Back to resultsEfficacy of Zoledronic Acid + Colaren vs Zoledronic Acid + Conventional Treatment for Osteoporosis in HIV+ and HIV- Men (OSZCO)
Primary Purpose
Secondary Osteoporosis
Status
Unknown status
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Colaren in HIV positive
standard treatment in HIV positive
Colaren in HIV negative
standard treatment in HIV negative
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Osteoporosis focused on measuring 4 mg zoledronic acid, Colaren, HIV, Secondary Osteoporosis, Man
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.
Sites / Locations
- Hospital Civil de Guadalajara Fray Antonio AlcaldeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
1 Arm: Experimental
2 Arm: Active comparator
3 Arm: Experimental
4 Arm: Active comparator
Arm Description
Experimental: 4 mg zoledronic acid plus colaren ® This arm include: 20 man with HIV infection plus osteoporosis
Active comparator: 4mg zoledronic acid + standard treatment (or conventional treatment) This arm include: 20 man with HIV infection plus osteoporosis
Experimental: 4 mg zoledronic acid plus colaren ® This arm include: 20 man without HIV infection plus osteoporosis
Active comparator: 4mg zoledronic acid + standard treatment (or conventional treatment) This arm include: 20 man without HIV infection plus osteoporosis
Outcomes
Primary Outcome Measures
Change in Bone turnover markers (from baseline to 12 months under treatment)
Plasma measure of (through LEGENDplex (Multiplex)):
Bone formation panel that include: Osteoprotegerin (OPG) measure in pg/mL, Alkaline Phosphatase Liver/Bone/Kidney (ALPL) measure in pg/mL, LEPTINA measure in pg/mL and Bone Morphogenetic Protein 2 (BMP-2) measure in pg/mL. Bone resorption panel that include: Osteopontin (OPN) measure in pg/mL, Acid Phosphatase 5 Tartrate Resistant (ACP5) measure in pg/mL, RANKL measure in pg/mL, Tumor Necrosis Factor Alpha (TNF-α) measure in pg/mL, Interleukin 6 (IL-6) measure in pg/mL, Parathyroid Hormone (PTH) measure in pg/mL, Interleukin 1 beta (IL-1β) measure in pg/mL, Dickkopf WNT Signaling Pathway Inhibitor 1 (DKK-1) measure in pg/mL.
Change from baseline of Bone mineral density at 12 months
Bone mineral density through Dual-energy X-ray absorptiometry (DXA scan) measure.
Classification:
Normal: T-score ≥ -1.0 Osteopenia: -2.5 < T-score < -1.0 Osteoporosis: T-score ≤ -2.5 Severe osteoporosis: T-score ≤ -2.5 with fragility fracture
Secondary Outcome Measures
Tolerability of colaren vs standard treatment (conventional treatment): grading the severity of Adult and Pediatric Adverse Events Version 2.0
Evaluation of tolerability of Colaren and conventional treatment through the "Division of AIDS table for grading the severity of Adult and Pediatric Adverse Events Version 2.0, November 2014" Grade 1= Mild Grade 2= Moderate Grade 3= Severe Grade 4= Potentially
Full Information
NCT ID
NCT03930992
First Posted
April 17, 2019
Last Updated
April 26, 2019
Sponsor
University of Guadalajara
Collaborators
Hospital Civil de Guadalajara
1. Study Identification
Unique Protocol Identification Number
NCT03930992
Brief Title
Efficacy of Zoledronic Acid + Colaren vs Zoledronic Acid + Conventional Treatment for Osteoporosis in HIV+ and HIV- Men
Acronym
OSZCO
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara
Collaborators
Hospital Civil de Guadalajara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Osteoporosis
Keywords
4 mg zoledronic acid, Colaren, HIV, Secondary Osteoporosis, Man
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Study type: Interventional, with four arms:
arm: 4 mg zoledronic acid annually plus colaren ® in HIV-positive;
arm: 4 mg zoledronic acid annually plus conventional treatment in HIV-positive;
arm: 4 mg zoledronic acid annually plus colaren ® in HIV-negative;
arm: 4 mg zoledronic acid annually plus conventional treatment in HIV-negative.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 Arm: Experimental
Arm Type
Experimental
Arm Description
Experimental: 4 mg zoledronic acid plus colaren ® This arm include: 20 man with HIV infection plus osteoporosis
Arm Title
2 Arm: Active comparator
Arm Type
Active Comparator
Arm Description
Active comparator: 4mg zoledronic acid + standard treatment (or conventional treatment) This arm include: 20 man with HIV infection plus osteoporosis
Arm Title
3 Arm: Experimental
Arm Type
Experimental
Arm Description
Experimental: 4 mg zoledronic acid plus colaren ® This arm include: 20 man without HIV infection plus osteoporosis
Arm Title
4 Arm: Active comparator
Arm Type
Active Comparator
Arm Description
Active comparator: 4mg zoledronic acid + standard treatment (or conventional treatment) This arm include: 20 man without HIV infection plus osteoporosis
Intervention Type
Drug
Intervention Name(s)
Colaren in HIV positive
Other Intervention Name(s)
plus Zoledronic Acid 4 mg
Intervention Description
1 Arm (HIV+): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium).
Intervention Type
Drug
Intervention Name(s)
standard treatment in HIV positive
Other Intervention Name(s)
plus Zoledronic Acid 4 mg
Intervention Description
2 Arm (HIV+): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate)
Intervention Type
Drug
Intervention Name(s)
Colaren in HIV negative
Other Intervention Name(s)
plus Zoledronic Acid 4 mg
Intervention Description
3 Arm (HIV-): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium).
Intervention Type
Drug
Intervention Name(s)
standard treatment in HIV negative
Other Intervention Name(s)
plus Zoledronic Acid 4 mg
Intervention Description
4 Arm (HIV-): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate)
Primary Outcome Measure Information:
Title
Change in Bone turnover markers (from baseline to 12 months under treatment)
Description
Plasma measure of (through LEGENDplex (Multiplex)):
Bone formation panel that include: Osteoprotegerin (OPG) measure in pg/mL, Alkaline Phosphatase Liver/Bone/Kidney (ALPL) measure in pg/mL, LEPTINA measure in pg/mL and Bone Morphogenetic Protein 2 (BMP-2) measure in pg/mL. Bone resorption panel that include: Osteopontin (OPN) measure in pg/mL, Acid Phosphatase 5 Tartrate Resistant (ACP5) measure in pg/mL, RANKL measure in pg/mL, Tumor Necrosis Factor Alpha (TNF-α) measure in pg/mL, Interleukin 6 (IL-6) measure in pg/mL, Parathyroid Hormone (PTH) measure in pg/mL, Interleukin 1 beta (IL-1β) measure in pg/mL, Dickkopf WNT Signaling Pathway Inhibitor 1 (DKK-1) measure in pg/mL.
Time Frame
Time frame: from baseline, 3 and 12 months under treatment.
Title
Change from baseline of Bone mineral density at 12 months
Description
Bone mineral density through Dual-energy X-ray absorptiometry (DXA scan) measure.
Classification:
Normal: T-score ≥ -1.0 Osteopenia: -2.5 < T-score < -1.0 Osteoporosis: T-score ≤ -2.5 Severe osteoporosis: T-score ≤ -2.5 with fragility fracture
Time Frame
Time frame: from baseline and 12 months under treatment.
Secondary Outcome Measure Information:
Title
Tolerability of colaren vs standard treatment (conventional treatment): grading the severity of Adult and Pediatric Adverse Events Version 2.0
Description
Evaluation of tolerability of Colaren and conventional treatment through the "Division of AIDS table for grading the severity of Adult and Pediatric Adverse Events Version 2.0, November 2014" Grade 1= Mild Grade 2= Moderate Grade 3= Severe Grade 4= Potentially
Time Frame
Time frame: evaluate the tolerability from month 1, 3, 6, 9 and 12, under supplementation
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luz A González-Hernández, PhD
Phone
+52 3336147586
Email
lagonzalez@hcg.gob.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime F Andrade-Villanueva, MD
Phone
+52 3336145501
Email
drjandradev@cucs.udg.mx
Facility Information:
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aldo D Loza, MD
Phone
+52 3336147586
Email
danielloza444@gmail.com
First Name & Middle Initial & Last Name & Degree
José R Barrientos-Ávila, MD
First Name & Middle Initial & Last Name & Degree
Francisco Ruiz-González, MD
First Name & Middle Initial & Last Name & Degree
David E Carmona-Navarro, MD
First Name & Middle Initial & Last Name & Degree
Luz A González-Hernández, PhD MD
First Name & Middle Initial & Last Name & Degree
Jaime F Andrade-Villanueva, MD
First Name & Middle Initial & Last Name & Degree
Karina Sánchez-Reyes, PhD
First Name & Middle Initial & Last Name & Degree
Monserrat Alvarez-Zavala, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23984630
Citation
Wheater G, Elshahaly M, Tuck SP, Datta HK, van Laar JM. The clinical utility of bone marker measurements in osteoporosis. J Transl Med. 2013 Aug 29;11:201. doi: 10.1186/1479-5876-11-201.
Results Reference
result
PubMed Identifier
25091729
Citation
Sattui SE, Saag KG. Fracture mortality: associations with epidemiology and osteoporosis treatment. Nat Rev Endocrinol. 2014 Oct;10(10):592-602. doi: 10.1038/nrendo.2014.125. Epub 2014 Aug 5.
Results Reference
result
PubMed Identifier
23100110
Citation
Rothman MS, Bessesen MT. HIV infection and osteoporosis: pathophysiology, diagnosis, and treatment options. Curr Osteoporos Rep. 2012 Dec;10(4):270-7. doi: 10.1007/s11914-012-0125-0.
Results Reference
result
PubMed Identifier
23657562
Citation
Panayiotopoulos A, Bhat N, Bhangoo A. Bone and vitamin D metabolism in HIV. Rev Endocr Metab Disord. 2013 Jun;14(2):119-25. doi: 10.1007/s11154-013-9246-8.
Results Reference
result
PubMed Identifier
26286626
Citation
Leal J, Gray AM, Prieto-Alhambra D, Arden NK, Cooper C, Javaid MK, Judge A; REFReSH study group. Impact of hip fracture on hospital care costs: a population-based study. Osteoporos Int. 2016 Feb;27(2):549-58. doi: 10.1007/s00198-015-3277-9. Epub 2015 Aug 19.
Results Reference
result
PubMed Identifier
28425085
Citation
Compston J, Cooper A, Cooper C, Gittoes N, Gregson C, Harvey N, Hope S, Kanis JA, McCloskey EV, Poole KES, Reid DM, Selby P, Thompson F, Thurston A, Vine N; National Osteoporosis Guideline Group (NOGG). UK clinical guideline for the prevention and treatment of osteoporosis. Arch Osteoporos. 2017 Dec;12(1):43. doi: 10.1007/s11657-017-0324-5. Epub 2017 Apr 19.
Results Reference
result
PubMed Identifier
17227801
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.
Results Reference
result
PubMed Identifier
19287884
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.
Results Reference
result
Learn more about this trial
Efficacy of Zoledronic Acid + Colaren vs Zoledronic Acid + Conventional Treatment for Osteoporosis in HIV+ and HIV- Men
We'll reach out to this number within 24 hrs