NCT03930992

Efficacy of Zoledronic Acid + Colaren vs Zoledronic Acid + Conventional Treatment for Osteoporosis in HIV+ and HIV- Men

Efficacy of 4 mg Zoledronic Acid Plus Colaren vs 4mg Zoledronic Acid + Conventional Treatment for Secondary Osteoporosis in HIV Positive and Negative Men

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Guadalajara · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Secondary Osteoporosis

Interventions

Type	Name	Description
DRUG	Colaren in HIV positive	1 Arm (HIV+): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium).
DRUG	standard treatment in HIV positive	2 Arm (HIV+): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate)
DRUG	Colaren in HIV negative	3 Arm (HIV-): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium).
DRUG	standard treatment in HIV negative	4 Arm (HIV-): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate)

Timeline

• Start date: 2019-04-17
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2019-04-29
• Last updated: 2023-12-08

Locations

1 site across 1 country: Mexico