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

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ClinicalTrials.gov Identifier: NCT03930992
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
Hospital Civil de Guadalajara
Information provided by (Responsible Party):
Luz Alicia González Hernández, University of Guadalajara

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.


Condition or disease Intervention/treatment Phase
Secondary Osteoporosis Drug: Colaren in HIV positive Drug: standard treatment in HIV positive Drug: Colaren in HIV negative Drug: standard treatment in HIV negative Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Arm: Experimental
Experimental: 4 mg zoledronic acid plus colaren ® This arm include: 20 man with HIV infection plus osteoporosis
Drug: Colaren in HIV positive
1 Arm (HIV+): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium).
Other Name: plus Zoledronic Acid 4 mg

Active Comparator: 2 Arm: Active comparator
Active comparator: 4mg zoledronic acid + standard treatment (or conventional treatment) This arm include: 20 man with HIV infection plus osteoporosis
Drug: standard treatment in HIV positive
2 Arm (HIV+): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate)
Other Name: plus Zoledronic Acid 4 mg

Experimental: 3 Arm: Experimental
Experimental: 4 mg zoledronic acid plus colaren ® This arm include: 20 man without HIV infection plus osteoporosis
Drug: Colaren in HIV negative
3 Arm (HIV-): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium).
Other Name: plus Zoledronic Acid 4 mg

Active Comparator: 4 Arm: Active comparator
Active comparator: 4mg zoledronic acid + standard treatment (or conventional treatment) This arm include: 20 man without HIV infection plus osteoporosis
Drug: standard treatment in HIV negative
4 Arm (HIV-): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate)
Other Name: plus Zoledronic Acid 4 mg




Primary Outcome Measures :
  1. Change in Bone turnover markers (from baseline to 12 months under treatment) [ Time Frame: Time frame: from baseline, 3 and 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.


  2. Change from baseline of Bone mineral density at 12 months [ Time Frame: Time frame: from baseline and 12 months under treatment. ]

    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 :
  1. Tolerability of colaren vs standard treatment (conventional treatment): grading the severity of Adult and Pediatric Adverse Events Version 2.0 [ Time Frame: Time frame: evaluate the tolerability from month 1, 3, 6, 9 and 12, under supplementation ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930992


Contacts
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Contact: Luz A González-Hernández, PhD +52 3336147586 lagonzalez@hcg.gob.mx
Contact: Jaime F Andrade-Villanueva, MD +52 3336145501 drjandradev@cucs.udg.mx

Locations
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Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde Recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Aldo D Loza, MD    +52 3336147586    danielloza444@gmail.com   
Sub-Investigator: José R Barrientos-Ávila, MD         
Sub-Investigator: Francisco Ruiz-González, MD         
Sub-Investigator: David E Carmona-Navarro, MD         
Principal Investigator: Luz A González-Hernández, PhD MD         
Sub-Investigator: Jaime F Andrade-Villanueva, MD         
Sub-Investigator: Karina Sánchez-Reyes, PhD         
Sub-Investigator: Monserrat Alvarez-Zavala, PhD         
Sponsors and Collaborators
University of Guadalajara
Hospital Civil de Guadalajara

Publications of Results:

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Responsible Party: Luz Alicia González Hernández, Head of HIV Unit in Hospital Civil de Guadalajara, University of Guadalajara
ClinicalTrials.gov Identifier: NCT03930992     History of Changes
Other Study ID Numbers: OSZCO
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Luz Alicia González Hernández, University of Guadalajara:
4 mg zoledronic acid
Colaren
HIV
Secondary Osteoporosis
Man

Additional relevant MeSH terms:
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Osteoporosis
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic Acid
Calcium Carbonate
Bone Density Conservation Agents
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents