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A Phase 2 Randomized Trial Evaluating Efficacy of AGA2118 in Postmenopausal Women with Low Bone Mass (ARTEMIS)
EU CTIS ID: 2024-515610-41-00
What this study is testing
To determine the effect of treatment with AGA2118 versus placebo at Month 12 on the percent change from Baseline in BMD at the lumbar spine in postmenopausal women with low BMD
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis
- Current hypo- or hypercalcemia
- Positive for HIV, hepatitis C virus, or hepatitis B surface antigen
- Diagnosis of a familial cancer syndrome or known genetic mutation that increases risk of cancer
- Myocardial infarction or stroke within the past 12 months
- Malignancy within the last 5 years
See the full eligibility 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
- History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis
- Current hypo- or hypercalcemia
- Positive for HIV, hepatitis C virus, or hepatitis B surface antigen
- Diagnosis of a familial cancer syndrome or known genetic mutation that increases risk of cancer
- Myocardial infarction or stroke within the past 12 months
- Malignancy within the last 5 years
- Use of agents affecting bone metabolism
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- Ukraine
- United States
- Argentina
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; Ukraine; United States; Argentina; Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.