Compounds > alendronate
Page last updated: 2024-10-22

alendronate and HIV

alendronate has been researched along with HIV in 2 studies

alendronic acid : A 1,1-bis(phosphonic acid) that is methanebis(phosphonic acid) in which the two methylene hydrogens are replaced by hydroxy and 3-aminopropyl groups.

HIV: Human immunodeficiency virus. A non-taxonomic and historical term referring to any of two species, specifically HIV-1 and/or HIV-2. Prior to 1986, this was called human T-lymphotropic virus type III/lymphadenopathy-associated virus (HTLV-III/LAV). From 1986-1990, it was an official species called HIV. Since 1991, HIV was no longer considered an official species name; the two species were designated HIV-1 and HIV-2.

Research Excerpts

ExcerptRelevanceReference
"In this small study in children and adolescents perinatally infected with HIV with low LS BMD, 48 weeks of alendronate was well-tolerated, showed no safety concerns, and significantly improved LS and whole body BMD compared to participants on vitamin D/calcium supplementation and exercise alone."5.34Alendronate Improves Bone Mineral Density in Children and Adolescents Perinatally Infected With Human Immunodeficiency Virus With Low Bone Mineral Density for Age. ( Amaral, FR; Benson, J; Ferreira, F; Gaur, A; George, K; Gordon, C; Hazra, R; Jacobson, DL; Lindsey, JC; Pagano-Therrien, J; Siberry, GK; Spiegel, H, 2020)

Research

Studies (2)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's0 (0.00)24.3611
2020's2 (100.00)2.80

Authors

AuthorsStudies
Kalayjian, RC1
McComsey, GA1
Jacobson, DL1
Lindsey, JC1
Gordon, C1
Hazra, R1
Spiegel, H1
Ferreira, F1
Amaral, FR1
Pagano-Therrien, J1
Gaur, A1
George, K1
Benson, J1
Siberry, GK1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Impact of Oral Alendronate Therapy on Bone Mineral Density in HIV-infected Children and Adolescents With Low Bone Mineral Density[NCT00921557]Phase 252 participants (Actual)Interventional2009-11-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Percent Change From Baseline to Week 96 in Lumbar Spine BMD

Percent change was calculated as (measurement at week 96 - measurement at baseline)/measurement at baseline * 100%. Includes Groups 1A and 1B only. (NCT00921557)
Timeframe: Weeks 0 and 96

InterventionPercent change from baseline (Median)
1A: Alendronate/Alendronate24.9
1B: Alendronate/Placebo14.8

Percent Change From Baseline to Week 96 in Whole Body (With Head) BMD

Percent change was calculated as (measurement at week 96 - measurement at baseline)/measurement at baseline * 100%. Includes Groups 1A and 1B only. (NCT00921557)
Timeframe: Weeks 0 and 96

InterventionPercent change from baseline (Median)
1A: Alendronate/Alendronate19.6
1B: Alendronate/Placebo10.3

Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Lumbar Spine BMD

Percent change was calculated as (measurement at time T2 - measurement at time T1)/measurement at Time T1 * 100%. (NCT00921557)
Timeframe: Weeks 48, 96 and 144

InterventionPercent change (Median)
1B: Alendronate/Placebo (48 Week Change)0.9
2: Placebo/Alendronate (48 Week Change)2.0
1B: Alendronate/Placebo (96 Week Change)1.7

Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Whole Body (With Head) BMD

Percent change was calculated as (measurement at time T2 - measurement at time T2)/measurement at time T1 * 100%. (NCT00921557)
Timeframe: Weeks 48, 96 and 144

InterventionPercent change (Median)
1B: Alendronate/Placebo (48 Week Change)0.8
2: Placebo/Alendronate (48 Week Change)0.5
1B: Alendronate/Placebo (96 Week Change)0.9

Percentage of Participants Developing New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures

Signs, symptoms, and laboratory values were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 (December 2004). Results for Groups 1A and 1B were combined as both were on alendronate for the first 48 weeks. (NCT00921557)
Timeframe: Week 0 to 48

InterventionParticipants (Count of Participants)
1: Alendronate5
2: Placebo2

Change in CD4 Percent From Baseline

Change in percentage of lymphocytes that are CD4 cells calculated as measurement at each time point minus baseline measurement (NCT00921557)
Timeframe: Weeks 0, 48, 96 and 144

,,
Interventionpercent of lymphocytes that are CD4 cell (Median)
Week 48 - Week 0Week 96 - Week 0Week 144 - Week 0
1A: Alendronate/Alendronate001
1B: Alendronate/Placebo1-1-1
2: Placebo/Alendronate12-4

Change in Centers for Disease Control (CDC) HIV Disease Category

Percentage of participants advancing in CDC HIV disease category from baseline throughout study follow-up (NCT00921557)
Timeframe: Weeks 144

,,
InterventionParticipants (Count of Participants)
Week 0 to 48Week 48 to 96Week 96 to 144
1A: Alendronate/Alendronate100
1B: Alendronate/Placebo010
2: Placebo/Alendronate000

Effect of Other Known Bone Mineral Determinants (Age, Gender, Race/Ethnicity, Steroid Use, Depo-Provera, Tenofovir, Pubertal Stage, Bone Age, Vitamin D Status) and Inflammatory Cytokine Levels on Changes in Lumbar Spine BMD

A slope was fit for each participant to their percent change [(measurement at time T - measurement at baseline)/measurement at baseline)*100%] in lumbar spine BMD from baseline. Results represent average changes in lumbar spine BMD over one year. Results are summarized for age, gender, ethnicity, tenofovir use, Tanner stage, bone age and vitamin D level. Only one participant was on steroids and none were using Dep-Provera. Inflammatory cytokine levels were not assayed. Results were combined for Groups 1A and 1B as both were on alendronate for the first 48 weeks. (NCT00921557)
Timeframe: Weeks 0, 24 and 48

,
Interventionpercentage of baseline (Mean)
MaleFemaleNon-hispanicHispanic11 - < 15 years15 - < 19 years>= 19 yearsOn TenofovirNot on Tenofovir25-OH Vit D<30 ng/ml25-0H Vit D>=30 ng/mlBone age < 15 yearsBone age>=15 yearsTanner stage <= 3Tanner stage >= 4
1: Alendronate20.325.419.423.637.116.58.124.819.922.022.136.011.333.015.4
2: Placebo6.89.44.87.810.68.01.96.88.26.87.810.05.010.65.9

Effect of Other Known Bone Mineral Determinants (Age, Gender, Race/Ethnicity, Steroid Use, Depo-Provera, Tenofovir, Pubertal Stage, Bone Age, Vitamin D Status) and Inflammatory Cytokine Levels on Changes in Whole Body (With Head) BMD.

A slope was fit for each participant to their percent change [(measurement at time T - measurement at baseline)/measurement at baseline)*100%] in whole body (with head) BMD from baseline. Results represent average changes in whole body (with head) BMD over one year. Results are summarized for age, gender, ethnicity, tenofovir use, Tanner stage, bone age and vitamin D level. Only one participant was on steroids and none were using Dep-Provera. Inflammatory cytokine levels were not assayed. Results were combined for Groups 1A and 1B as both were on alendronate for the first 48 weeks. (NCT00921557)
Timeframe: Weeks 0, 24 and 48

,
Interventionpercentage of baseline (Mean)
MaleFemaleNon-HispanicHispanic11 - < 15 years15 - < 19 years>= 19 yearsOn tenofovirNot on tenofovir25-0H Vit D<30 ng/ml25-0H Vit D>=30 ng/mlBone age < 15 yearsBone age >=15 yearsTanner stage <= 3Tanner stage >= 4
1: Alendronate11.414.09.813.919.210.54.713.211.610.615.119.07.718.09.4
2: Placebo4.18.20.36.18.06.5-0.35.05.85.85.28.42.38.03.8

Percent Change From Baseline to Weeks 24 and 48 in Lumbar Spine BMD

Percent change was calculated as (measurement at time T - measurement at baseline)/measurement at baseline * 100%. Results for Groups 1A and 1B combined as both were on alendronate for the first 48 weeks. (NCT00921557)
Timeframe: Weeks 0, 24 and 48

,
InterventionPercent change from baseline (Median)
Week 24Week 48
1: Alendronate14.415.9
2: Placebo5.57.1

Percent Change From Baseline to Weeks 24 and 48 in Whole Body (With Head) BMD

Percent change was calculated as (measurement at time T - measurement at baseline)/measurement at baseline * 100%. Results for Groups 1A and 1B were combined as both were on alendronate for the first 48 weeks. (NCT00921557)
Timeframe: Weeks 0, 24 and 48

,
InterventionPercent change from baseline (Median)
Week 24Week 48
1: Alendronate5.510.7
2: Placebo0.35.2

Percent of Participants With HIV-1 RNA <= 400 Copies/ml

Percent calculated as number of participants with HIV-1 RNA <= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point. (NCT00921557)
Timeframe: Weeks 0, 48, 96 and 144

,,
InterventionParticipants (Count of Participants)
Week 0Week 48Week 96Week 144
1A: Alendronate/Alendronate10101210
1B: Alendronate/Placebo16161210
2: Placebo/Alendronate15141310

Safety as Measured by the Incidence of New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures

Signs, symptoms, and laboratory values were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 (December 2004). (NCT00921557)
Timeframe: Weeks 0 to 144

,,
InterventionParticipants (Count of Participants)
Week 0 to 48Week 48 to 96Week 96 to 144
1A: Alendronate/Alendronate213
1B: Alendronate/Placebo334
2: Placebo/Alendronate223

Trials

1 trial available for alendronate and HIV

ArticleYear
Alendronate Improves Bone Mineral Density in Children and Adolescents Perinatally Infected With Human Immunodeficiency Virus With Low Bone Mineral Density for Age.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 08-22, Volume: 71, Issue:5

    Topics: Adolescent; Adult; Alendronate; Bone Density; Bone Density Conservation Agents; Bone Diseases, Metab

2020

Other Studies

1 other study available for alendronate and HIV

ArticleYear
Bisphosphonates in Perinatally Infected Children and Adolescents With Human Immunodeficiency Virus: Targeting Puberty.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 08-22, Volume: 71, Issue:5

    Topics: Adolescent; Alendronate; Bone Density; Bone Diseases, Metabolic; Child; Diphosphonates; HIV; HIV Inf

2020