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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Unknown status

CT.gov ID

NCT00102908

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 1, 2005

Anticipated Primary Completion Date :

Oct 1, 2007

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

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

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

Primary Outcome Measures

Bone metabolic markers [Throughout study]

Secondary Outcome Measures

Safety outcomes [Throughout study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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