NCT04085419

Osteoporosis in Primary Hyperparathyroidism

Management of Osteoporosis in Patients With Primary Hyperparathyroidism

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Investigators will prospectively include 40 postmenopausal women with secondary osteoporosis due to primary hyperparathyroidism who have refused surgery. Participants will be randomized in two groups and treated either with zoledronic acid 5 mg iv once a year or with denosumab 60 mg sc every 6 months. Investigators will compare the effect of both drugs on bone turnover markers and basic laboratory parameters after 3, 12 and 24 months of treatment, and on the bone mineral density after 12 and 24 months of treatment. All participants will take cholecalciferol 800 - 1000 IU daily.

Conditions

• Primary Hyperparathyroidism
• Osteoporosis

Interventions

Type	Name	Description
DRUG	Denosumab 60 MG/ML Prefilled Syringe [Prolia]	denosumab 60 mg subcutaneously every 6 months
DRUG	Zoledronic Acid	zoledronic acid 5 mg intravenously once a year

Timeline

• Start date: 2019-05-08
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2019-09-11
• Last updated: 2022-11-04

Locations

1 site across 1 country: Slovenia