NCT03396315

Bisphosphonates for Prevention of Post-Denosumab Bone Loss

Bisphosphonates for Prevention of Post-Denosumab Bone Loss in Premenopausal Women With Idiopathic Osteoporosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 20 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Osteoporosis in premenopausal women with normal menstrual function and no specific cause is termed idiopathic osteoporosis (IOP). IOP is a rare disease with an estimated prevalence of \<200,000 affected premenopausal women in the United States. Women with IOP completing at least one year and up to three years of denosumab (Protocol AAAN0161) will be offered participation in this open-label study in which they would choose whether to take oral alendronate 70 mg weekly for 12 months or a single intravenous dose of zoledronic acid 5 mg. Subjects and study personnel will be blinded to BMD outcomes until 12 months. Discontinuation of denosumab is followed by substantial increases in bone turnover markers to well above baseline, bone resorption reaching twice baseline levels for about 6 months. Over the first 12 months off therapy, all the bone density gained on treatment is lost. Studies done at the institution has demonstrated the occurrence of multiple vertebral fractures in some patients who have stopped denosumab. Based upon these new fracture data, the Prolia label is currently recommending that consideration should be given to transition to another antiresorptive drug in patients stopping denosumab. The main goals of this extension study are to determine rates of bone loss and incidence of radiographic vertebral fractures during one year of bisphosphonate therapy (oral alendronate or intravenous zoledronic acid) initiated after completing denosumab.

Conditions

• IOP
• Osteoporosis

Interventions

Type	Name	Description
DRUG	Alendronate	oral alendronate 70 mg weekly for 12 months will be given for the prevention of osteoporosis
DRUG	Zoledronic Acid	single intravenous dose of zoledronic acid 5 mg will be given for the prevention of osteoporosis

Timeline

• Start date: 2018-01-29
• Primary completion: 2023-06-09
• Completion: 2023-06-09
• First posted: 2018-01-10
• Last updated: 2024-05-08
• Results posted: 2024-05-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study