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

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ClinicalTrials.gov Identifier: NCT00102908
Recruitment Status : Unknown
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was:  Active, not recruiting
First Posted : February 7, 2005
Last Update Posted : September 26, 2008
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
HIV Infections Osteopenia Osteoporosis Drug: Zoledronate Drug: Zoledronate placebo Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Bisphosphonate Therapy for HIV-Associated Osteopenia
Study Start Date : May 2005
Estimated Primary Completion Date : October 2007
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Minerals
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Bone metabolic markers [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Safety outcomes [ Time Frame: Throughout study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102908


Locations
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)
Investigators
Principal Investigator: Jeannie S. Huang, MD, MPH University of California, San Diego
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jeannie S. Huang, MD, MPH, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00102908     History of Changes
Other Study ID Numbers: 1R21AI058756-01 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2005    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: September 2008

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Bone Metabolism
Osteopenia
Osteoporosis
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Osteoporosis
Bone Diseases, Metabolic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs