Efficacy of Zoledronic Acid + Colaren vs Zoledronic Acid + Conventional Treatment for Osteoporosi… (NCT03930992) | Clinical Trial Compass
CompletedPhase 3
Efficacy of Zoledronic Acid + Colaren vs Zoledronic Acid + Conventional Treatment for Osteoporosis in HIV+ and HIV- Men
Mexico30 participantsStarted 2019-04-17
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Bone turnover markers (from baseline to 12 months under treatment)
Timeframe: Time frame: from baseline, 3 and 12 months under treatment.
2
Change from baseline of Bone mineral density at 12 months
Timeframe: Time frame: from baseline and 12 months under treatment.