Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102908
Status:
UNKNOWN
Last Update Posted:
2008-09-26
First Post:
2005-02-04
Brief Title:
Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Bisphosphonate Therapy for HIV-Associated Osteopenia
Status:
UNKNOWN
Status Verified Date:
2008-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bisphosphonates are a type of drug used to prevent and treat bone loss The purpose of this study is to determine if zoledronate an investigational bisphosphonate can improve bone mineral density BMD in HIV-infected adults
Study hypothesis Zoledronate will reduce bone resorption in HIV-infected persons with osteopenia
Study hypothesis Zoledronate will reduce bone resorption in HIV-infected persons with osteopenia
Detailed Description:
Decreased BMD and bone loss is estimated to affect up to 675 of the HIV-infected population HIV-associated bone loss may be a result of antiretroviral treatment ART but can also be caused by the infection itself To date treatment for this bone loss has not been established Before prescribing drugs to treat bone loss physicians must take into account patients already demanding ART schedules and potential nonadherence This study will evaluate the efficacy of a single IV dose of zoledronate an investigational bisphosphonate in treating HIV-associated bone loss
This study will last 1 year Participants will be randomly assigned to receive zoledronate or placebo at study entry their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis There will be 7 study visits at screening study entry Week 2 and Months 3 6 9 and 12 Blood collection will occur at all visits Medical history a physical exam a dual-energy x-ray absorptiometry DEXA scan to measure bone density and a nutrition evaluation will occur at selected visits
This study will last 1 year Participants will be randomly assigned to receive zoledronate or placebo at study entry their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis There will be 7 study visits at screening study entry Week 2 and Months 3 6 9 and 12 Blood collection will occur at all visits Medical history a physical exam a dual-energy x-ray absorptiometry DEXA scan to measure bone density and a nutrition evaluation will occur at selected visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21AI058756-01 | NIH | None | httpsreporternihgovquickSearch1R21AI058756-01 |