Clinical Trials in Poland / NCT06577935
Active, not recruiting
Phase 2
A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)
NCT06577935 · tracked via the Priya Life Science Poland tracker
Condition(s) studied
Postmenopausal Osteoporosis
Investigational drug(s) / intervention(s)
AGA2118Placebo
AGA2118: Subcutaneous injection
Placebo: Subcutaneous injection
Study 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 mass.
Eligibility
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.
Primary outcome measure(s)
- Percent change from Baseline to Month 12 in lumbar spine bone mineral density — 12 months
To determine the effect of treatment with AGA2118 versus placebo at Month 12 on the percent change from Baseline in bone mineral density at the lumbar spine in postmenopausal women with low bone mineral density
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| Center for Advanced Research & Education | Gainesville | Georgia | |
| NM Clinical Research & Osteoporosis Center, Inc. | Albuquerque | New Mexico | |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | |
| Puget Sound Osteoporosis Center | Burien | Washington | |
| Centro Médico Dra Laura Maffei e Investigación Cliínica Aplicada | Buenos Aires | Argentina | |
| Consultorio de Investigacion Clinica EMO SRL | Buenos Aires | Argentina | |
| IDIM | Buenos Aires | Argentina | |
| Investigaciones Reumatologicas y Osteologicas SRL | Buenos Aires | Argentina | |
| Mautalen - Salud e Investigacion (Expertia S.A.) | Buenos Aires | Argentina | |
| Stat Research | Buenos Aires | Argentina | |
| Instituto Médico Strusberg | Córdoba | 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 | |
| Medical Center Universal Clinic "Oberig" of "Kapytal" LCC | Kyiv | Ukraine | |
| PSSE Medical Centre Pulse | Vinnytsia | Ukraine |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06577935 on ClinicalTrials.gov ↗ ← All trials in Poland