Precision Medicine Approach for Osteoporosis - Follow Up Study - Trial NCT06264609

Timeline & Enrollment

Primary Outcome

Percent change in bone loss

Summary

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.

ICD-10 Classifications