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Status unknownNCT00102908Updated Sep 26, 2008

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

A Phase 2 interventional study of Zoledronate and Zoledronate placebo in HIV Infections, Osteopenia and Osteoporosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Status unknown at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-09-26.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2008), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • HIV Infections
  • Osteopenia
  • Osteoporosis

Keywords

  • Bone Metabolism
  • Osteopenia
  • Osteoporosis
  • Treatment Experienced
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's planned enrollment of 30 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    1

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

    Drug: Zoledronate

  • Placebo comparator
    2

    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

    Drug: Zoledronate placebo

Interventions

  • DrugZoledronate

    Zoledronate infusion

  • DrugZoledronate placebo

    Zoledronate placebo infusion

06

What researchers measure

Primary outcomes

  1. Bone metabolic markers

    Time frame: Throughout study

Secondary outcomes

  1. Safety outcomes

    Time frame: Throughout study

07

Study locations

1 site
  • University of California, San Diego
    San Diego, California 92103, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00102908
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
First posted
Feb 7, 2005
Start date
May 2005
Primary completion
Oct 2007 (estimated)
Completion
Dec 2009 (estimated)
Last update
Sep 26, 2008

Study contacts

Jeannie S. Huang, MD, MPH
principal investigator · University of California, San Diego
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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