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Bisphosphonate vs. Placebo Prior to Parathyroidectomy in Primary Hyperparathyroidisme: A Randomized, blinded Placebo-controlled Trial

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520073-13-00
Acronym
2023-000007-39
Enrollment
140
Registered
2025-01-02
Start date
2025-03-02
Completion date
Unknown
Last updated
2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary hyperparathyroidism

Brief summary

Effects of ZOL vs. placebo at time of parathyroidectomy on aBMD at lumbar spine, one year after PTX.

Detailed description

Effects on aBMD at distal forearm, femoral neck, and total hip, Effects on microarchitecture measured by high-resolution peripheral computed tomography (HRpQCT), Effects on biochemical bone turnover markers (BTM)., Effects on vBMD at the hip and lumbar spine., Effects on CACS., Effects on PWV., Effects on renal calcifications and urinary analytes.

Interventions

DRUGZoledronic Acid Oresund Pharma 4 mg/100 ml infusionsvätska
DRUGlösning
DRUGNatriumklorid "Baxter" Clear-Flex 9 mg/ml
DRUGopløsning

Sponsors

Region Midtjylland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Effects of ZOL vs. placebo at time of parathyroidectomy on aBMD at lumbar spine, one year after PTX.

Secondary

MeasureTime frame
Effects on aBMD at distal forearm, femoral neck, and total hip, Effects on microarchitecture measured by high-resolution peripheral computed tomography (HRpQCT), Effects on biochemical bone turnover markers (BTM)., Effects on vBMD at the hip and lumbar spine., Effects on CACS., Effects on PWV., Effects on renal calcifications and urinary analytes.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026