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New Bone-Boosting drug shows promise for osteoporosis

NCT ID NCT06577935

Disease control Sponsor: Angitia Biopharmaceuticals 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests an experimental drug called AGA2118 in postmenopausal women aged 55 to 80 who have low bone density but no history of fractures. The goal is to see if the drug can safely increase bone mineral density over 12 months compared to a placebo. About 379 women will participate in this double-blind, dose-finding trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AGA2118
What this could lead to
If successful, this could lead to a new treatment option that helps strengthen bones and reduce fracture risk in postmenopausal women with osteoporosis.
What could go wrong
This is an early Phase 2 dose-finding study, so it is not yet proven to work. The results may not lead to a final approved treatment, and side effects are still being evaluated.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

379 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

55 to 80 years

Sex

Female participants only

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: * Healthy, ambulatory, postmenopausal women age ≥ 55 to ≤ 80. * BMD T-score of ≤ -2.5 to \> -3.5 at the lumbar spine, total hip, or femoral neck. Exclusion Criteria: * History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis. * Vitamin D deficiency. * Known intolerance to calcium or vitamin D supplements. * Untreated hyper- or hypothyroidism. * Current hyper- or hypoparathyroidism. * Elevated transaminases. * Significantly impaired renal function. * Current hypo- or hypercalcemia. * Positive for HIV, hepatitis C virus, or hepatitis B surface antigen. * Malignancy within the last 5 years. * Diagnosis of a familial cancer syndrome or known genetic mutation that increases risk of cancer. * Myocardial infarction or stroke within the past 12 months. * Use of agents affecting bone metabolism.

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Conditions

The condition(s) this trial relates to.

osteoporosis postmenopausal osteoporosis

As listed by the trial registrant

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

Postmenopausal osteoporosis

Contacts and locations

Locations

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635, United States

  • CE "Hospital #1" of Zhytomyr City Council

    Kyiv, Ukraine, Ukraine

  • CIDIIM

    Córdoba, Argentina

  • Center for Advanced Research & Education

    Gainesville, Georgia, 30501, United States

  • Centro Médico Dra Laura Maffei e Investigación Cliínica Aplicada

    Buenos Aires, Argentina, Argentina

  • Centro de Investigaciones Medicas Mar del Plata CIM

    Mar del Plata, Argentina

  • Consultorio de Investigacion Clinica EMO SRL

    Buenos Aires, Argentina, Argentina

  • Futuremeds Gdynia

    Gdynia, 81-384, Poland

  • Futuremeds Lodz

    Lodz, 91-363, Poland

  • Futuremeds Targowek

    Warsaw, 03-291, Poland

  • Futuremeds Warszawa Centrum

    Warsaw, 00-215, Poland

  • Futuremeds Wroclaw

    Wroclaw, 53-673, Poland

  • IDIM

    Buenos Aires, Argentina, Argentina

  • Instituto Médico Strusberg

    Córdoba, Argentina, Argentina

  • Investigaciones Reumatologicas y Osteologicas SRL

    Buenos Aires, Argentina, Argentina

  • Krakowskie Centrum Medyczne

    Krakow, 31-501, Poland

  • Mautalen - Salud e Investigacion (Expertia S.A.)

    Buenos Aires, Argentina, Argentina

  • Medical Center Universal Clinic "Oberig" of "Kapytal" LCC

    Kyiv, Ukraine, Ukraine

  • NM Clinical Research & Osteoporosis Center, Inc.

    Albuquerque, New Mexico, 87160, United States

  • PSSE Medical Centre Pulse

    Vinnytsia, Ukraine, Ukraine

  • Puget Sound Osteoporosis Center

    Burien, Washington, 98166, United States

  • Stat Research

    Buenos Aires, Argentina, Argentina

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.