Precision Medicine Approach for Osteoporosis - Follow Up Study

Enrolling by invitation · Phase 4

Conditions studied: Osteoporosis

In brief

Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality. Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781; efforts are focused on addressing this particular problem. Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment.

Key facts

Study ID: NCT06264609
Run by: Paul F Netzel
People needed: 40
Starts: 2024-02-01
Expected to finish: 2029-12-31
Last updated by the study team: 2026-04-01

Who can join

Age: 45 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Diagnosed Osteoporosis by DXA (BMD t-score = -2.5 with or without fragility fractures)
Prior enrollment and completion of therapy in the "Novel precision medicine approach to treatment of osteoporosis based on bone turnover" trial.3) Premenopausal, menopausal, and post-menopausal females.
45 years old and older.
Normal levels of Vitamin D
Absence of all exclusion criteria on clinical workup. Patients diagnosed as osteoporotic due to the presence of

You may not qualify if…

Pregnant or trying to become pregnant or are breastfeeding
Use of systemic anticoagulation (blood thinner)
Planned or anticipated oral surgery within the next 12 months
Planning to move out of the area within 18 months of the study
Inability to stand or sit upright for at least 30 minutes
Chronic alcoholism and/or drug addiction
Prior radiation therapy (external beam or implant radiation) involving the skeleton (only if randomized to the bone forming drug (anabolic Forteo®))
Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 diabetes mellitus)
Clinical condition that may limit study participation (e.g., heart diseases (unstable angina), lung diseases (severe COPD), other infections)
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)
Have other bone diseases that are not linked to age or menopause
Have a history of malignancy (cancer), not including non-melanoma skin cancer.
Vitamin D (Calcidiol) level below the normal range (below 20ng/mL).

Where it is running

University of Kentucky — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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