Status:
ACTIVE_NOT_RECRUITING
A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)
Lead Sponsor:
Angitia Biopharmaceuticals
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
55-80 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density (BMD) in postmenopausal women with low bone mas...
Detailed Description
This Phase 2 dose-finding study will evaluate the safety, tolerability, and efficacy of AGA2118 at a range of dosing regimens in postmenopausal women with low BMD at the lumbar spine, total hip, or fe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2028
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT06577935
Start Date
October 31 2024
End Date
March 1 2028
Last Update
January 7 2026
Active Locations (27)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Center for Advanced Research & Education
Gainesville, Georgia, United States, 30501
3
NM Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, United States, 87160
4
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635