A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Postmenopausal Osteoporosis
In brief
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 mass.
Key facts
- Study ID
- NCT06577935
- Run by
- Angitia Biopharmaceuticals
- People needed
- 379
- Starts
- 2024-10-31
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-02-10
Who can join
Age: 55 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify 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 may not qualify if…
- 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.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Center for Advanced Research & Education — Gainesville, Georgia, United States
- NM Clinical Research & Osteoporosis Center, Inc. — Albuquerque, New Mexico, United States
- Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
- Puget Sound Osteoporosis Center — Burien, Washington, United States
- Centro Médico Dra Laura Maffei e Investigación Cliínica Aplicada — Buenos Aires, Argentina, Argentina
- Consultorio de Investigacion Clinica EMO SRL — Buenos Aires, Argentina, Argentina
- IDIM — Buenos Aires, Argentina, Argentina
- Investigaciones Reumatologicas y Osteologicas SRL — Buenos Aires, Argentina, Argentina
- Mautalen - Salud e Investigacion (Expertia S.A.) — Buenos Aires, Argentina, Argentina
- Stat Research — Buenos Aires, Argentina, Argentina
- Instituto Médico Strusberg — Córdoba, Argentina, Argentina
- CIDIIM — Córdoba, Argentina
- Centro de Investigaciones Medicas Mar del Plata CIM — Mar del Plata, Argentina
- Futuremeds Gdynia — Gdynia, Poland
- Krakowskie Centrum Medyczne — Krakow, Poland
- Futuremeds Lodz — Lodz, Poland
- Futuremeds Warszawa Centrum — Warsaw, Poland
- Futuremeds Targowek — Warsaw, Poland
- Futuremeds Wroclaw — Wroclaw, Poland
- CE "Hospital #1" of Zhytomyr City Council — Kyiv, Ukraine, Ukraine
- Medical Center Universal Clinic "Oberig" of "Kapytal" LCC — Kyiv, Ukraine, Ukraine
- PSSE Medical Centre Pulse — Vinnytsia, Ukraine, Ukraine
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.