Osteoporosis in Primary Hyperparathyroidism

NCT ID: NCT04085419

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-08
• Study Completion Date: 2023-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

denosumab

denosumab 60 mg subcutaneously every 6 months

Group Type: ACTIVE_COMPARATOR

Denosumab 60 MG/ML Prefilled Syringe [Prolia]

Intervention Type: DRUG

denosumab 60 mg subcutaneously every 6 months

zoledronic acid

zoledronic acid 5 mg intravenously once a year

Group Type: ACTIVE_COMPARATOR

Zoledronic Acid

Intervention Type: DRUG

zoledronic acid 5 mg intravenously once a year

Interventions

Denosumab 60 MG/ML Prefilled Syringe [Prolia]

denosumab 60 mg subcutaneously every 6 months

Intervention Type: DRUG

Zoledronic Acid

zoledronic acid 5 mg intravenously once a year

Intervention Type: DRUG

Other Intervention Names

Xgeva; Aclasta

Eligibility Criteria

Inclusion Criteria

• Postmenopausal women (>12 months after last menstrual period) with primary hyperparathyroidism and with osteoporosis on Dual Energy Xray Absorptiometry (DXA) (according to International Society for Clinical Densitometry (ISCD) - criteria) and/or osteoporotic fracture of the vertebra or hip

Exclusion Criteria

• The patient is not able to give informed consent
• other classic complications of primary hyperparathyroidism (e.g. kidney stones, renal insufficiency)
• serum albumin-corrected calcium level > 2.85 mmol/L (except when the patient is reluctant to undergo surgical treatment)
• osteoporosis treatment less than a year ago, less than two years ago in the case of oral bisphosphonate, less than three years ago in the case of parenteral bisphosphonate
• bilateral hip endoprosthesis
• additional causes for secondary osteoporosis (other than vitamin D deficiency) and pathological laboratory findings that are incompatible with the Summary of Product Characteristics (SmPC) of both medicines
• cancer, except if in stable remission of more than 5 years

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Tomaz Kocjan

Professor Tomaz Kocjan, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomaz Kocjan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Ljubljana

Locations

Endocrinology Department

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

11111

Identifier Type: -

Identifier Source: org_study_id