At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Bisphosphonates for Prevention of Post-Denosumab Bone Loss in Premenopausal Women With Idiopathic Osteoporosis
In Brief
A Phase 2 clinical trial evaluating Alendronate and Zoledronic Acid for IOP and Osteoporosis. Completed, enrolled 24 participants across 2 sites.
Detailed Summary
The primary goal of the study is to assess the extent to which bisphosphonate therapy will prevent decreases in bone mass that may occur after cessation of denosumab in premenopausal women with idiopathic osteoporosis (IOP) enrolled in AAAN0161 (FD05114) "Denosumab for the prevention of post-teriparatide bone loss in premenopausal women with idiopathic osteoporosis". In addition, the investigator will observe participants for a second year off bisphosphonate therapy to assess duration of response. The hypothesis is that bisphosphonate therapy with alendronate or zoledronic acid, initiated after recovery of bone remodeling activity, will prevent significant bone loss after discontinuing denosumab.
Study Details
Timeline
Interventions
oral alendronate 70 mg weekly for 12 months will be given for the prevention of osteoporosis
single intravenous dose of zoledronic acid 5 mg will be given for the prevention of osteoporosis