Study on the Effects of AGA2118 for Postmenopausal Women with Osteoporosis

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for Postmenopausal Osteoporosis, a condition where bones become weak and brittle due to hormonal changes after menopause. The treatment being tested is called AGA2118, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins designed to target specific substances in the body. In this study, AGA2118 is given as a solution for injection under the skin. Some participants will receive AGA2118, while others will receive a placebo, which looks like the treatment but does not contain the active substance.

The purpose of the study is to evaluate the safety, tolerability, and effectiveness of AGA2118 in increasing bone mineral density (BMD) in postmenopausal women with low bone mass. The study will last for about 12 months, during which participants will receive regular injections and have their bone density measured at different times. The main focus is on the change in BMD at the lumbar spine, which is the lower part of the back, after 12 months of treatment. Additionally, changes in BMD at other sites like the hip and forearm will also be monitored.

Participants will be monitored for any new bone fractures and other health changes throughout the study. The trial aims to find the most effective dose of AGA2118 and to ensure it is safe for use in treating postmenopausal osteoporosis. This research could lead to new treatment options for women with this condition, helping to improve their bone health and reduce the risk of fractures.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age and bone mineral density (BMD) criteria. Participants must be healthy, ambulatory, postmenopausal women aged between 55 and 80 years, with a BMD T-score between -2.5 and -3.5 at specific sites such as the lumbar spine, total hip, or femoral neck.

2 randomization

Participants are randomly assigned to receive either the investigational medication AGA2118 or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives which treatment.

3 treatment administration

The treatment involves a subcutaneous injection of either AGA2118 or placebo. The specific dosage and frequency of administration are determined by the study protocol, which aims to evaluate the safety, tolerability, and efficacy of the treatment over a 12-month period.

4 monitoring and follow-up

Participants undergo regular monitoring to assess changes in BMD at various sites, including the lumbar spine, total hip, femoral neck, and one-third distal radius. These assessments occur at baseline and at months 3, 6, and 12. Additionally, the incidence of new clinical fractures is monitored throughout the study.

5 final assessment

At the end of the 12-month period, a final assessment is conducted to determine the percent change in BMD from baseline. This helps evaluate the effectiveness of AGA2118 compared to the placebo.

Who Can Join the Study?

Participants must be postmenopausal women. This means women who have stopped having menstrual periods.
Participants should be between the ages of 55 and 80.
Participants must be healthy and able to walk without assistance.
Participants need to have a BMD T-score between -2.5 and -3.5. BMD stands for Bone Mineral Density, which measures the strength of bones. The T-score is a number that shows how much your bone density is higher or lower than the average.
Only women are eligible to participate in this study.

Who Cannot Join the Study?

Patients who are not postmenopausal women cannot participate.
Patients who do not have low BMD (Bone Mineral Density) cannot participate. BMD is a measure of the amount of minerals (like calcium) in your bones, which shows how strong they are.
Patients who are male cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who might need special protection, like children or people with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Krakowskie Centrum Medyczne Sp. z o.o.	Cracow	Poland
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Diagnostic Consultative Centre Ascendent OOD	Sofia	Bulgaria
Aalborg University Hospital	Aalborg	Denmark
University Multiprophy Hospital For Active Treatment – Plovdiv AD	Plovdiv	Bulgaria
East Tallinn Central Hospital	Tallin	Estonia
MediTrials OÜ	Tartu	Estonia
Center for Clinical and Basic Research AS	Tallin	Estonia
Asmvhu Uciproaztt Huedbvtg	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	10.01.2025
Denmark	Not recruiting	10.01.2025
Estonia	Not recruiting	10.01.2025
Poland	Not recruiting	10.01.2025

Trial locations

Investigated drugs:

AGA2118

AGA2118 is a medication being studied for its potential to improve bone mineral density in postmenopausal women who have low bone mineral density. The trial aims to assess how safe and well-tolerated this medication is, as well as how effective it is in increasing bone density in the spine over a period of 12 months.

Investigated diseases:

Osteoporosis postmenopausal

Postmenopausal Osteoporosis – This condition occurs in women after menopause, characterized by weakened bones due to a decrease in bone density. The reduction in estrogen levels after menopause accelerates bone loss, making bones more fragile and susceptible to fractures. It primarily affects the spine, hips, and wrists, leading to an increased risk of fractures even with minor falls or injuries. Over time, the condition can cause a decrease in height and a stooped posture due to vertebral fractures. The progression of the disease is gradual, often without symptoms until a fracture occurs. Regular monitoring of bone density can help in understanding the progression of this condition.

Trial ID:

2024-515610-41-00

Protocol code:

ACT23-001

NCT ID:

NCT06577935

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of AGA2118 for Postmenopausal Women with Osteoporosis

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