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Preventing Bone Loss Among Chinese Patients With HIV on ART

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03598556
Recruitment Status : Active, not recruiting
First Posted : July 26, 2018
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
Beijing YouAn Hospital
Beijing Ditan Hospital
Guangxi Autonomous Region Longtan Hospital
Fuzhou Infectious Diseases Hospital
Shenzhen Third People's Hospital
Yale University
Information provided by (Responsible Party):
LI Taisheng, Peking Union Medical College Hospital

Tracking Information
First Submitted Date  ICMJE July 15, 2018
First Posted Date  ICMJE July 26, 2018
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2018)
Change in Bone Mineral Density (BMD) [ Time Frame: Baseline to week 48 ]
In the three sites in Beijing (N=400), compare percent change in BMD at the lumbar spine and total hip, as measured by dual-energy x-ray absorptiometry (DXA) at week 48.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2018)
  • Immediate vs. Delayed Vitamin D3 Supplementation [ Time Frame: Weeks 48 to 96 ]
    In the three sites in Beijing (N=400), from 48 to 96 weeks, switch the placebo arm to vitamin D3 supplementation to compare percent change in BMD at 96 weeks between patients who initiated vitamin D3 supplementation at the start of ART versus those who initiated vitamin D3 after 1 year of ART.
  • Change in Quantitative Ultrasound (QUS) Measures [ Time Frame: Baseline to 96 weeks ]
    In all six study sites (N=600), evaluate percent change in SOS and BUA over 48 weeks in the vitamin D treatment group compared with placebo, as measured by QUS. Further, evaluate the ability of QUS to independently identify the same group of patients at greatest risk for severe bone loss, as compared with risk stratification using DXA.
  • Change in Biochemical Markers [ Time Frame: Baseline to 96 weeks ]
    To measure the effect of the proposed intervention on markers of vitamin D and bone metabolism, inflammation and HIV disease status.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing Bone Loss Among Chinese Patients With HIV on ART
Official Title  ICMJE Strategies for the Prevention of Bone Loss Among Patients With HIV on Antiretroviral Therapy in China
Brief Summary The major goal of this study will be to conduct a randomized, double-blind, placebo-controlled, clinical trial of intermittent high-dose vitamin D3 supplementation (180,000IU) given at the point of care (every 3 months) after initiation of ART with tenofovir/ lamivudine/ efavirenz to compare its ability to mitigate reductions in bone mineral density over 12 months compared to placebo.
Detailed Description

Studies among adult and pediatric populations have suggested vitamin D supplementation may be efficacious for mitigating the bone loss seen with tenofovir-based antiretroviral therapy (ART). Because patients with HIV face significant pill burden, competing priorities and health care associated costs, we seek to explore a pragmatic approach to prevention. The investigators propose a randomized controlled, double-blind, placebo intervention trial to assess the efficacy, tolerability, and safety of an intermittent high-dose vitamin D3 supplementation regimen given quarterly at the point of care for adult patients receiving free ART through the China National Free AIDS Treatment Program. The period of supplementation will be limited to the first 48 weeks after treatment initiation when ART-associated bone loss is most pronounced. This will be followed by supplementation of all participants with vitamin D3 from 48 to 96 weeks to compare the impact of early vitamin D3 supplementation (at ART initiation) versus late vitamin D3 supplementation (at 48 weeks) on change in BMD.

Furthermore, despite the rapid rise in access to ART in China, infrastructure to diagnose and manage osteoporosis is not always easily accessible for patients with HIV in China due to limited availability of dual-energy x-ray absorptiometry (DXA), the gold standard for BMD measurement. Therefore, the current proposal also seeks to bridge this gap by exploring the potential applications of quantitative ultrasound (QUS), a portable and low-cost method of assessing BMD that has been demonstrated to reliably predict fracture, in HIV care settings.

A total of 400 treatment-naïve Chinese adults diagnosed with HIV from 3 study sites in Beijing will be enrolled and followed with serial DXA exams to evaluate the primary aim. These 400 patients plus another 200 participants from 3 additional study sites from Fuzhou, Shenzhen, and Guangxi province, will be evaluated with serial QUS ultrasound examinations for the secondary aims. Serum and urine samples will be collected and stored at pre-specified time points.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind
Primary Purpose: Prevention
Condition  ICMJE
  • HIV/AIDS
  • Osteoporosis
  • Bone Loss
Intervention  ICMJE
  • Dietary Supplement: Vitamin D3
    180,000IU Vitamin D3 oral emulsion
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Vitamin D3 Supplementation Arm
    This arm will receive 180,000IU vitamin D3 every 3 months from baseline through week 96.
    Intervention: Dietary Supplement: Vitamin D3
  • Placebo Comparator: Placebo Arm
    This arm will receive placebo every 3 months from baseline through week 48, followed by 180,000IU vitamin D3 every 3 months from week 48 through week 96.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2018)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Willingness and availability to engage in study activities for the duration of the study
  • Documented HIV-1 infection (confirmed by Western blot)
  • ART naïve at the time of enrollment
  • Eligible to initiate ART (TDF/3TC/EFV) within 1 month
  • Ability to take oral medication and be willing to adhere to the mediation regimen
  • For females of reproductive potential: use of highly effective contraception

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • AIDS-defining illness within 2 weeks of entry
  • Liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)
  • Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)
  • Patients with a history of injection drug usage
  • Known history of osteoporosis, osteoporotic fracture, or other metabolic/inherited bone disorder
  • History of treatment with prescription therapies for osteoporosis (for example: bisphosphonates, denosumab, teriparatide, selective estrogen receptor modifying agents, active forms of vitamin D).
  • Unwillingness to discontinue previous vitamin D supplementation, if any, at time of enrollment
  • Rheumatoid arthritis
  • Malabsorption or inflammatory bowel disease
  • Hyperparathyroidism, hypercalcemia, or hypocalcemia
  • History of kidney stones
  • Poorly controlled thyroid disease
  • History of neuromuscular disorder/movement disorder, stroke or seizures
  • History of significant neurocognitive disorders (including mental health conditions or dementia)
  • Glucocorticoids, estrogen, testosterone, or anticonvulsant use within the past six months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03598556
Other Study ID Numbers  ICMJE CACT 1807
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LI Taisheng, Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE
  • Beijing YouAn Hospital
  • Beijing Ditan Hospital
  • Guangxi Autonomous Region Longtan Hospital
  • Fuzhou Infectious Diseases Hospital
  • Shenzhen Third People's Hospital
  • Yale University
Investigators  ICMJE
Principal Investigator: Taisheng Li, MD, PhD Peking Union Medical College Hospital
PRS Account Peking Union Medical College Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP