RECRUITING

Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover

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Conditions

Age-Related Osteoporosis

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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

Osteoporosis affects 24.5% of women over 65 and results in fracture-related hospital admissions exceeding those of heart attacks, strokes and breast cancer combined. Current treatment options do not account for differences between age-related and estrogen deficiency related osteoporosis, because of the need for bone biopsies for determination. This study will establish a paradigm-shifting individualized treatment protocol for age-related osteoporosis and a non-invasive method for its determination, thereby reducing the major health problems and enormous burden on society and the elderly related to this disease.

Official Title

Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover

Quick Facts

Study Start:2022-03-21
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05151484

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:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosed Osteoporosis by DXA (BMD t-score ≤ -2.5 with or without fragility fractures)
  2. 2. Treatment naive with respect to with anabolic or antiresorptive bone drugs.
  3. 3. Premenopausal, menopausal, and post-menopausal females.
  4. 4. 45 years old and older.
  5. 5. Presence or absence of diabetes
  6. 6. Normal levels of Vitamin D
  7. 7. Absence of all exclusion criteria on clinical workup
  1. 1. Pregnant or trying to become pregnant or are breastfeeding.
  2. 2. Participation in a study of an investigational drug during the past 30 days.
  3. 3. Treatment with anabolic or antiresorptive bone drugs.
  4. 4. Use of systemic anticoagulation (blood thinner)
  5. 5. Planned or anticipated oral surgery within the next 12 months.
  6. 6. Allergy to the antibiotics demeclocycline or tetracycline.
  7. 7. Planning to move out of the area within 18 months of the study.
  8. 8. Inability to stand or sit upright for at least 30 minutes.
  9. 9. Chronic alcoholism and/or drug addiction.
  10. 10. Prior radiation therapy (external beam or implant radiation) involving the skeleton (only if randomized to the bone forming drug (anabolic Forteo®)).
  11. 11. Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 Diabetes Mellitus).
  12. 12. Clinical condition that may limit study participation (e.g., heart diseases (unstable angina), lung diseases (severe COPD), other infections).
  13. 13. Abnormalities of the esophagus (tube connecting the mouth to the stomach) which delay esophageal emptying such as stricture (narrowing) or achalasia (a condition that prevents normal swallowing).
  14. 14. Have other bone diseases that are not linked to age or menopause.
  15. 15. Have a history of malignancy (cancer), not including non-melanoma skin cancer.
  16. 16. Vitamin D (Calcidiol) level below the normal range (below 20ng/mL).
  17. 17. AFTER RANDOMIZATION: If randomized to Group 1 Teriparatide and radius BMD t-score is less than -3.5 and does not sign consent to continue in the study.

Contacts and Locations

Study Contact

Hartmut H Malluche, MD
CONTACT
859-323-2637
hhmall@uky.edu
Paul F Netzel, DNP
CONTACT
859-323-2672
pfnetz2@uky.edu

Principal Investigator

hartmut h Mallluche, md
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40536
United States

Collaborators and Investigators

Sponsor: Hartmut Malluche, MD

  • hartmut h Mallluche, md, PRINCIPAL_INVESTIGATOR, University of Kentucky

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 Date2022-03-21
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2022-03-21
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Age-Related Osteoporosis