Trial · NCT00478569
Adherence to PTH(1-84) Treatment (FP-002-IM)
NCT00478569, Completed, Takeda; results first posted 2014-05-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adherence to PTH(1-84) Treatment (FP-002-IM). Trials, record NCT00478569. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00478569
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adherence to PTH(1-84) Treatment (FP-002-IM)
- NCT number
- NCT00478569
- Status
- Completed
- Enrollment
- 1,179 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Clinical Use of PTH(1-84)
- Interventions
- Parathyroid Hormone (PTH) (1-84)
- First posted
- 2007-05-25
- Last updated
- 2014-05-28
- Results first posted
- 2014-05-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Discontinued Before 6 Months of Treatment | 6 months | A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards. |
| Secondary | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | From enrollment to 3, 12, 18, and 24 months | A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards. A participant was defined as "temporarily discontinued" if treatment with PTH(1-84) was not ongoing at the time point but was then ongoing at a future time point. This was the case when a participant or investigator wanted to pause the treatment for a length of time (e.g. because of an adverse event or interruption). Therefore, a participant was defined as still "ongoing" during the trial if treatment with PTH(1-84) had not been permanently or temporarily discontinued at that time point. A participant was only defined as "missing" or "unknown" if they attended the relevant visit and there was no result or "unknown" was entered as the result. Results for months 3, 12, 18 and 24 are cumulative data up until that time point. |
| Secondary | Duration of Treatment | 24 months | Duration of treatment was defined as the last known date that PTH(1-84) was taken minus the first date that PTH(1-84) was taken plus one. In the calculation of duration, no adjustment was made for the prescribed dose frequency or for periods of temporary discontinuation due to adverse drug reactions (ADRs) or temporary patient suspension of treatment. |
| Secondary | Treatment Compliance by Visit | From enrollment to 3, 6, 12, 18, and 24 months | A participant was defined as compliant if the participant took the treatment as prescribed by the Physician, i.e. complied with the Physician's advice and followed the treatment regimen prescribed. A participant whose dose frequency and treatment length were changed during treatment, e.g. in response to a raised serum calcium level, was regarded as fully compliant if the revised treatment regimen was adhered to. Data on compliance were obtained at each visit and relate to the period since the previous recorded visit. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Discontinued Before 6 Months of Treatment | 6 months | All enrolled participants | participants | NUMBER |
| SECONDARY | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | From enrollment to 3, 12, 18, and 24 months | All enrolled participants | participants | NUMBER |
| SECONDARY | Duration of Treatment | 24 months | Participants for whom data were available | months | MEAN |
| SECONDARY | Treatment Compliance by Visit | From enrollment to 3, 6, 12, 18, and 24 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Discontinued Before 6 Months of Treatment | Parathyroid Hormone (PTH) (1-84) | 181 | participants | ||
| Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | 3 Months | Permanently discontinued | 75 | participants | |
| Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | 12 Months | Permanently discontinued | 198 | participants | |
| Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | 18 Months | Permanently discontinued | 284 | participants | |
| Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | 24 Months | Permanently discontinued | 525 | participants | |
| Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | 3 Months | Temporarily discontinued | 6 | participants | |
| Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | 12 Months | Temporarily discontinued | 8 | participants | |
| Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | 18 Months | Temporarily discontinued | 2 | participants | |
| Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | 24 Months | Temporarily discontinued | 2 | participants | |
| Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | 3 Months | Ongoing | 898 | participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Parathyroid Hormone (PTH) (1-84) | 1,170 | |
| Overall Study | COMPLETED | Parathyroid Hormone (PTH) (1-84) | 761 | |
| Overall Study | NOT COMPLETED | Parathyroid Hormone (PTH) (1-84) | 409 |
Source ClinicalTrials.gov
Adverse events100
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 | Palpitations | Cardiac disorders | Parathyroid Hormone (PTH) (1-84) | 5 | 1,170 | |
| other | Tachycardia | Cardiac disorders | Parathyroid Hormone (PTH) (1-84) | 5 | 1,170 | |
| other | Motion sickness | Ear and labyrinth disorders | Parathyroid Hormone (PTH) (1-84) | 3 | 1,170 | |
| other | Tinnitus | Ear and labyrinth disorders | Parathyroid Hormone (PTH) (1-84) | 1 | 1,170 | |
| other | Vertigo | Ear and labyrinth disorders | Parathyroid Hormone (PTH) (1-84) | 5 | 1,170 | |
| other | Hyperparathyroidism | Endocrine disorders | Parathyroid Hormone (PTH) (1-84) | 1 | 1,170 | |
| other | Panophthalmitis | Eye disorders | Parathyroid Hormone (PTH) (1-84) | 1 | 1,170 | |
| other | Visual impairment | Eye disorders | Parathyroid Hormone (PTH) (1-84) | 1 | 1,170 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Parathyroid Hormone (PTH) (1-84) | 3 | 1,170 | |
| other | Abdominal pain | Gastrointestinal disorders | Parathyroid Hormone (PTH) (1-84) | 1 | 1,170 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Parathyroid Hormone (PTH) (1-84) | ||
| Total, other adverse events | Parathyroid Hormone (PTH) (1-84) | 276 | 1,170 |
| Total, serious adverse events | Parathyroid Hormone (PTH) (1-84) | 10 | 1,170 |
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/NCT00478569
GET https://conductscience.org/api/trials/v1/NCT00478569/results?page=2