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
Sponsored by

About this trial
This is an interventional treatment trial for HIV Infection focused on measuring Bone mineral density
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
Sites / Locations
- David Geffen School of Medicine at UCLA NICHD CRS
- Pediatric Perinatal HIV Clinical Trials Unit CRS
- USF - Tampa NICHD CRS
- Lurie Children's Hospital of Chicago (LCH) CRS
- Johns Hopkins Univ. Baltimore NICHD CRS
- WNE Maternal Pediatric Adolescent AIDS CRS
- St. Jude Children's Research Hospital CRS
- SOM Federal University Minas Gerais Brazil NICHD CRS
- Univ. of Sao Paulo Brazil NICHD CRS
- San Juan City Hosp. PR NICHD CRS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
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.
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.
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
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.
Time Frame
Weeks 0, 24 and 48
Title
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
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). Results for Groups 1A and 1B were combined as both were on alendronate for the first 48 weeks.
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
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.
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
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
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
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
Description
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.
Time Frame
Weeks 0, 24 and 48
Title
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.
Description
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.
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
No
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
No
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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