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One shot or two? scientists test how the body handles osteoporosis drug

NCT ID NCT07811999

Knowledge-focused Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing whether romosozumab, a drug used to treat osteoporosis, reaches the bloodstream the same way when given as one larger injection or two smaller injections under the skin. The study enrolls healthy adults aged 18 to 60. Blood samples will measure drug levels over time, and researchers will track side effects and immune reactions.

What this could mean

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

Active substance
romosozumab, an osteoporosis drug given as an injection under the skin
What this could lead to
If the two injection methods deliver the drug similarly, it could give patients and doctors more flexibility in how romosozumab is given.
What could go wrong
This is an early-stage study in healthy volunteers, so it cannot show whether the drug works for patients. The two methods may not deliver the drug the same way, and side effects or immune reactions could occur.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 308 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

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

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 adults, male or female, 18 to 60 years of age. * Able and willing to provide written informed consent before any study procedures. * Body weight between 45.0 kg and 95.0 kg (inclusive). * Women must not be able to become pregnant (for example, postmenopausal or permanently sterile, as defined by the protocol). * Men who can father a child must agree to use the required contraception during the study and for 3 months after the study drug dose. * Willing and able to take daily calcium (500 to 2,000 mg elemental calcium) and vitamin D (at least 400 IU) supplements from Day 1 through the end of the study. Exclusion Criteria: * Any clinically significant medical condition or abnormal finding that, in the opinion of the study doctor, could make participation unsafe or interfere with the study or its results. * Clinically significant abnormalities on medical history, physical examination, vital signs, electrocardiogram (ECG), or laboratory tests, including suspected Gilbert syndrome. * History or current signs or symptoms of significant cardiovascular disease, including heart attack, heart failure, congenital heart disease, cardiomyopathy, valve disease, angina, coronary revascularization, stroke, transient ischemic attack, or peripheral revascularization. * Clinically significant abnormal heart rhythm or conduction disorder, including clinically significant ECG abnormalities. * QT interval corrected for heart rate (QTcF) greater than 450 milliseconds for men or greater than 470 milliseconds for women, or a history of long QT syndrome. * Second- or third-degree atrioventricular (AV) block. * Systolic blood pressure greater than 140 millimeters of mercury (mmHg) or less than 90 mmHg, diastolic blood pressure greater than 90 mmHg or less than 50 mmHg, or pulse rate greater than 100 beats per minute or less than 40 beats per minute at screening or check-in. * Deep vein thrombosis or pulmonary embolism within 3 months before screening. * History of osteoporosis, vertebral fracture, or a fragility fracture of the wrist, upper arm, hip, or pelvis after 50 years of age. * History of metabolic bone disease, including conditions such as Paget disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, sclerosteosis, ankylosing spondylitis, rheumatoid arthritis, Cushing disease, hyperprolactinemia, or malabsorption syndrome. * History of osteonecrosis of the jaw. * Bone fracture within 6 months before screening. * Vitamin D level below 20 nanograms per milliliter (ng/mL) at screening (participants may be treated and retested before enrollment). * Current hyperparathyroidism or hypoparathyroidism. * Kidney function below study requirements (estimated glomerular filtration rate less than 60 mL/min/1.73 m\^2). * Low or high blood calcium levels that do not meet study requirements. * Liver blood test results (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]) above the normal range. * History of hyperthyroidism or hypothyroidism unless on stable treatment for at least 6 months with normal thyroid function tests. * History of hearing loss caused by excessive bone growth compressing the eighth cranial nerve. * Positive test for human immunodeficiency virus (HIV). * Active hepatitis B or hepatitis C infection. * Cancer within the past 5 years, except non-melanoma skin cancer or cervical or breast ductal carcinoma in situ. * History of solid organ or bone marrow transplantation. * History of allergy or hypersensitivity to romosozumab, its ingredients, other biologic medicines, or medicines derived from mammalian cells. * Previous use of medications affecting bone metabolism that are not allowed by the protocol, including: * Any intravenous or oral bisphosphonate. * Fluoride for osteoporosis within 24 months before screening. * Denosumab or cathepsin K inhibitors within 18 months before screening. * Parathyroid hormone or strontium within 12 months before screening. * Calcitonin, selective estrogen receptor modulators, or tibolone within 3 months before screening. * Systemic corticosteroids (5 mg or more prednisone equivalent daily for more than 10 days) within 3 months before screening. * Use of prescription or over-the-counter medications within 30 days or 5 half-lives (whichever is longer) before check-in, unless approved by the study doctor. Acetaminophen up to 2 g/day is permitted. Stable hormone replacement therapy is allowed if unchanged for at least 3 months before dosing and throughout the study. * Use of herbal medicines, vitamins (other than study-required calcium and vitamin D), or dietary supplements within 30 days before enrollment unless approved by the study doctor. * Currently participating in another clinical study, receiving another investigational treatment, or participation in another investigational drug or device study within the previous 90 days or 5 half-lives (whichever is longer). * Previous participation in this study or previous exposure to a sclerostin antibody. * History of alcohol abuse or regular alcohol intake greater than 14 units per week within the year before check-in. * Alcohol use within 48 hours before check-in or unwillingness to comply with study alcohol restrictions. * Positive alcohol test at check-in. * Positive drug screen for illicit drugs, including cannabis, at screening or check-in. * History of illicit drug use within 6 months before screening. * Unwilling to avoid illicit drug use, including cannabis, throughout the study. * Smoking more than 10 cigarettes per day or equivalent nicotine use within 1 month before check-in, or unwillingness to comply with study tobacco restrictions. * Consumption of foods or drinks containing poppy seeds within 7 days before check-in. * Positive pregnancy test at screening or check-in. * Pregnant, breastfeeding, or planning to breastfeed during the study or within 3 months after receiving the study drug. * Receipt of blood products within 2 months before check-in. * Blood donation within 3 months before screening, plasma donation within 2 weeks before screening, or platelet donation within 6 weeks before screening. * Poor veins that would make repeated blood sampling difficult. * Any other reason that, in the opinion of the study doctor, would make participation unsafe or inappropriate.

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As listed by the trial registrant

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