Clinical trial NCT03930992: Efficacy of Zoledronic Acid + Colaren vs Zoledronic Acid + Conventional Treatment for Osteoporosis in HIV+ and HIV- Men
Official title: Efficacy of 4 mg Zoledronic Acid Plus Colaren vs 4mg Zoledronic Acid + Conventional Treatment for Secondary Osteoporosis in HIV Positive and Negative Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Osteoporosis
Keywords: 4 mg zoledronic acid
Colaren
HIV
Secondary Osteoporosis
Man
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
Collaborators: name: Hospital Civil de Guadalajara
First posted: 2019-04-29
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study type: Interventional, with four arms:

1. arm: 4 mg zoledronic acid annually plus colaren ® in HIV-positive;
2. arm: 4 mg zoledronic acid annually plus conventional treatment in HIV-positive;
3. arm: 4 mg zoledronic acid annually plus colaren ® in HIV-negative;
4. arm: 4 mg zoledronic acid annually plus conventional treatment in HIV-negative.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Bone turnover markers (from baseline to 12 months under treatment)
timeFrame: Time frame: from baseline, 3 and 12 months under treatment.
measure: Change from baseline of Bone mineral density at 12 months
timeFrame: Time frame: from baseline and 12 months under treatment.
Secondary outcomes:
measure: Tolerability of colaren vs standard treatment (conventional treatment): grading the severity of Adult and Pediatric Adverse Events Version 2.0
timeFrame: Time frame: evaluate the tolerability from month 1, 3, 6, 9 and 12, under supplementation
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
state: Jalisco
Study officials:
References:
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citation: Bolland MJ, Grey AB, Horne AM, Briggs SE, Thomas MG, Ellis-Pegler RB, Woodhouse AF, Gamble GD, Reid IR. Annual zoledronate increases bone density in highly active antiretroviral therapy-treated human immunodeficiency virus-infected men: a randomized controlled trial. J Clin Endocrinol Metab. 2007 Apr;92(4):1283-8. doi: 10.1210/jc.2006-2216. Epub 2007 Jan 16.
citation: Carlos F, Clark P, Maciel H, Tamayo JA. Direct costs of osteoporosis and hip fracture: an analysis for the Mexican Social Insurance Health Care System. Salud Publica Mex. 2009;51 Suppl 1:S108-13. doi: 10.1590/s0036-36342009000700014.