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
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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 |
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 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 |

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
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Drug: Zoledronate
Zoledronate infusion
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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
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Drug: Zoledronate placebo
Zoledronate placebo infusion
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- Bone metabolic markers [ Time Frame: Throughout study ]
- Safety outcomes [ Time Frame: Throughout study ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
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

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
United States, California | |
University of California, San Diego | |
San Diego, California, United States, 92103 |
Principal Investigator: | Jeannie S. Huang, MD, MPH | University of California, San Diego |
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 |