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Can a common bone drug help HIV patients fight osteoporosis?

NCT ID NCT00120757

Disease control Sponsor: French National Agency for Research on AIDS and Viral Hepatitis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether alendronate, a drug used for osteoporosis, can improve bone density in people with HIV. 140 participants received either alendronate or a placebo, along with calcium and vitamin D, for 2 years. The goal was to see if the drug could strengthen bones and reduce fracture risk in this population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

140 people

Start date

Oct 2004

Finished

Nov 2008

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Non-pregnant * Non menopausal women * Total femur BMD below -2.5 SD (T score) or lumbar spine BMD below -2.5 SD (T score) or BMD below -1 associated with a vertebral osteoporotic fracture (diminution of vertebral height over 20%) * HIV infection known for at least 5 years * CD4 cell count over 50/mm3 * Karnofsky score over or equal to 70 * Written informed consent. Exclusion Criteria: * Osteoporosis resulting from a cause other than HIV: vitamin D deficiency (in that case, after receiving high-dose calcium and vitamin D for 1 month, patients will be randomized without a new screening), renal failure, heart failure (NHYA class III or IV), treatment with glucocorticoid at a dose over or equal to 0.5mg/kg/d for 15 days or more at time of inclusion or during the previous 6 months; thyroid or other endocrine disease if untreated for more than 6 months; hypercalciuria * Testosterone below normal if treatment is hormonal * BMI below or equal to 18 * Severe lung failure * Chronic alcohol intoxication * Ongoing opportunistic infection * Gastric ulcer of disease interfering with oesophageal motility in the previous 3 months * History of treatment for osteoporosis * History of malignancy in the previous 5 years (except skin cancer and Kaposi) * Cytotoxic chemotherapy or cytokine therapy * Liver cirrhosis * Breast feeding

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Conditions

The condition(s) this trial relates to.

HIV infectious disease osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections Osteoporosis

Contacts and locations

Locations

  • Hôpital Necker service des Maladies Infectieuses

    Paris, 75015, France

  • Service de Medecine Interne hopital Avicenne

    Bobigny, 93009 cedex, France

  • Service de Rhumatologie hopital Pitie-Salpetriere

    Paris, 75013, France

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