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HIV InfectionsPhase 2NCT00061256

The Effect of Alendronate, Calcium, and Vitamin D on Bone Mineral Density in HIV Infected Patients

A Phase 2 study testing Alendronate, Calcium carbonate and Vitamin D in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Alendronate is a drug that is used to treat osteoporosis. The purpose of this study is to examine whether alendronate in combination with calcium and vitamin D is safe and effective for treating bone loss in people with HIV. Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
HIV Infections
What is being tested?
Alendronate, Calcium carbonate and Vitamin D
How many people
80 participants
Where
28 sitesUnited States
Study dates
Start not givento Sep 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HIV-1 infection
  • Lumbar spine DEXA scan confirming decreased BMD within 90 days prior to study entry
  • CD4 cell count 100 cells/mm3 or more within 30 days prior to study entry
  • Stable antiretroviral regimen for at least 12 weeks prior to study entry
  • No plans to alter antiretroviral therapy or to initiate structured/strategic treatment interruptions
  • No plans to significantly alter exercise habits or diet for the duration of the study
Show all 11Show fewer
  • Documentation of two consecutive measurements of viral load of 5000 copies/ml or less within 90 days prior to study entry, with at least one of the two values obtained within 30 days prior to study entry
  • Willing to use acceptable methods of contraception
  • For women with the absence of menses for at least 6 months, serum prolactin level in the normal range within 60 days prior to study entry
  • For women taking estrogen therapy, stable estrogen regimen for at least 24 weeks prior to study entry, with no plan to change estrogen dose for the duration of the study
  • Serum calcium between 8 mg/dl and 11 mg/dl within 30 days prior to study entry

Who cannot join

  • Men with untreated low total serum testosterone levels within 60 days prior to study entry, or men with plans to initiate testosterone replacement during the study
  • Cannot receive vitamin D or calcium supplements
  • Daily vitamin or dietary supplements that include 10,000 IU or greater of vitamin A within 90 days prior to study entry
  • Hyperparathyroidism, vitamin D deficiency, or oral thrush within 60 days prior to study entry
  • Any current or past conditions that predispose to disorders involving the esophagus. Participants with a history of mild or controlled reflux may be enrolled.
  • Esophagitis within 6 months prior to study entry
Show all 21Show fewer
  • Pregnant or breastfeeding
  • Paget's disease
  • Spinal fracture (thoracic or lumbar spine) within 60 days prior to study entry
  • Atraumatic bone fracture at any time since 18 years of age
  • Spinal fracture at any time in the past
  • Inability to stand or sit upright for at least 30 minutes
  • Use of systemic glucocorticoids for a cumulative duration of longer than 4 weeks within 6 months immediately prior to study entry
  • Use of medications for treatment of osteoporosis within 12 months prior to study entry
  • Allergy/hypersensitivity to any component of alendronate, the components of the tablet, or bisphosphonate compounds
  • Active drug or alcohol dependence which, in the opinion of the investigator, would interfere with adherence to study requirements or would endanger the patient's health while on study
  • Hospitalization for alcohol-related liver disease at any time in the past
  • Current use of systemic cytotoxic chemotherapy
  • Acute illness within 30 days prior to study entry which, in the opinion of the investigator, would interfere with participation in the study
  • History of hepatitis C virus infection
  • For participants using anabolic steroids, use of steroids for less than 6 months prior to entry or plans to change current regimen during the course of the study; if a steroid regimen has been discontinued, it must have been discontinued at least 6 months prior to entry

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United States28 sites

  • University of Alabama-Birmingham

    Birmingham, Alabama, 35294-2050

  • Univ of North Carolina

    Chapel Hill, North Carolina, 27514

  • Northwestern University

    Chicago, Illinois, 60611-5012

  • Cook County Hospital Core Center

    Chicago, Illinois, 60612

  • Case Western Reserve Univ

    Cleveland, Ohio, 44106-5083

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109-1998

  • Ohio State University

    Columbus, Ohio, 43210

  • Univ of Texas, Galveston

    Galveston, Texas, 77555-0435

  • Indiana Univ Hosp

    Indianapolis, Indiana, 46202-5250

  • Methodist Hosp of Indiana

    Indianapolis, Indiana, 46202-5250

  • Wishard Hosp

    Indianapolis, Indiana, 46202

  • UCLA School of Medicine

    Los Angeles, California, 90095-1793

  • Univ of Minnesota

    Minneapolis, Minnesota, 55455-0392

  • Comprehensive Care Clinic

    Nashville, Tennessee, 37203

  • Chelsea Clinic

    New York, New York, 10011

  • NYU/Bellevue

    New York, New York, 10016-6481

  • Nebraska Health System

    Omaha, Nebraska, 68198-5130

  • University of Pennsylvania, Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Rhode Island Hosp

    Providence, Rhode Island, 02906

  • Stanley Street Treatment and Resource

    Providence, Rhode Island, 02906

  • The Miriam Hosp

    Providence, Rhode Island, 02906

  • AIDS Community Health Center

    Rochester, New York, 14642-0001

  • Univ of Rochester Med Ctr

    Rochester, New York, 14642-0001

  • University of California, San Diego

    San Diego, California, 92103

  • San Francisco General Hospital

    San Francisco, California, 94110

  • University of Washington (Seattle)

    Seattle, Washington, 98104

  • Stanford Univ

    Stanford, California, 94305-5107

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Once-Weekly Alendronate in HIV-Infected Subjects With Decreased Bone Mineral Density Receiving Calcium and Vitamin D

Alendronate is a drug that is used to treat osteoporosis. The purpose of this study is to examine whether alendronate in combination with calcium and vitamin D is safe and effective for treating bone loss in people with HIV.

Read the detailed description

Decreased bone mineral density (BMD) has been identified in up to 50% of HIV infected men, with severe osteoporosis in up to 21% of these men. The mechanisms underlying these bone abnormalities remain unclear. Bisphosphonates are potent bone resorption inhibitors and have been shown to be effective in treating osteoporosis. While several bisphosphonates are approved for the treatment of osteoporosis in women, alendronate is the only bisphosphonate approved for treatment in men. This study hypothesizes that alendronate will be able to reverse decreased BMD secondary to inhibition of bone resorption in HIV infected patients treated with potent antiretroviral therapy, and that these patients will be able to tolerate alendronate without any significant toxicities. The study will also examine the efficacy of once-weekly alendronate with daily calcium and vitamin D in both men and women with HIV.

Patients will participate in this study for 48 weeks. Patients will be randomly assigned to receive either alendronate or placebo. All patients will receive calcium and vitamin D. Dual energy x-ray absorptiometry (DEXA) scans will be used to evaluate bone density at each visit. After study entry, patients will have visits at Weeks 2, 12, 24, 36, and 48. During these visits, blood will be drawn and a pregnancy test may be performed. Patients must fast for at least 8 hours prior to the entry visit and for the visits at Weeks 2, 12, 24, and 48.

Conditions
HIV Infections
Being tested
Alendronate, Calcium carbonate, Vitamin D
Keywords
Bone Mineral Density, Lumbar Vertebrae, Treatment Experienced
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlendronateDrug

  • Calcium carbonateDrug

  • Vitamin DDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2003 (estimated)
  2. Study completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
80 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00061256
Sponsor's protocol ID
ACTG A5163
Other IDs
DAIDS-ES ID 10089
Status last verified
Aug 2009
First submitted
22 May 2003
Last updated
7 Aug 2009
Results posted
No

Publications

  • Tebas P, Powderly WG, Claxton S, Marin D, Tantisiriwat W, Teitelbaum SL, Yarasheski KE. Accelerated bone mineral loss in HIV-infected patients receiving potent antiretroviral therapy. AIDS. 2000 Mar 10;14(4):F63-7. doi: 10.1097/00002030-200003100-00005.

    PubMed 10770534

  • Reid IR. The roles of calcium and vitamin D in the prevention of osteoporosis. Endocrinol Metab Clin North Am. 1998 Jun;27(2):389-98. doi: 10.1016/s0889-8529(05)70011-6.

    PubMed 9669144

  • Orwoll E, Ettinger M, Weiss S, Miller P, Kendler D, Graham J, Adami S, Weber K, Lorenc R, Pietschmann P, Vandormael K, Lombardi A. Alendronate for the treatment of osteoporosis in men. N Engl J Med. 2000 Aug 31;343(9):604-10. doi: 10.1056/NEJM200008313430902.

    PubMed 10979796

  • Schnitzer T, Bone HG, Crepaldi G, Adami S, McClung M, Kiel D, Felsenberg D, Recker RR, Tonino RP, Roux C, Pinchera A, Foldes AJ, Greenspan SL, Levine MA, Emkey R, Santora AC 2nd, Kaur A, Thompson DE, Yates J, Orloff JJ. Therapeutic equivalence of alendronate 70 mg once-weekly and alendronate 10 mg daily in the treatment of osteoporosis. Alendronate Once-Weekly Study Group. Aging (Milano). 2000 Feb;12(1):1-12.

    PubMed 10746426

  • Mondy K, Tebas P. Emerging bone problems in patients infected with human immunodeficiency virus. Clin Infect Dis. 2003 Apr 1;36(Suppl 2):S101-5. doi: 10.1086/367566.

    PubMed 12652379

  • 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.

    PubMed 18025884

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alendronate, Calcium carbonate and Vitamin D in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00061256, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2009.

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