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Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents

Primary Purpose

HIV Infection

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Alendronate

Placebo

Calcium carbonate/vitamin D

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring Bone mineral density

Eligibility Criteria

11 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (Version 2.0 of protocol):

Documentation of HIV-1 infection
HIV-infection acquired before puberty
For participants receiving antiretroviral therapy, must have been on the same antiretroviral agents for at least 12 weeks prior to study entry and have a viral load less than 10,000 copies/mL. For participants not receiving antiretroviral therapy, must have not been on antiretroviral agents for at least 12 weeks prior to study entry and have no indication for therapy
Lumbar spine DXA BMD z-score less than -1.5 or history of fragility fracture within the prior 12 months (regardless of DXA result).
Available for routine dental exam and care every 6 months
Demonstrated ability and willingness to swallow study medications
Females of reproductive potential must have had a negative pregnancy test at screening and within 48 hours prior to study entry. They must also have agreed to avoid pregnancy while on the study and if engaging in sexual activity, use at least two forms of contraception.
Parent or legal guardian able and willing to provide signed informed consent for children who could not provide consent for themselves.

Exclusion Criteria (Version 2.0 of protocol):

Body weight more than 300 lbs.
For female participants: if on Depo-Provera, they must have been on it for at least 1 year prior to study entry; if not on Depa-Provera, they must have not been on it for at least 1 year prior to study entry.
Anticonvulsant therapy
Proven growth hormone deficiency
Use of growth hormone in the 12 months prior to entry
Primary hyperparathyroidism
Hypoparathyroidism
Renal failure
Cushing syndrome
Active dental infection
Dental or periodontal disease expected to require more than basic restorative care
Pregnancy or lactation
Esophageal or gastric ulcer, chronic nonsteroidal anti-inflammatory drug (NSAID) use, or aspirin use
Tenofovir disoproxil fumarate (TDF): if on TDF, they must have been on it for at least 6 months prior to study entry; if not on TDF, they must have not been on it for at least 6 months prior to study entry.
Hemoglobin less than 10 g/dL
Any past pharmacologic treatment (except vitamin D and/or calcium supplementation) for low bone density
Inability to stand or sit upright for at least 30 minutes
Hypersensitivity to any component of alendronate
Hypocalcemia (less than the lower limit of normal established by the local laboratory in which it was performed)
Known abnormalities of the esophagus that delay esophageal emptying such as stricture or achalasia
25-OH vitamin D less than 10 ng/mL in combination with elevated intact PTH above the upper limit of normal for the local laboratory in which it was performed

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

1A: Alendronate/Alendronate

1B: Alendronate/Placebo

2: Placebo/Alendronate

Arm Description

Participants received alendronate for 96 weeks and calcium carbonate/vitamin D for 144 weeks

Participants received alendronate for 48 weeks followed by placebo for 48 weeks and calcium carbonate/vitamin D for 144 weeks

Participants received placebo for 48 weeks followed by alendronate for 48 weeks and calcium carbonate/vitamin D for 144 weeks

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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).

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.

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.

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%.

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%.

Change From Baseline to Week 48 in Bone Marker Turnover

Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.

Correlation of Changes in Bone Marker Turnover With Changes in Lumbar Spine and Whole Body (With Head) BMD

Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.

Change From Baseline to Week 48 in Receptor Activator of Nuclear Factor Kappa-B Ligand/Osteoprotegerin (RANKL/OPG) Ratio

Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.

Correlation of Changes in RANKL/OPG Ratio With Changes in Lumbar Spine and Whole Body (With Head) BMD

Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.

Change From Baseline to Week 48 in Central Fat Content

Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.

Correlation of Changes in Central Fat Content With Changes in Lumbar Spine and Whole Body (With Head) BMD

Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.

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.

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

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

Percent of Participants With Detectable Urinary Alendronate

Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.

Full Information

NCT ID

NCT00921557

First Posted

June 12, 2009

Last Updated

November 3, 2021

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT00921557

Brief Title

Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents

Official Title

Impact of Oral Alendronate Therapy on Bone Mineral Density in HIV-infected Children and Adolescents With Low Bone Mineral Density

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

November 2009 (Actual)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

HIV-infected children, youth, and adults have lower bone mineral density (BMD) than would be expected for HIV-uninfected people of similar age, weight and race. As the majority of perinatally HIV-infected U.S. children are entering or in adolescence, the potential for HIV-related impaired BMD during the adolescent peak of bone mass acquisition is of particular concern. The primary purpose of this study was to compare changes from pre-treatment levels of BMD of the lumbar spine after 24 and 48 weeks of alendronate treatment with placebo in HIV-infected children and adolescents.

Detailed Description

Puberty is a time when the foundation is laid for healthy bone mass. Over the course of puberty, 26% of bone mass is established in the 4-year period of peak height velocity and up to 60% of adult peak bone mass is established. Factors that affect normal bone mineralization include calcium intake, vitamin D status, degree of physical and weight bearing activities, hormones, genetics, body weight, and general health and nutrition status. HIV-infected children, youth, and adults have lower bone mineral density (BMD) than would be expected for healthy people of similar age, weight, and race. As the majority of perinatally HIV-infected U.S. children are entering or in adolescence, the potential for HIV-related impaired BMD during the adolescent peak of bone mass acquisition is of particular concern. The purpose of this study was to compare changes in BMD of the lumbar spine from pre-treatment levels to 24 and 48 weeks after alendronate treatment or placebo in HIV-infected children and adolescents. Participants were randomized equally into one of three groups: Group 1A received alendronate for 96 weeks; Group 1B received alendronate for 48 weeks followed by placebo for 48 weeks; Group 2 received placebo for 48 weeks followed by alendronate for 48 weeks. All three groups were followed off treatment for an additional 48 weeks. Participants also received vitamin D/calcium for the duration of the study and were asked to perform 60 minutes of weight-bearing exercise each day. Clinic visits were scheduled every 12 weeks after entry, with telephone contact visits one, four, and 28 weeks after entry and the week 48 visit. A physical exam and dental assessment was conducted at each clinic visit, and a history of adverse events collected. Dual Energy X-ray absorptiometry (DXA), hematology and chemistry panels were conducted at entry and weeks 24, 48, 72, 96 and 144. Lumbar spine and whole body (with head) BMD was measured using Hologic DXA scanners (QDR4500A, QDR4500W or Delphi A models). The primary analysis compared changes from entry to 24 and 48 weeks in lumbar spine BMD between Groups 1A and 1B combined (both on alendronate for initial 48 weeks) vs. Group 2 (on placebo for 48 weeks). Study participants were unblinded after 96 weeks of follow-up (the primary completion date) but remained on study, off study treatment, for an additional 48 weeks. Secondary laboratory outcomes listed in the protocol (bone marker turnover and Receptor Activator of Nuclear Factor Kappa-B Ligand/Osteoprotegerin (RANKL/OPG) Ratio) and central fat content, which required application for additional funding for laboratory testing, will not be performed and no results will be available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infection

Keywords

Bone mineral density

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1A: Alendronate/Alendronate

Arm Type

Experimental

Arm Description

Participants received alendronate for 96 weeks and calcium carbonate/vitamin D for 144 weeks

Arm Title

1B: Alendronate/Placebo

Arm Type

Experimental

Arm Description

Participants received alendronate for 48 weeks followed by placebo for 48 weeks and calcium carbonate/vitamin D for 144 weeks

Arm Title

2: Placebo/Alendronate

Arm Type

Experimental

Arm Description

Participants received placebo for 48 weeks followed by alendronate for 48 weeks and calcium carbonate/vitamin D for 144 weeks

Intervention Type

Drug

Intervention Name(s)

Alendronate

Other Intervention Name(s)

Fosamax

Intervention Description

Oral tablet taken once weekly: 70 mg if participant greater than 30 kg or 35 mg if participant less than or equal to 30 kg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral tablet taken once weekly

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcium carbonate/vitamin D

Intervention Description

Tablet taken once or twice daily: calcium carbonate (600 mg) and vitamin D (400 IU) once daily for participants with 25-OH-vitamin D levels greater than or equal to 20 ng/mL or twice daily for those with 25-OH-vitamin D levels less than 20 ng/mL

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Weeks 0, 24 and 48

Title

Description

Time Frame

Week 0 to 48

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Weeks 0, 24 and 48

Title

Percent Change From Baseline to Week 96 in Lumbar Spine BMD

Description

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

Time Frame

Weeks 0 and 96

Title

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

Description

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

Time Frame

Weeks 0 and 96

Title

Description

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).

Time Frame

Weeks 0 to 144

Title

Description

Time Frame

Weeks 0, 24 and 48

Title

Description

Time Frame

Weeks 0, 24 and 48

Title

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

Description

Percent change was calculated as (measurement at time T2 - measurement at time T1)/measurement at Time T1 * 100%.

Time Frame

Weeks 48, 96 and 144

Title

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

Description

Percent change was calculated as (measurement at time T2 - measurement at time T2)/measurement at time T1 * 100%.

Time Frame

Weeks 48, 96 and 144

Title

Change From Baseline to Week 48 in Bone Marker Turnover

Description

Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.

Time Frame

Weeks 0 and 48

Title

Correlation of Changes in Bone Marker Turnover With Changes in Lumbar Spine and Whole Body (With Head) BMD

Description

Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.

Time Frame

Weeks 0 and 48

Title

Change From Baseline to Week 48 in Receptor Activator of Nuclear Factor Kappa-B Ligand/Osteoprotegerin (RANKL/OPG) Ratio

Description

Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.

Time Frame

Weeks 0 and 48

Title

Correlation of Changes in RANKL/OPG Ratio With Changes in Lumbar Spine and Whole Body (With Head) BMD

Description

Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.

Time Frame

Weeks 0 and 48

Title

Change From Baseline to Week 48 in Central Fat Content

Description

Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.

Time Frame

Weeks 0 and 48

Title

Correlation of Changes in Central Fat Content With Changes in Lumbar Spine and Whole Body (With Head) BMD

Description

Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.

Time Frame

Weeks 0 and 48

Title

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

Description

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.

Time Frame

Weeks 0, 48, 96 and 144

Title

Change in CD4 Percent From Baseline

Description

Change in percentage of lymphocytes that are CD4 cells calculated as measurement at each time point minus baseline measurement

Time Frame

Weeks 0, 48, 96 and 144

Title

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

Description

Percentage of participants advancing in CDC HIV disease category from baseline throughout study follow-up

Time Frame

Weeks 144

Title

Percent of Participants With Detectable Urinary Alendronate

Description

Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.

Time Frame

Weeks 48, 96 and 144

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria (Version 2.0 of protocol): Documentation of HIV-1 infection HIV-infection acquired before puberty For participants receiving antiretroviral therapy, must have been on the same antiretroviral agents for at least 12 weeks prior to study entry and have a viral load less than 10,000 copies/mL. For participants not receiving antiretroviral therapy, must have not been on antiretroviral agents for at least 12 weeks prior to study entry and have no indication for therapy Lumbar spine DXA BMD z-score less than -1.5 or history of fragility fracture within the prior 12 months (regardless of DXA result). Available for routine dental exam and care every 6 months Demonstrated ability and willingness to swallow study medications Females of reproductive potential must have had a negative pregnancy test at screening and within 48 hours prior to study entry. They must also have agreed to avoid pregnancy while on the study and if engaging in sexual activity, use at least two forms of contraception. Parent or legal guardian able and willing to provide signed informed consent for children who could not provide consent for themselves. Exclusion Criteria (Version 2.0 of protocol): Body weight more than 300 lbs. For female participants: if on Depo-Provera, they must have been on it for at least 1 year prior to study entry; if not on Depa-Provera, they must have not been on it for at least 1 year prior to study entry. Anticonvulsant therapy Proven growth hormone deficiency Use of growth hormone in the 12 months prior to entry Primary hyperparathyroidism Hypoparathyroidism Renal failure Cushing syndrome Active dental infection Dental or periodontal disease expected to require more than basic restorative care Pregnancy or lactation Esophageal or gastric ulcer, chronic nonsteroidal anti-inflammatory drug (NSAID) use, or aspirin use Tenofovir disoproxil fumarate (TDF): if on TDF, they must have been on it for at least 6 months prior to study entry; if not on TDF, they must have not been on it for at least 6 months prior to study entry. Hemoglobin less than 10 g/dL Any past pharmacologic treatment (except vitamin D and/or calcium supplementation) for low bone density Inability to stand or sit upright for at least 30 minutes Hypersensitivity to any component of alendronate Hypocalcemia (less than the lower limit of normal established by the local laboratory in which it was performed) Known abnormalities of the esophagus that delay esophageal emptying such as stricture or achalasia 25-OH vitamin D less than 10 ng/mL in combination with elevated intact PTH above the upper limit of normal for the local laboratory in which it was performed

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George K. Siberry, MD

Organizational Affiliation

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Official's Role

Study Chair

Facility Information:

Facility Name

David Geffen School of Medicine at UCLA NICHD CRS

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-1752

Country

United States

Facility Name

Pediatric Perinatal HIV Clinical Trials Unit CRS

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

USF - Tampa NICHD CRS

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Lurie Children's Hospital of Chicago (LCH) CRS

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60614-3393

Country

United States

Facility Name

Johns Hopkins Univ. Baltimore NICHD CRS

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

WNE Maternal Pediatric Adolescent AIDS CRS

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

St. Jude Children's Research Hospital CRS

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105

Country

United States

Facility Name

SOM Federal University Minas Gerais Brazil NICHD CRS

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30130-100

Country

Brazil

Facility Name

Univ. of Sao Paulo Brazil NICHD CRS

City

Sao Paulo

ZIP/Postal Code

14049-900

Country

Brazil

Facility Name

San Juan City Hosp. PR NICHD CRS

City

San Juan

ZIP/Postal Code

00936

Country

Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

18413693

Citation

Clay PG, Voss LE, Williams C, Daume EC. Valid treatment options for osteoporosis and osteopenia in HIV-infected persons. Ann Pharmacother. 2008 May;42(5):670-9. doi: 10.1345/aph.1K465. Epub 2008 Apr 15.

Results Reference

background

PubMed Identifier

18025884

Citation

McComsey GA, Kendall MA, Tebas P, Swindells S, Hogg E, Alston-Smith B, Suckow C, Gopalakrishnan G, Benson C, Wohl DA. Alendronate with calcium and vitamin D supplementation is safe and effective for the treatment of decreased bone mineral density in HIV. AIDS. 2007 Nov 30;21(18):2473-82. doi: 10.1097/QAD.0b013e3282ef961d.

Results Reference

background

PubMed Identifier

19487264

Citation

Stoch SA, Saag KG, Greenwald M, Sebba AI, Cohen S, Verbruggen N, Giezek H, West J, Schnitzer TJ. Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial. J Rheumatol. 2009 Aug;36(8):1705-14. doi: 10.3899/jrheum.081207. Epub 2009 Jun 1.

Results Reference

background

Citation

The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009).

Results Reference

background

PubMed Identifier

31573608

Citation

Jacobson DL, Lindsey JC, Gordon C, Hazra R, Spiegel H, Ferreira F, Amaral FR, Pagano-Therrien J, Gaur A, George K, Benson J, Siberry GK. Alendronate Improves Bone Mineral Density in Children and Adolescents Perinatally Infected With Human Immunodeficiency Virus With Low Bone Mineral Density for Age. Clin Infect Dis. 2020 Aug 22;71(5):1281-1288. doi: 10.1093/cid/ciz957.

Results Reference

derived

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Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents

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Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents

HIV Infection

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial