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Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density

Primary Purpose

HIV Infections, Osteopenia, Osteoporosis

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zoledronate
Zoledronate placebo
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Bone Metabolism, Osteopenia, Osteoporosis, Treatment Experienced

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: HIV-infected On stable antiretroviral regimen for at least 3 months Able to walk Lumbar spine or total hip BMD T-score at least 1.5 SD and no more than 3.5 SD below the mean BMD No prevalent fractures at entry OR 1 prevalent vertebral fracture that has been asymptomatic during the last 2 years prior to study entry HIV viral load of less than 5000 copies/ml within the 2 months prior to study entry CD4 count of more than 100 cells/mm3 within the 2 months prior to study entry Willing to use acceptable forms of contraception during the study period and for 6 months after study completion. Participants who are female and postmenopausal will be required to take hormone replacement therapy during this study. Exclusion Criteria: Prior treatment with bisphosphonates or fluoride Use of supraphysiologic systemic estrogen/androgen therapy or corticosteroid therapy within the 3 months prior to study entry. Participants who have taken hormone replacement therapy are not excluded. Significant liver or kidney disease Hemoglobin less than 8 g/dL Serum calcium less than 8 mg/dL Laboratory evidence of low levels of estrogens or androgens Laboratory evidence of overactive parathyroid glands History of thyroid, parathyroid, or other endocrinologic disorder known to affect bone Current use of any therapy known to affect bone Current or history of cancer or chemotherapy Current or history of radiotherapy to the jaw Current osteomyelitis of the jaw or ongoing dental infection Recent tooth extraction or major dental procedure within 3 weeks of study entry Pregnancy or breastfeeding

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Participants will receive zoledronate at study entry; their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis

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

Outcomes

Primary Outcome Measures

Bone metabolic markers

Secondary Outcome Measures

Safety outcomes

Full Information

First Posted
February 4, 2005
Last Updated
September 25, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00102908
Brief Title
Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density
Official Title
Bisphosphonate Therapy for HIV-Associated Osteopenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2005 (undefined)
Primary Completion Date
October 2007 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief 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.
Detailed Description
Decreased BMD and bone loss is estimated to affect up to 67.5% of the HIV-infected population. HIV-associated bone loss may be a result of antiretroviral treatment (ART), but can also be caused by the infection itself. To date, treatment for this bone loss has not been established. Before prescribing drugs to treat bone loss, physicians must take into account patients' already demanding ART schedules and potential nonadherence. This study will evaluate the efficacy of a single IV dose of zoledronate, an investigational bisphosphonate, in treating HIV-associated bone loss. This study will last 1 year. Participants will be randomly assigned to receive zoledronate or placebo at study entry; their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis. There will be 7 study visits: at screening, study entry, Week 2, and Months 3, 6, 9, and 12. Blood collection will occur at all visits. Medical history, a physical exam, a dual-energy x-ray absorptiometry (DEXA) scan to measure bone density, and a nutrition evaluation will occur at selected visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Osteopenia, Osteoporosis
Keywords
Bone Metabolism, Osteopenia, Osteoporosis, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive zoledronate at study entry; their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Zoledronate
Intervention Description
Zoledronate infusion
Intervention Type
Drug
Intervention Name(s)
Zoledronate placebo
Intervention Description
Zoledronate placebo infusion
Primary Outcome Measure Information:
Title
Bone metabolic markers
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Safety outcomes
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-infected On stable antiretroviral regimen for at least 3 months Able to walk Lumbar spine or total hip BMD T-score at least 1.5 SD and no more than 3.5 SD below the mean BMD No prevalent fractures at entry OR 1 prevalent vertebral fracture that has been asymptomatic during the last 2 years prior to study entry HIV viral load of less than 5000 copies/ml within the 2 months prior to study entry CD4 count of more than 100 cells/mm3 within the 2 months prior to study entry Willing to use acceptable forms of contraception during the study period and for 6 months after study completion. Participants who are female and postmenopausal will be required to take hormone replacement therapy during this study. Exclusion Criteria: Prior treatment with bisphosphonates or fluoride Use of supraphysiologic systemic estrogen/androgen therapy or corticosteroid therapy within the 3 months prior to study entry. Participants who have taken hormone replacement therapy are not excluded. Significant liver or kidney disease Hemoglobin less than 8 g/dL Serum calcium less than 8 mg/dL Laboratory evidence of low levels of estrogens or androgens Laboratory evidence of overactive parathyroid glands History of thyroid, parathyroid, or other endocrinologic disorder known to affect bone Current use of any therapy known to affect bone Current or history of cancer or chemotherapy Current or history of radiotherapy to the jaw Current osteomyelitis of the jaw or ongoing dental infection Recent tooth extraction or major dental procedure within 3 weeks of study entry Pregnancy or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannie S. Huang, MD, MPH
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

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Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density

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