Efficacy of Zoledronic Acid + Colaren vs Zoledronic Acid + Conventional Treatment for Osteoporosis in HIV+ and HIV- Men
Condition: Secondary Osteoporosis
MeSH terms: Neoplasm Metastasis; Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical trial to assess the effectiveness of the supplement Colaren® associated with
      zoledronic acid 4mg/annually in the treatment of osteoporosis secondary, compared to standard
      treatment plus zoledronic acid 4mg/annually. The standard treatment will include 1gr of
      calcium/day and vitamin D supplement. In both cases, vitamin D levels will be determinated,
      which should remain at more than 30 ng/mL.

      Including men with osteoporosis secondary to HIV and men with osteoporosis secondary to any
      other cause (HIV negative). Vitamin D levels, bone densitometry and markers of metabolism,
      bone formation and bone resorption will be assessment. The all parameters above will be
      assessed basally (before the start of treatment), after starting the treatment, an assessment
      will be made at 12 weeks where vitamin D levels and bone markers will be measured. Meanwhile,
      at week 24 assess only vitamin D levels; and finally, at week 52 all parameters mentioned
      above will be measured.
    

Detailed description: 
      This study is a clinical trial to assess the effectiveness of the supplement Colaren®
      associated with annually zoledronic acid 4mg, in the treatment of osteoporosis secondary or
      not to HIV infection, compared to standard treatment plus zoledronic acid 4mg/annually. The
      standard treatment will include 1gr of calcium/day and vitamin D supplement. In both cases,
      vitamin D levels will be evaluated, which should remain at more than 30 ng/mL.

      Including men with osteoporosis secondary to HIV and men with osteoporosis secondary to any
      other cause (HIV negative). Vitamin D levels, bone densitometry and markers of metabolism,
      bone formation and bone resorption will be assessment. The all parameters above will be
      assessed basally (before the start of treatment), after starting the treatment, an assessment
      will be made at 12 weeks where vitamin D levels and bone markers will be measured. Meanwhile,
      at week 24 assess only vitamin D levels; and finally, at week 52 all parameters mentioned
      above will be measured.
    

Intervention name(s): Colaren in HIV positive; standard treatment in HIV positive; Colaren in HIV negative; standard treatment in HIV negative
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 Arm (HIV+): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium).; 2 Arm (HIV+): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate); 3 Arm (HIV-): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium).; 4 Arm (HIV-): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate)
Other intervention name(s): plus Zoledronic Acid 4 mg; plus Zoledronic Acid 4 mg; plus Zoledronic Acid 4 mg; plus Zoledronic Acid 4 mg
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study type: Interventional, with four arms:
arm: 4 mg zoledronic acid annually plus colaren ® in HIV-positive;
arm: 4 mg zoledronic acid annually plus conventional treatment in HIV-positive;
arm: 4 mg zoledronic acid annually plus colaren ® in HIV-negative;
arm: 4 mg zoledronic acid annually plus conventional treatment in HIV-negative.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 4 mg zoledronic acid; Colaren; HIV; Secondary Osteoporosis; Man