A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)

Launched by ANGITIA BIOPHARMACEUTICALS · Aug 27, 2024

Keywords

ClinConnect Summary

The ARTEMIS trial is studying a new treatment called AGA2118 to see how well it works in improving bone health in postmenopausal women with low bone mass. Specifically, the researchers want to find out if this treatment can increase bone mineral density (BMD) in the lower back after 12 months, compared to a placebo, which is an inactive treatment. This trial is currently looking for healthy women aged between 55 and 80 who have a specific level of bone density that makes them at risk for osteoporosis, a condition that weakens bones.

To participate, women must not have a history of certain fractures, vitamin D deficiency, or other serious health issues like recent heart attacks or strokes. Participants will receive either the AGA2118 treatment or a placebo and will regularly check in to see how their bones are responding. This trial offers an opportunity for eligible women to potentially help improve their bone health while contributing to important medical research.

Gender

FEMALE

Eligibility criteria

• 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.