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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00102908
First received: February 4, 2005
Last updated: September 25, 2008
Last verified: September 2008

February 4, 2005
September 25, 2008
May 2005
October 2007   (final data collection date for primary outcome measure)
Bone metabolic markers [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Bone metabolic markers
Complete list of historical versions of study NCT00102908 on ClinicalTrials.gov Archive Site
Safety outcomes [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Safety outcomes
Not Provided
Not Provided
 
Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density
Bisphosphonate Therapy for HIV-Associated Osteopenia

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • HIV Infections
  • Osteopenia
  • Osteoporosis
  • Drug: Zoledronate
    Zoledronate infusion
  • Drug: Zoledronate placebo
    Zoledronate placebo infusion
  • 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
    Intervention: 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
    Intervention: Drug: Zoledronate placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
December 2009
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00102908
1R21-AI058756-01, 1R21AI058756-01
Not Provided
Jeannie S. Huang, MD, MPH, University of California, San Diego
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Jeannie S. Huang, MD, MPH University of California, San Diego
National Institute of Allergy and Infectious Diseases (NIAID)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP