Clincosm LogoSign in Get a demo

Osteoporosis in Primary Hyperparathyroidism

Sponsor
University Medical Centre Ljubljana (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04085419
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
35.8
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Denosumab 60 MG/ML Prefilled Syringe [Prolia]
  • Drug: Zoledronic Acid
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Management of Osteoporosis in Patients With Primary Hyperparathyroidism
Actual Study Start Date :
May 8, 2019
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: denosumab

denosumab 60 mg subcutaneously every 6 months

Drug: Denosumab 60 MG/ML Prefilled Syringe [Prolia]
denosumab 60 mg subcutaneously every 6 months
Other Names:
  • Xgeva

    		•
    Active Comparator: zoledronic acid

    zoledronic acid 5 mg intravenously once a year

    Drug: Zoledronic Acid
    zoledronic acid 5 mg intravenously once a year
    Other Names:
  • Aclasta

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bone mineral density after one year of treatment [one year]

      Dual-energy X-ray absorptiometry (DXA)

    2. CTX after 3 months of treatment [3 months]

      Unit of Measure: pmol/L

    3. Corrected calcium after 3 months of treatment [3 months]

      Unit of Measure: mmol/L

    4. Bone mineral density after two years of treatment [two years]

      Dual-energy X-ray absorptiometry (DXA)

    5. CTX after 12 months of treatment [one year]

      Unit of Measure: pmol/L

    6. CTX after 24 months of treatment [two years]

      Unit of Measure: pmol/L

    7. PINP after 3 months of treatment [3 months]

      Unit of Measure: µg/L

    8. PINP after 12 months of treatment [one year]

      Unit of Measure: µg/L

    9. PINP after 24 months of treatment [two years]

      Unit of Measure: µg/L

    10. Bone-specific alkaline phosphatase (BAP) after 3 months of treatment [3 months]

      Unit of Measure: µg/L

    11. Bone-specific alkaline phosphatase (BAP) after 12 months of treatment [one year]

      Unit of Measure: µg/L

    12. Bone-specific alkaline phosphatase (BAP) after 24 months of treatment [two years]

      Unit of Measure: µg/L

    13. Corrected calcium after 12 months of treatment [one year]

      Unit of Measure: mmol/L

    14. Corrected calcium after 24 months of treatment [two years]

      Unit of Measure: mmol/L

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Endocrinology Department Ljubljana Slovenia 1000

    Sponsors and Collaborators

    • University Medical Centre Ljubljana

    Investigators

    • Principal Investigator: Tomaz Kocjan, MD, PhD, UMC Ljubljana

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tomaz Kocjan, Professor Tomaz Kocjan, MD, PhD, University Medical Centre Ljubljana
    ClinicalTrials.gov Identifier:
    NCT04085419
    Other Study ID Numbers:
    • 11111
    First Posted:
    Sep 11, 2019
    Last Update Posted:
    Nov 9, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tomaz Kocjan, Professor Tomaz Kocjan, MD, PhD, University Medical Centre Ljubljana
    zoledronic acid
    denosumab
    primary hyperparathyroidism
    osteoporosis
    Additional relevant MeSH terms:
    Osteoporosis
    Hyperparathyroidism
    Hyperparathyroidism, Primary
    Zoledronic Acid
    Denosumab

    Study Results

    No Results Posted as of Nov 9, 2020