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
  Purpose

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
Osteopenia
Osteoporosis
Drug: Zoledronate
Drug: Zoledronate placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Bisphosphonate Therapy for HIV-Associated Osteopenia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Bone metabolic markers [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety outcomes [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00102908

Locations
United States, California
University of California, San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
Investigators
Principal Investigator: Jeannie S. Huang, MD, MPH University of California, San Diego
  More Information

Additional Information:
No publications provided

Responsible Party: Jeannie S. Huang, MD, MPH, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00102908     History of Changes
Other Study ID Numbers: 1R21-AI058756-01, 1R21AI058756-01
Study First Received: February 4, 2005
Last Updated: September 25, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 24, 2014