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

NCT00102908 | Unknown Phase 2

• 1 other identifier: 1R21AI058756-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Osteopenia; Osteoporosis

Keywords

Bone Metabolism; Osteopenia; Osteoporosis; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Bone metabolic markers

  Throughout study

Secondary Outcomes (1)

• Safety outcomes

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

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

Interventions

Zoledronate DRUG

Zoledronate infusion

1

Zoledronate placebo DRUG

Zoledronate placebo infusion

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

HIV Infections; Bone Diseases, Metabolic; Osteoporosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jeannie S. Huang, MD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 4, 2005
• First Posted: February 7, 2005
• Study Start: May 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: December 1, 2009
• Last Updated: September 26, 2008

Record last verified: 2008-09

Locations

US (1)