Osteoporosis in Primary Hyperparathyroidism

NCT04085419 | Unknown Phase 4

• 1 other identifier: 11111
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

zoledronic acid; denosumab; primary hyperparathyroidism; osteoporosis

Outcome Measures

Primary Outcomes (14)

• Bone mineral density after one year of treatment

  Dual-energy X-ray absorptiometry (DXA)

  one year

• CTX after 3 months of treatment

  Unit of Measure: pmol/L

  3 months

• Corrected calcium after 3 months of treatment

  Unit of Measure: mmol/L

  3 months

• Bone mineral density after two years of treatment

  Dual-energy X-ray absorptiometry (DXA)

  two years

• CTX after 12 months of treatment

  Unit of Measure: pmol/L

  one year

• CTX after 24 months of treatment

  Unit of Measure: pmol/L

  two years

• PINP after 3 months of treatment

  Unit of Measure: µg/L

  3 months

• PINP after 12 months of treatment

  Unit of Measure: µg/L

  one year

• PINP after 24 months of treatment

  Unit of Measure: µg/L

  two years

• Bone-specific alkaline phosphatase (BAP) after 3 months of treatment

  Unit of Measure: µg/L

  3 months

• Bone-specific alkaline phosphatase (BAP) after 12 months of treatment

  Unit of Measure: µg/L

  one year

• Bone-specific alkaline phosphatase (BAP) after 24 months of treatment

  Unit of Measure: µg/L

  two years

• Corrected calcium after 12 months of treatment

  Unit of Measure: mmol/L

  one year

• Corrected calcium after 24 months of treatment

  Unit of Measure: mmol/L

  two years

Study Arms (2)

denosumab

ACTIVE COMPARATOR

denosumab 60 mg subcutaneously every 6 months

Drug: Denosumab 60 MG/ML Prefilled Syringe [Prolia]

zoledronic acid

ACTIVE COMPARATOR

zoledronic acid 5 mg intravenously once a year

Drug: Zoledronic Acid

Interventions

Denosumab 60 MG/ML Prefilled Syringe [Prolia] DRUG

denosumab 60 mg subcutaneously every 6 months

Also known as: Xgeva

denosumab

Zoledronic Acid DRUG

zoledronic acid 5 mg intravenously once a year

Also known as: Aclasta

zoledronic acid

Eligibility Criteria

• Gender Eligibility Details: Postmenopausal women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

Endocrinology Department

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary; Osteoporosis

Interventions

Denosumab; Zoledronic Acid

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tomaz Kocjan, MD, PhD

  UMC Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Tomaz Kocjan, MD, PhD

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 11, 2019
• Study Start: May 8, 2019
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become available in 3 years. They will be available for 5 years.

Locations

SL (1)