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Bisphosphonates
1 for Human Immunodeficiency Virus Infection
Phase 2
Waitlist Available
Led By Jeannie S. Huang, MD, MPH
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study
Awards & highlights
Study 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.
Eligible Conditions
- Human Immunodeficiency Virus Infection
- Osteopenia
- Osteoporosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bone metabolic markers
Secondary outcome measures
Safety outcomes
Side effects data
From 2008 Phase 2 trial • 68 Patients • NCT0021398041%
Hot Flash
16%
Myalgia
13%
Fatigue
13%
Pain
9%
Arthralgia
6%
Edema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Observation
Zoledronic Acid (ZA)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
Participants will receive zoledronate at study entry; their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis
Group II: 2Placebo Group1 Intervention
Participants will receive zoledronate placebo at study entry; their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zoledronic acid
FDA approved
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,439 Total Patients Enrolled
Jeannie S. Huang, MD, MPHPrincipal InvestigatorUniversity of California, San Diego
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