Prevention of Bone loss in HIV-infected patients taking Highly Active Antiretroviral Therapy with Zoledronate

Phase 4

Completed

• Conditions: HIV-related osteopenia; HIV-related osteoporosis; Inflammatory and Immune System - Acquired immune deficiency syndrome (AIDS / HIV); Musculoskeletal - Osteoporosis

• Registration Number: ACTRN12605000208606
• Lead Sponsor: Associate Professor A Grey

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

HIV positive and have taken HAART for at least 3 months and have a bone mineral density T score of less than -0.5SD at any site.

Exclusion Criteria

Renal impairment (serum creatinine >0.15 mmol/L), untreated hypothyroidism or hyperthyroidism, chronic liver disease, concurrent major systemic illness, including malignancy, active major gastrointestinal disease, metabolic bone diseases, primary hyperparathyroidism, more than 2 hospital admissions within 6 months of study entry, use of oral glucocorticoid drugs equivalent to an average dose of prednisone 2.5 mg/day in the preceding six months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in spine bone density over 2 years in the zoledronate-treated group compared to the change in the control group.[]

Secondary Outcome Measures

Name	Time	Method
The change in hip bone density in the zoledronate-treated group compared to the change in the control group.[Over 2 years.];The change in bone turnover markers in the zoledronate-treated group compared to the change in the control group.[Over 2 years. ]