Treatment of the Hutchinson-Gilford Progeria Syndrome With a Combination of Pravastatin and Zoledronic Acid
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ClinicalTrials.gov Identifier: NCT00731016 |
Recruitment Status
:
Completed
First Posted
: August 8, 2008
Last Update Posted
: July 8, 2013
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Sponsor:
Assistance Publique Hopitaux De Marseille
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
Tracking Information | ||||
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First Submitted Date ICMJE | August 1, 2008 | |||
First Posted Date ICMJE | August 8, 2008 | |||
Last Update Posted Date | July 8, 2013 | |||
Study Start Date ICMJE | October 2008 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
To evaluate the tolerance and efficacy of pravastatin and zoledronic acid in combination on the patient's weight, height and bone metabolism in Progeria treatment [ Time Frame: 48 months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00731016 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
To evaluate the tolerance and efficacy of the treatment on other clinical and biological symptoms [ Time Frame: 48 months ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Treatment of the Hutchinson-Gilford Progeria Syndrome With a Combination of Pravastatin and Zoledronic Acid | |||
Official Title ICMJE | Treatment of the Hutchinson-Gilford Progeria Syndrome With a Combination of Pravastatin and Zoledronic Acid | |||
Brief Summary | We suggest treating the Hutchinson-Gilford Progeria Syndrome by two molecules (zoledronic acid and pravastatin).The therapeutic approach which we propose has for objectives to reduce, to prevent or to delay the gravest infringements of the disease, to prolong the life of the children, and in a more general way, aim at improving their living conditions. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hutchinson-Gilford Progeria Syndrome | |||
Intervention ICMJE | Drug: Zoledronic acid, pravastatin
Pravastatin : 10 mg daily Zoledronic acid : slow (30 mn) intravenous injections, diluted into 50 ml of saline solution following this schedule :
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Study Arms | 1
Zoledronic acid, pravastatin
Intervention: Drug: Zoledronic acid, pravastatin |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
15 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | July 2013 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 3 Years and older (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00731016 | |||
Other Study ID Numbers ICMJE | 2008-002471-27 2008-15 |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Assistance Publique Hopitaux De Marseille | |||
Study Sponsor ICMJE | Assistance Publique Hopitaux De Marseille | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Assistance Publique Hopitaux De Marseille | |||
Verification Date | July 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |