Vitamin D and Calcium Supplement Attenuate Bone Loss Among HIV- Infected Patients Receiving Tenofovir Disoproxil Fumarate, Lamivudine or Emtricitabine and Efavirenz

Bone Density Clinical Trial

Official title:

Vitamin D and Calcium Supplement Attenuate Bone Loss Among HIV- Infected Patients Receiving Tenofovir Disoproxil Fumarate, Lamivudine or Emtricitabine and Efavirenz: An Open-label, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02827643
• Other study ID #: ID 01-59-11 ?
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2016
• Last updated: July 7, 2016
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: Mahidol University
• Contact: Patawee Boontanondha, M.D.
• Phone: 669-1774-6012
• Email: pataweeb44[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether calcium and vitamin D supplement can attenuate bone loss in HIV-infected-patients in Thailand who receive Tenofovir disoproxil fumarate.

Description:

Early initiation of antiretroviral therapy (ART) has transformed HIV infection into chronic manageable disease. Although incidence of AIDS-related mortality has decreased, it has increased for other co-morbid conditions including decrease bone mass, osteoporosis, fragility fracture. There are multi-factorial that contribute to bone loss in HIV-infected individuals including HIV virus itself that shift bone remodeling pathway toward bone resorption, lifestyle and behavioral factors, co-morbid conditions and ART.

Initiation of ART is associated with 2%-6% reduction in bone mineral density during the first 2 years of treatment regardless of ART regimens and then stabilization thereafter in the majority of the study. This magnitude of bone loss is similar to postmenopausal women during the first year.

Tenofovir disoproxil fumarate (TDF) is a nucleotide analogue reverse transcriptase inhibitor, has been associated with greater bone loss than other reverse transcriptase inhibitors, that is recommended as the first line treatment in Thailand. Nonetheless there is an evidence in western country that calcium and vitamin D supplement can attenuate bone loss in naive HIV-infected individual who start ART with TDF. Even though many experts recommend to avoid TDF and prefer abacavir, NRTIs which affect bone loss less than other NRTIs, in high fracture risk patients, more than less HIV-infected-patients can access to abacavir in resource limiting country. This research aims to study bone mineral density (BMD) in HIV infected-patient in Thai population who receive tenofovir with calcium and vitamin D supplement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• HIV-1-infected patients who start 3TC or FTC,TDF and EFV within 3 months before enrollment

• Age 18-50 years

Exclusion Criteria:

• CrCl <60mL/min/1.73 m2 ¶-

• CaCO3 supplement >500 mg/day or vitamin D supplement >800 IU/day

• Steroid used (equivalent to prednisolone> 5 mg/day more than 3 months )

• Osteoporosis treatment

• Serum Ca >10.5 g/dL

• History fragility fracture

• Pregnancy or breastfeeding

• Secondary amenorrhea

• Hyperthyroidism

• History of kidney stone

• Current active opportunistic infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bone Density

Intervention

Drug:
• TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement
Once daily calcium carbonate 1,250 mg that equal to elemental calcium 600 mg and weekly vitamin D2 20,000international units are given in intervention arms for duration of 24 weeks the subjects in this arm continue previous ART before enrollment to the study

Other:
• TDF/3TC or FTC/EFV
arm continue previous ART before enrollment to study without any intervention with standard for HIV-infected patient.

Locations

Country	Name	City	State
Thailand	Patawee Boontanondha	Faculty of Medicine Ramathibodi Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage change of bone density		24 weeks	Yes
Secondary	change in 25(OH)D level		24 weeks	Yes