RECRUITING

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

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Age-Related Osteoporosis
Intervention / Treatment

-

Contacts and Locations

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40536

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Diagnosed Osteoporosis by DXA (BMD t-score ≤ -2.5 with or without fragility fractures)
  • 2. Treatment naive with respect to with anabolic or antiresorptive bone drugs.
  • 3. Premenopausal, menopausal, and post-menopausal females.
  • 4. 45 years old and older.
  • 5. Presence or absence of diabetes
  • 6. Normal levels of Vitamin D
  • 7. Absence of all exclusion criteria on clinical workup
  • 1. Pregnant or trying to become pregnant or are breastfeeding.
  • 2. Participation in a study of an investigational drug during the past 30 days.
  • 3. Treatment with anabolic or antiresorptive bone drugs.
  • 4. Use of systemic anticoagulation (blood thinner)
  • 5. Planned or anticipated oral surgery within the next 12 months.
  • 6. Allergy to the antibiotics demeclocycline or tetracycline.
  • 7. Planning to move out of the area within 18 months of the study.
  • 8. Inability to stand or sit upright for at least 30 minutes.
  • 9. Chronic alcoholism and/or drug addiction.
  • 10. Prior radiation therapy (external beam or implant radiation) involving the skeleton (only if randomized to the bone forming drug (anabolic Forteo®)).
  • 11. Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 Diabetes Mellitus).
  • 12. Clinical condition that may limit study participation (e.g., heart diseases (unstable angina), lung diseases (severe COPD), other infections).
  • 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. Have other bone diseases that are not linked to age or menopause.
  • 15. Have a history of malignancy (cancer), not including non-melanoma skin cancer.
  • 16. Vitamin D (Calcidiol) level below the normal range (below 20ng/mL).
  • 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.

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hartmut Malluche, MD,

hartmut h Mallluche, md, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

2026-08-31