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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2023-000007-39-DK

Enrollment

140

Registered

2023-02-01

Start date

2023-03-23

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Osteopenia i.e. bone mineral density T-score < -1 in patients with primary hyperparathyroidism MedDRA version: 20.0 Level: LLT Classification code 10005991 Term: Bone mass decreased System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Zoledronic acid Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Zoledronic acid CAS Number: 118072-93-8 Concentration unit: mg milligram(s) Concentration type: eq

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Postmenopausal females or males > 50 years b) A diagnosis of hyperparathyroid hypercalcemia due to sporadic PHPT referred to PTX c) BMD T-score = -1 at total hip, femoral neck, or lumbar spine d) 25-hydroxyvitamin D = 50 nmol/l prior to randomization e) Willingness to undergo PTX Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: a) Known or suspected familial ethology (e.g., MEN1 or 2) b) Estimated glomerular filtration rate < 35 ml/min c) Known allergy to bisphosphonates d) Planned or recent (within the last 3 months) major dental procedures e) Chronic or acute disorders (e.g., rheumatoid arthritis, inflammatory bowel disease, cancer) or medications (e.g., lithium, glucocorticoids within the last year, antiresorptive or bone anabolic treatment within the last 3 years) known to affect bone metabolism.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if zoledronic acid vs. place prior to parathyroidectomy improves bone mineral density;Secondary Objective: To investigate if zoledronic acid vs. placebo prior to parathyroidectomy improves bone microarchitecture ;Primary end point(s): Effects of bisphosphonates vs. placebo at time of parathyroidectomy on BMD at lumbar spine, femoral neck, and total hip on year after PTX. ;Timepoint(s) of evaluation of this end point: After 12 months	—

Measure

Time frame

Main Objective: To investigate if zoledronic acid vs. place prior to parathyroidectomy improves bone mineral density;Secondary Objective: To investigate if zoledronic acid vs. placebo prior to parathyroidectomy improves bone microarchitecture ;Primary end point(s): Effects of bisphosphonates vs. placebo at time of parathyroidectomy on BMD at lumbar spine, femoral neck, and total hip on year after PTX. ;Timepoint(s) of evaluation of this end point: After 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): II. Effects on BMD at distal forearm. III. Effects on microarchitecture measured by high-resolution peripheral computed tomography (HRpQCT). IV. Effects on biochemical bone turnover markers.;Timepoint(s) of evaluation of this end point: After 12 months	—

Countries

Denmark

Contacts

Public ContactKlinik for Knogleskørhed

Aarhus University Hospital, Department of Endocrinology and Internal Medicine

henrkn@rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026