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Osteoporosis in Primary Hyperparathyroidism

Primary Purpose

Primary Hyperparathyroidism, Osteoporosis

Status
Enrolling by invitation
Phase
Phase 4
Locations
Slovenia
Study Type
Interventional
Intervention
Denosumab 60 MG/ML Prefilled Syringe [Prolia]
Zoledronic Acid
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hyperparathyroidism focused on measuring zoledronic acid, denosumab, primary hyperparathyroidism, osteoporosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Endocrinology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

denosumab

zoledronic acid

Arm Description

denosumab 60 mg subcutaneously every 6 months

zoledronic acid 5 mg intravenously once a year

Outcomes

Primary Outcome Measures

Bone mineral density after one year of treatment
Dual-energy X-ray absorptiometry (DXA)
CTX after 3 months of treatment
Unit of Measure: pmol/L
Corrected calcium after 3 months of treatment
Unit of Measure: mmol/L
Bone mineral density after two years of treatment
Dual-energy X-ray absorptiometry (DXA)
CTX after 12 months of treatment
Unit of Measure: pmol/L
CTX after 24 months of treatment
Unit of Measure: pmol/L
PINP after 3 months of treatment
Unit of Measure: µg/L
PINP after 12 months of treatment
Unit of Measure: µg/L
PINP after 24 months of treatment
Unit of Measure: µg/L
Bone-specific alkaline phosphatase (BAP) after 3 months of treatment
Unit of Measure: µg/L
Bone-specific alkaline phosphatase (BAP) after 12 months of treatment
Unit of Measure: µg/L
Bone-specific alkaline phosphatase (BAP) after 24 months of treatment
Unit of Measure: µg/L
Corrected calcium after 12 months of treatment
Unit of Measure: mmol/L
Corrected calcium after 24 months of treatment
Unit of Measure: mmol/L

Secondary Outcome Measures

Full Information

First Posted
September 2, 2019
Last Updated
November 2, 2022
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT04085419
Brief Title
Osteoporosis in Primary Hyperparathyroidism
Official Title
Management of Osteoporosis in Patients With Primary Hyperparathyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperparathyroidism, Osteoporosis
Keywords
zoledronic acid, denosumab, primary hyperparathyroidism, osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
denosumab
Arm Type
Active Comparator
Arm Description
denosumab 60 mg subcutaneously every 6 months
Arm Title
zoledronic acid
Arm Type
Active Comparator
Arm Description
zoledronic acid 5 mg intravenously once a year
Intervention Type
Drug
Intervention Name(s)
Denosumab 60 MG/ML Prefilled Syringe [Prolia]
Other Intervention Name(s)
Xgeva
Intervention Description
denosumab 60 mg subcutaneously every 6 months
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Other Intervention Name(s)
Aclasta
Intervention Description
zoledronic acid 5 mg intravenously once a year
Primary Outcome Measure Information:
Title
Bone mineral density after one year of treatment
Description
Dual-energy X-ray absorptiometry (DXA)
Time Frame
one year
Title
CTX after 3 months of treatment
Description
Unit of Measure: pmol/L
Time Frame
3 months
Title
Corrected calcium after 3 months of treatment
Description
Unit of Measure: mmol/L
Time Frame
3 months
Title
Bone mineral density after two years of treatment
Description
Dual-energy X-ray absorptiometry (DXA)
Time Frame
two years
Title
CTX after 12 months of treatment
Description
Unit of Measure: pmol/L
Time Frame
one year
Title
CTX after 24 months of treatment
Description
Unit of Measure: pmol/L
Time Frame
two years
Title
PINP after 3 months of treatment
Description
Unit of Measure: µg/L
Time Frame
3 months
Title
PINP after 12 months of treatment
Description
Unit of Measure: µg/L
Time Frame
one year
Title
PINP after 24 months of treatment
Description
Unit of Measure: µg/L
Time Frame
two years
Title
Bone-specific alkaline phosphatase (BAP) after 3 months of treatment
Description
Unit of Measure: µg/L
Time Frame
3 months
Title
Bone-specific alkaline phosphatase (BAP) after 12 months of treatment
Description
Unit of Measure: µg/L
Time Frame
one year
Title
Bone-specific alkaline phosphatase (BAP) after 24 months of treatment
Description
Unit of Measure: µg/L
Time Frame
two years
Title
Corrected calcium after 12 months of treatment
Description
Unit of Measure: mmol/L
Time Frame
one year
Title
Corrected calcium after 24 months of treatment
Description
Unit of Measure: mmol/L
Time Frame
two years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postmenopausal women
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomaz Kocjan, MD, PhD
Organizational Affiliation
UMC Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endocrinology Department
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Bone mineral density, bone turnover markers and basic laboratory results will be shared.
IPD Sharing Time Frame
The data will become available in 3 years. They will be available for 5 years.

Learn more about this trial

Osteoporosis in Primary Hyperparathyroidism

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