Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061256
Status:
COMPLETED
Last Update Posted:
2009-08-07
First Post:
2003-05-22
Brief Title:
The Effect of Alendronate Calcium and Vitamin D on Bone Mineral Density in HIV Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Randomized Double-Blind Placebo-Controlled Study of Once-Weekly Alendronate in HIV-Infected Subjects With Decreased Bone Mineral Density Receiving Calcium and Vitamin D
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
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:
Alendronate is a drug that is used to treat osteoporosis The purpose of this study is to examine whether alendronate in combination with calcium and vitamin D is safe and effective for treating bone loss in people with HIV
Detailed Description:
Decreased bone mineral density BMD has been identified in up to 50 of HIV infected men with severe osteoporosis in up to 21 of these men The mechanisms underlying these bone abnormalities remain unclear Bisphosphonates are potent bone resorption inhibitors and have been shown to be effective in treating osteoporosis While several bisphosphonates are approved for the treatment of osteoporosis in women alendronate is the only bisphosphonate approved for treatment in men This study hypothesizes that alendronate will be able to reverse decreased BMD secondary to inhibition of bone resorption in HIV infected patients treated with potent antiretroviral therapy and that these patients will be able to tolerate alendronate without any significant toxicities The study will also examine the efficacy of once-weekly alendronate with daily calcium and vitamin D in both men and women with HIV
Patients will participate in this study for 48 weeks Patients will be randomly assigned to receive either alendronate or placebo All patients will receive calcium and vitamin D Dual energy x-ray absorptiometry DEXA scans will be used to evaluate bone density at each visit After study entry patients will have visits at Weeks 2 12 24 36 and 48 During these visits blood will be drawn and a pregnancy test may be performed Patients must fast for at least 8 hours prior to the entry visit and for the visits at Weeks 2 12 24 and 48
Patients will participate in this study for 48 weeks Patients will be randomly assigned to receive either alendronate or placebo All patients will receive calcium and vitamin D Dual energy x-ray absorptiometry DEXA scans will be used to evaluate bone density at each visit After study entry patients will have visits at Weeks 2 12 24 36 and 48 During these visits blood will be drawn and a pregnancy test may be performed Patients must fast for at least 8 hours prior to the entry visit and for the visits at Weeks 2 12 24 and 48
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 |
|---|---|---|---|
| DAIDS-ES ID 10089 | None | None | None |