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

University of Guadalajara

Status and phase: Completed; Phase 3

Conditions: Secondary Osteoporosis

Treatments: Drug: standard treatment in HIV positive; Drug: Colaren in HIV positive; Drug: standard treatment in HIV negative; Drug: Colaren in HIV negative

Study type: Interventional

Funder types: Other

Identifiers

NCT03930992

OSZCO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult males 18 to 65 years old.
• HIV diagnosis (HIV positive group) or negative HIV serology (HIV negative group).
• Patients receiving HAART and sustained virologic control for at least two years.
• Patients meeting diagnostic criteria for osteoporosis.
• Subjects willing to participate voluntarily in this study and give a written consent.
• Estimated glomerular filtration rate >60 mL/min (Using CKD-EPI formula).

Exclusion criteria

• Use of calcium, vitamin D or any other drug with bone activity during the last 90 days previous to the study.
• Use of herbs or herb products during the last 90 days previous to the study.
• Positive test for HCV or HBV.
• Patients who cannot be submitted to complete examination for variable analysis.
• Glomerular filtration rate <60 mL/minute.
• Active liver disease.
• Non-compliance to treatment (less than 90%).
• Patients who are not willing to continue participating.

Non-inclusion criteria:

• Female patients.
• Use of immunosuppressive o immunomodulatory treatment 90 days previous to selection.
• Use of prohibited drugs for the study like: antiestrogens, corticosteroids (doses greater than 7.5mg of prednisone/day) 90 days previous to selection.
• Use of hormone therapy.
• Patients with history or actual use of chemotherapy.
• Patients deprived of freedom or imprisoned patients with mental illnesses.
• Participant is part of another clinical trial or nutritional program.
• Hypogonadism diagnosis with not having received hormonal replacement previous to the study.
• Primary osteoporosis diagnosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 4 patient groups

1 Arm: Experimental

Experimental group

Description:

Experimental: 4 mg zoledronic acid plus colaren ® This arm include: 20 man with HIV infection plus osteoporosis

Treatment:

Drug: Colaren in HIV positive

2 Arm: Active comparator

Active Comparator group

Description:

Active comparator: 4mg zoledronic acid + standard treatment (or conventional treatment) This arm include: 20 man with HIV infection plus osteoporosis

Treatment:

Drug: standard treatment in HIV positive

3 Arm: Experimental

Experimental group

Description:

Experimental: 4 mg zoledronic acid plus colaren ® This arm include: 20 man without HIV infection plus osteoporosis

Treatment:

Drug: Colaren in HIV negative

4 Arm: Active comparator

Active Comparator group

Description:

Active comparator: 4mg zoledronic acid + standard treatment (or conventional treatment) This arm include: 20 man without HIV infection plus osteoporosis

Treatment:

Drug: standard treatment in HIV negative