Trial · NCT00879034
A Study of Zoledronic Acid, Pravastatin, and Lonafarnib for Patients With Progeria
NCT00879034, Phase 2, Completed, Boston Children's Hospital; results first posted 2017-07-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Zoledronic Acid, Pravastatin, and Lonafarnib for Patients With Progeria. Trials, record NCT00879034. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00879034
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Zoledronic Acid, Pravastatin, and Lonafarnib for Patients With Progeria
- NCT number
- NCT00879034
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Boston Children's Hospital
- Conditions
- Progeria, Hutchinson-Gilford Syndrome
- Interventions
- Lonafarnib, Zoledronic Acid, Pravastatin
- First posted
- 2009-04-09
- Last updated
- 2019-06-13
- Results first posted
- 2017-07-31
- Limitations and caveats
This was an open label clinical trial on a very rare disease population. Patient numbers are small, though 5 participants represents a small but significant portion of the world's population of children with HGPS.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Objective of This Study is to Evaluate the Feasibility of Administering Intravenous Zoledronic Acid, Oral Pravastatin and Oral Lonafarnib, to Patients With Progeria for a Minimum of 4 Weeks | 4 weeks | Feasibility was assessed by determining the number of participants with adverse events occurring over the course of the 4 week study. |
| Secondary | To Describe Any Acute and Chronic Toxicities Associated With Treating Progeria Patients With the Combination of Zoledronic Acid, Pravastatin and Lonafarnib | 4 weeks | Number of participants with acute and chronic toxicities associated with treating progeria patients with the combination of zoledronic acid, pravastatin and lonafarnib |
| Secondary | To Investigate Which Clinical and Laboratory Studies Are Needed to Monitor or Alter Therapy to Prevent Unacceptable Toxicity | 4 weeks | The number of participants with abnormal CBC w/diff panel, LFTs, renal functions and lipid panels. |
| Secondary | To Assess the Pharmacokinetics of Lonafarnib in Patients With Progeria. | 4 weeks | |
| Secondary | To Assay for the Inhibition of HDJ-2 Farnesylation in Peripheral Blood Leukocytes (PBL) | 4 weeks | |
| Secondary | To Obtain Baseline Clinical and Laboratory Data so That Longer-term Measures of Efficacy Will be Achievable if Treatment Continues Beyond the 4-week Feasibility Study Period. | 4 weeks | The number of participants from whom baseline clinical and Laboratory data was obtained. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Objective of This Study is to Evaluate the Feasibility of Administering Intravenous Zoledronic Acid, Oral Pravastatin and Oral Lonafarnib, to Patients With Progeria for a Minimum of 4 Weeks | 4 weeks | Results are reported for the 5 patients who completed the 4 weeks of therapy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | To Describe Any Acute and Chronic Toxicities Associated With Treating Progeria Patients With the Combination of Zoledronic Acid, Pravastatin and Lonafarnib | 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | To Investigate Which Clinical and Laboratory Studies Are Needed to Monitor or Alter Therapy to Prevent Unacceptable Toxicity | 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | To Assess the Pharmacokinetics of Lonafarnib in Patients With Progeria. | 4 weeks | This data was not collected for this feasibility study. Pharmacokinetics assessment of lonafarnib in these 5 patients was analyzed at the end of a different protocol, NCT00916747. | ||
| SECONDARY | To Assay for the Inhibition of HDJ-2 Farnesylation in Peripheral Blood Leukocytes (PBL) | 4 weeks | This data was not collected for this feasibility study. HDJ-2 assessment in these 5 patients was analyzed at the end of a different protocol, NCT00916747. | ||
| SECONDARY | To Obtain Baseline Clinical and Laboratory Data so That Longer-term Measures of Efficacy Will be Achievable if Treatment Continues Beyond the 4-week Feasibility Study Period. | 4 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
The Primary Objective of This Study is to Evaluate the Feasibility of Administering Intravenous Zoledronic Acid, Oral Pravastatin and Oral Lonafarnib, to Patients With Progeria for a Minimum of 4 Weeks | Zoledronic Acid, Pravastatin, and Lonafarnib | 0 | Participants | ||
| To Describe Any Acute and Chronic Toxicities Associated With Treating Progeria Patients With the Combination of Zoledronic Acid, Pravastatin and Lonafarnib | Zoledronic Acid, Pravastatin, and Lonafarnib | 0 | Participants | ||
| To Investigate Which Clinical and Laboratory Studies Are Needed to Monitor or Alter Therapy to Prevent Unacceptable Toxicity | Zoledronic Acid, Pravastatin, and Lonafarnib | 0 | Participants | ||
| To Obtain Baseline Clinical and Laboratory Data so That Longer-term Measures of Efficacy Will be Achievable if Treatment Continues Beyond the 4-week Feasibility Study Period. | Zoledronic Acid, Pravastatin, and Lonafarnib | 5 | Participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zoledronic Acid, Pravastatin, and Lonafarnib | 5 | |
| Overall Study | Received Treatment | Zoledronic Acid, Pravastatin, and Lonafarnib | 4 | |
| Overall Study | COMPLETED | Zoledronic Acid, Pravastatin, and Lonafarnib | 5 | |
| Overall Study | NOT COMPLETED | Zoledronic Acid, Pravastatin, and Lonafarnib | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zoledronic Acid, Pravastatin, and Lonafarnib | 0 | 5 |
| Total, other adverse events | Zoledronic Acid, Pravastatin, and Lonafarnib | 0 | 5 |
| Total, serious adverse events | Zoledronic Acid, Pravastatin, and Lonafarnib | 0 | 5 |
Source ClinicalTrials.gov
Papers4
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/NCT00879034
GET https://conductscience.org/api/trials/v1/NCT00879034/registered