 52-Week Double-Blind (DB) Period | STARTED | Teriparatide | 137 | |
| 52-Week Double-Blind (DB) Period | STARTED | Placebo | 70 | |
| 52-Week Double-Blind (DB) Period | Received Treatment | Teriparatide | 136 | |
| 52-Week Double-Blind (DB) Period | Received Treatment | Placebo | 68 | |
| 52-Week Double-Blind (DB) Period | COMPLETED | Teriparatide | 120 | |
| 52-Week Double-Blind (DB) Period | COMPLETED | Placebo | 60 | |
| 52-Week Double-Blind (DB) Period | NOT COMPLETED | Teriparatide | 17 | |
| 52-Week Double-Blind (DB) Period | NOT COMPLETED | Placebo | 10 | |
| 76 Weeks, 24-Week Open Label (OL) Period | STARTED | Teriparatide | 119 | |
| 76 Weeks, 24-Week Open Label (OL) Period | STARTED | Placebo | 59 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events318
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 | Constipation | Gastrointestinal disorders | Teriparatide (During 52 Weeks) | 10 | 136 | 11 |
| other | Constipation | Gastrointestinal disorders | Placebo (During 52 Weeks) | 2 | 67 | 3 |
| other | Constipation | Gastrointestinal disorders | Teriparatide (During 76 Weeks) | 11 | 136 | 13 |
| other | Constipation | Gastrointestinal disorders | Placebo (During 76 Weeks) | 4 | 67 | 5 |
| other | Constipation | Gastrointestinal disorders | Teriparatide (During 104 Weeks) | 12 | 136 | 14 |
| other | Constipation | Gastrointestinal disorders | Placebo (During 104 Weeks) | 5 | 67 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Teriparatide (During 52 Weeks) | 6 | 136 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (During 52 Weeks) | 0 | 67 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Teriparatide (During 76 Weeks) | 7 | 136 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (During 76 Weeks) | 4 | 67 | 4 |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teriparatide (During 52 Weeks) | ||
| Total, all-cause mortality | Placebo (During 52 Weeks) | ||
| Total, all-cause mortality | Teriparatide (During 76 Weeks) | ||
| Total, all-cause mortality | Placebo (During 76 Weeks) | ||
| Total, all-cause mortality | Teriparatide (During 104 Weeks) | ||
| Total, all-cause mortality | Placebo (During 104 Weeks) | ||
| Total, other adverse events | Teriparatide (During 52 Weeks) | 115 | 136 |
| Total, other adverse events | Placebo (During 52 Weeks) | 59 | 67 |
| Total, other adverse events | Teriparatide (During 76 Weeks) | 123 | 136 |
| Total, other adverse events | Placebo (During 76 Weeks) | 60 | 67 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
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 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/NCT00433160
GET https://conductscience.org/api/trials/v1/NCT00433160/results?page=2