ACTIVE_NOT_RECRUITING

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

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Conditions

Postmenopausal OsteoporosisOsteoporosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Safety, Tolerability and Efficacy of AGA2118 in Postmenopausal Women With Low Bone Mineral Density

Quick Facts

Study Start:2024-10-31
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06577935

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 80 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy, ambulatory, postmenopausal women age ≥ 55 to ≤ 80.
  2. * BMD T-score of ≤ -2.5 to \> -3.5 at the lumbar spine, total hip, or femoral neck.
  1. * History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis.
  2. * Vitamin D deficiency.
  3. * Known intolerance to calcium or vitamin D supplements.
  4. * Untreated hyper- or hypothyroidism.
  5. * Current hyper- or hypoparathyroidism.
  6. * Elevated transaminases.
  7. * Significantly impaired renal function.
  8. * Current hypo- or hypercalcemia.
  9. * Positive for HIV, hepatitis C virus, or hepatitis B surface antigen.
  10. * Malignancy within the last 5 years.
  11. * Diagnosis of a familial cancer syndrome or known genetic mutation that increases risk of cancer.
  12. * Myocardial infarction or stroke within the past 12 months.
  13. * Use of agents affecting bone metabolism.

Contacts and Locations

Principal Investigator

Ricardo Dent-Acosta, MD
STUDY_DIRECTOR
Angitia Incorporated Limited

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501
United States
NM Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, 87160
United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
United States
Puget Sound Osteoporosis Center
Burien, Washington, 98166
United States

Collaborators and Investigators

Sponsor: Angitia Biopharmaceuticals

  • Ricardo Dent-Acosta, MD, STUDY_DIRECTOR, Angitia Incorporated Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-31
Study Completion Date2028-03

Study Record Updates

Study Start Date2024-10-31
Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

  • Osteoporosis

Additional Relevant MeSH Terms

  • Postmenopausal Osteoporosis