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Osteoporosis in Primary Hyperparathyroidism

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ClinicalTrials.gov Identifier: NCT04085419
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Tomaz Kocjan, University Medical Centre Ljubljana

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
Primary Hyperparathyroidism Osteoporosis Drug: Denosumab 60 MG/ML Prefilled Syringe [Prolia] Drug: Zoledronic Acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022


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 Name: 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 Name: Aclasta




Primary Outcome Measures :
  1. Bone mineral density after one year of treatment [ Time Frame: one year ]
    Dual-energy X-ray absorptiometry (DXA)

  2. CTX after 3 months of treatment [ Time Frame: 3 months ]
    Unit of Measure: pmol/L

  3. Corrected calcium after 3 months of treatment [ Time Frame: 3 months ]
    Unit of Measure: mmol/L

  4. Bone mineral density after two years of treatment [ Time Frame: two years ]
    Dual-energy X-ray absorptiometry (DXA)

  5. CTX after 12 months of treatment [ Time Frame: one year ]
    Unit of Measure: pmol/L

  6. CTX after 24 months of treatment [ Time Frame: two years ]
    Unit of Measure: pmol/L

  7. PINP after 3 months of treatment [ Time Frame: 3 months ]
    Unit of Measure: µg/L

  8. PINP after 12 months of treatment [ Time Frame: one year ]
    Unit of Measure: µg/L

  9. PINP after 24 months of treatment [ Time Frame: two years ]
    Unit of Measure: µg/L

  10. Bone-specific alkaline phosphatase (BAP) after 3 months of treatment [ Time Frame: 3 months ]
    Unit of Measure: µg/L

  11. Bone-specific alkaline phosphatase (BAP) after 12 months of treatment [ Time Frame: one year ]
    Unit of Measure: µg/L

  12. Bone-specific alkaline phosphatase (BAP) after 24 months of treatment [ Time Frame: two years ]
    Unit of Measure: µg/L

  13. Corrected calcium after 12 months of treatment [ Time Frame: one year ]
    Unit of Measure: mmol/L

  14. Corrected calcium after 24 months of treatment [ Time Frame: two years ]
    Unit of Measure: mmol/L



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Postmenopausal women
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085419


Contacts
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Contact: Katarina Mlekus Kozamernik, MD +38631765865 katarina.mlekuskozamernik@kclj.si
Contact: Elizabeta Stepanovic, RN +38615224864 elizabeta.stepanovic@kclj.si

Locations
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Slovenia
Endocrinology Department Recruiting
Ljubljana, Slovenia, 1000
Contact: Elizabeta Stepanovic, RN    +38615224864    elizabeta.stepanovic@kclj.si   
Sub-Investigator: Mojca Jensterle Sever, MD, PhD         
Sub-Investigator: Antonela Sabati Rajic, MD         
Sub-Investigator: Kristina Groti Resman, MD, PhD         
Sub-Investigator: Matej Rakusa, MD         
Sub-Investigator: Vladimir Bozic, MD         
Sub-Investigator: Tina Krokter Kogoj, MD         
Sub-Investigator: Katarina Mlekus Kozamernik, MD         
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Tomaz Kocjan, MD, PhD UMC Ljubljana

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Responsible Party: Tomaz Kocjan, Professor Tomaz Kocjan, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT04085419     History of Changes
Other Study ID Numbers: 11111
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Bone mineral density, bone turnover markers and basic laboratory results will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The data will become available in 3 years. They will be available for 5 years.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tomaz Kocjan, University Medical Centre Ljubljana:
zoledronic acid
denosumab
primary hyperparathyroidism
osteoporosis
Additional relevant MeSH terms:
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Osteoporosis
Hyperparathyroidism
Hyperparathyroidism, Primary
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Parathyroid Diseases
Endocrine System Diseases
Zoledronic Acid
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs