drugset / Trial / NCT02322099
Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss
Phase 4
Terminated
53 enrolled
University College Dublin
Beaumont Hospital · collabHealth Research Board, Ireland · collabMater Misericordiae University Hospital · collabRoyal College of Surgeons, Ireland · collabRush University Medical Center · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Antiretroviral therapy (ART) initiation is associated with a significant loss of bone mineral density (BMD), characterised by increases in bone turnover, which is largely limited to the first 48 weeks of therapy. Bisphosphonates, such as alendronate, decrease bone turnover and can limit loss of bone mineral density. This study aims to determine if a short course of treatment with the oral bisphosphonate alendronate can limit loss of bone mineral density associated with initiation of ART in HIV-1 infected, antiretroviral naive, adult subjects.
Timeline
- Start
- 2016-05
- Primary completion
- 2019-09
- Completion
- 2019-09
Publications
- Background Cotter AG, Sabin CA, Simelane S, Macken A, Kavanagh E, Brady JJ, McCarthy G, Compston J, Mallon PW; HIV UPBEAT Study Group. Relative contribution of HIV infection, demographics and body mass index to bone mineral density. AIDS. 2014 Sep 10;28(14):2051-60. doi: 10.1097/QAD.0000000000000353.
- Background McComsey GA, Kendall MA, Tebas P, Swindells S, Hogg E, Alston-Smith B, Suckow C, Gopalakrishnan G, Benson C, Wohl DA. Alendronate with calcium and vitamin D supplementation is safe and effective for the treatment of decreased bone mineral density in HIV. AIDS. 2007 Nov 30;21(18):2473-82. doi: 10.1097/QAD.0b013e3282ef961d.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alendronic Acid | Small molecule | 70 mg | Oral |
| Comparator | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Comparator | emtricitabine | Other / unclassified | 200 mg | Oral |