Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT03930992
Brief 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.
Study:
NCT03930992
Study Brief:
Protocol Section:
NCT03930992