Trial · NCT01430104
A Study of Teriparatide in Japanese Osteoporosis Patients
NCT01430104, Phase 4, Completed, Eli Lilly and Company; results first posted 2012-12-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Teriparatide in Japanese Osteoporosis Patients. Trials, record NCT01430104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01430104
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Teriparatide in Japanese Osteoporosis Patients
- NCT number
- NCT01430104
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 30 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Osteoporosis
- Interventions
- Teriparatide, Aspara-CA 600 mg, Alfarol 1.0 µg
- First posted
- 2011-09-07
- Last updated
- 2013-01-14
- Results first posted
- 2012-12-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) | Day 28 (16 and 24 hours postdose) | Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \[g/dL\]). Postdose refers to after Teriparatide dose. |
| Secondary | Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline | Day 1 up to Day 28 (Teriparatide Treatment Period) | Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \[g/dL\]). Serum calcium levels presented are for any time postdose on any day during the 28-day Teriparatide Treatment Period. |
| Secondary | Mean Serum Calcium Levels | Baseline (Day -1 of 14-day Lead-in Period) and Day 1 and Day 7 and Day 14 and Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period) | Daily profiles of corrected mean serum calcium levels were determined for each participant. Corrected calcium (milligram per deciliter \[mg/dL\]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \[g/dL\]). The Least Squares (LS) means were adjusted for Day, Timepoint, Day\*Timepoint, and random error. At baseline, participants received only Aspara-CA and Alfarol supplements and the timepoints were based on the times before Aspara-CA and Alfarol administration (predose) and after Aspara-CA and Alfarol administration (postdose). During the 28-day Teriparatide Treatment Period, timepoints were based on before Teriparatide administration (predose) and after Teriparatide administration (postdose). |
| Secondary | Change From Baseline in Serum Calcium | Baseline (Day -1 of the 14-day Lead-in Period), Day 1, Day 7, Day 14, Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period) | Corrected calcium (milligram per deciliter \[mg/dL\]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \[g/dL\]). The Least Squares (LS) means were controlled for Day, Timepoint, Day\*Timepoint, and random error. Postdose refers to after Teriparatide dose. |
| Secondary | Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline | Day 1 up to Day 28 (28-day Teriparatide Treatment Period) | Urine calcium levels presented are for any day during the 28-day Teriparatide Treatment Period. |
| Secondary | Mean Daily Urine Calcium Excreted | Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period) | |
| Secondary | Change From Baseline in Daily Urine Calcium Excreted | Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period) | |
| Secondary | Concentrations of Serum 25-Hydroxy-Vitamin D | Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period) | |
| Secondary | Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3 | Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period) |
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 | Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) | Day 28 (16 and 24 hours postdose) | All enrolled participants who received at least 1 dose of Teriparatide and had either a 16-hour or 24-hour postdose serum calcium assessment on Day 28 were included in the analysis. | participants | NUMBER |
| SECONDARY | Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline | Day 1 up to Day 28 (Teriparatide Treatment Period) | All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum calcium assessment were included in the analysis. | participants | NUMBER |
| SECONDARY | Mean Serum Calcium Levels | Baseline (Day -1 of 14-day Lead-in Period) and Day 1 and Day 7 and Day 14 and Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period) | All enrolled participants who received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Serum Calcium | Baseline (Day -1 of the 14-day Lead-in Period), Day 1, Day 7, Day 14, Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period) | All enrolled participants who complied received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline | Day 1 up to Day 28 (28-day Teriparatide Treatment Period) | All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis. | participants | NUMBER |
| SECONDARY | Mean Daily Urine Calcium Excreted | Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period) | All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis. | grams per day (g/day) | MEAN |
| SECONDARY | Change From Baseline in Daily Urine Calcium Excreted | Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period) | All enrolled participants who received at least 1 dose of Teriparatide, had a baseline urine calcium assessment, and at least 1 postdose urine calcium assessment were included in the analysis. | grams per day (g/day) | MEAN |
| SECONDARY | Concentrations of Serum 25-Hydroxy-Vitamin D | Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period) | All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 25-Hydroxy-Vitamin D assessment were included in the analysis. | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3 | Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period) | All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 1,25-Hydroxy-Vitamin D3 assessment were included in the analysis. | picogram per milliliter (pg/mL) | MEAN |
Source ClinicalTrials.gov
Results by group77
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 16 hours postdose | 0 | 0 | participants |
| Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 24 hours postdose | 0 | participants | |
| Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Serum Calcium > 11.0 mg/dL | 0 | participants | |
| Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Serum Calcium > 13.5 mg/dL | 0 | participants | |
| Mean Serum Calcium Levels | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Baseline: 0 h predose | 9.00 | 90% Confidence Interval 8.92 to 9.07 | mg/dL |
| Mean Serum Calcium Levels | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Baseline: 2 h postdose | 9.11 | 90% Confidence Interval 9.03 to 9.19 | mg/dL |
| Mean Serum Calcium Levels | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Baseline: 4 h postdose | 8.98 | 90% Confidence Interval 8.91 to 9.05 | mg/dL |
| Mean Serum Calcium Levels | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Baseline: 6 h postdose | 8.92 | 90% Confidence Interval 8.86 to 8.98 | mg/dL |
| Mean Serum Calcium Levels | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Baseline: 16 h postdose | 8.97 | 90% Confidence Interval 8.90 to 9.03 | mg/dL |
| Mean Serum Calcium Levels | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | Baseline: 24 h postdose | 8.74 | 90% Confidence Interval 8.67 to 8.81 | mg/dL |
1 to 10 of 77Source ClinicalTrials.gov
See all 77 results by groupParticipant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 14-Day Lead-In Period | STARTED | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 30 | |
| 14-Day Lead-In Period | COMPLETED | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 30 | |
| 14-Day Lead-In Period | NOT COMPLETED | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 0 | |
| 28-Day Teriparatide Treatment Period | STARTED | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 29 | |
| 28-Day Teriparatide Treatment Period | Received at Least 1 Dose of Teriparatide | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 29 | |
| 28-Day Teriparatide Treatment Period | COMPLETED | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 28 | |
| 28-Day Teriparatide Treatment Period | NOT COMPLETED | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 1 |
Source ClinicalTrials.gov
Adverse events7
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 | Vertigo positional | Ear and labyrinth disorders | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 1 | 29 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 1 | 29 | 1 |
| other | Cystitis | Infections and infestations | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 1 | 29 | 1 |
| other | Nasopharyngitis | Infections and infestations | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 1 | 29 | 1 |
| other | Back pain | Musculoskeletal and connective tissue disorders | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 1 | 29 | 1 |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 1 | 29 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 1 | 29 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | ||
| Total, other adverse events | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 5 | 29 |
| Total, serious adverse events | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 0 | 29 |
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/NCT01430104
GET https://conductscience.org/api/trials/v1/NCT01430104/results?page=2