Clinical Trials


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

The recruitment status of this study is unknown.

Verified September 2008

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID) Identifier

First received: February 4, 2005
Last updated: September 25, 2008
Last Verified: September 2008
History of Changes


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.

Condition Intervention Phase
HIV Infections

Drug : Zoledronate
Drug : Zoledronate placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Bisphosphonate Therapy for HIV-Associated Osteopenia

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures

  • Bone metabolic markers [ Time Frame: Throughout study ]
Secondary Outcome Measures:
  • Safety outcomes [ Time Frame: Throughout study ]

Estimated Enrollment: 30
Study Start Date: May 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Zoledronate infusion

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

Zoledronate placebo infusion

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.



Ages Eligible for Study: 18 Years to 70 Years  
Sexes Eligible for Study: 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:
  • 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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00102908


United States, California
University of California, San Diego
San Diego, California, United States, 92103

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)


Principal Investigator: Jeannie S. Huang, MD, MPH University of California, San Diego
More Information

More Information

Responsible Party: Jeannie S. Huang, MD, MPH, University of California, San Diego Identifier: NCT00102908   History of Changes  
Other Study ID Numbers: 1R21AI058756-01  
Study First Received: February 4, 2005  
Last Updated: September 25, 2008  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Bone Metabolism
Treatment Experienced

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Zoledronic Acid processed this data on May 24, 2020
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