Romosozumab/Denosumab Study for Premenopausal IOP

The overarching goal of the research program is to define optimal treatment for premenopausal women with clinically significant fracture syndromes that require medical therapy. The investigators hypothesize that romosozumab will be associated with improvements in bone mass and microarchitecture in premenopausal women, and also that the responses and response rates will exceed those observed in premenopausal women treated with teriparatide. The investigators will test this hypothesis in this phase 2 study of 30 premenopausal women with idiopathic osteoporosis (IOP) who will receive 12M of romosozumab 210 mg monthly followed by 12M of denosumab 60 mg SC q6M. Aim 1 will define the within-group effects of this regimen. Aim 2 will compare results from participants treated with romosozumab-denosumab to the investigator's well-characterized historical controls treated with teriparatide followed by denosumab.

NCT Number	NCT04800367
Lead Sponsor	Columbia University Collaborators: Amgen
Conditions	Premenopausal Idiopathic Osteoporosis
Enrollment	30 participants
Start Date	2021-03-12
Primary Completion	2027-03 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2026-02-27