A Phase 4 interventional study of Denosumab 60 MG/ML Prefilled Syringe [Prolia] and Zoledronic Acid in Primary Hyperparathyroidism and Osteoporosis, sponsored by University Medical Centre Ljubljana. Status unknown at 1 site in Slovenia. Open to female participants. Per ClinicalTrials.gov, last updated 2022-11-04.
Sponsored by University Medical Centre Ljubljana · Phase 4, Interventional, and Treatment
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.
104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.
This study's planned enrollment of 40 is below the median of 68 across 60 interventional studies indexed under Hyperparathyroidism, Primary.
Browse Hyperparathyroidism, Primary studies →University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
denosumab 60 mg subcutaneously every 6 months
Drug: Denosumab 60 MG/ML Prefilled Syringe [Prolia]
zoledronic acid 5 mg intravenously once a year
Drug: Zoledronic Acid
Drug page: Denosumab
denosumab 60 mg subcutaneously every 6 months
Also known as: Xgeva
zoledronic acid 5 mg intravenously once a year
Also known as: Aclasta
Bone mineral density after one year of treatment
Dual-energy X-ray absorptiometry (DXA)
Time frame: one year
CTX after 3 months of treatment
Unit of Measure: pmol/L
Time frame: 3 months
Corrected calcium after 3 months of treatment
Unit of Measure: mmol/L
Time frame: 3 months
Bone mineral density after two years of treatment
Dual-energy X-ray absorptiometry (DXA)
Time frame: two years
CTX after 12 months of treatment
Unit of Measure: pmol/L
Time frame: one year
CTX after 24 months of treatment
Unit of Measure: pmol/L
Time frame: two years
PINP after 3 months of treatment
Unit of Measure: µg/L
Time frame: 3 months
PINP after 12 months of treatment
Unit of Measure: µg/L
Time frame: one year
PINP after 24 months of treatment
Unit of Measure: µg/L
Time frame: two years
Bone-specific alkaline phosphatase (BAP) after 3 months of treatment
Unit of Measure: µg/L
Time frame: 3 months
Bone-specific alkaline phosphatase (BAP) after 12 months of treatment
Unit of Measure: µg/L
Time frame: one year
Bone-specific alkaline phosphatase (BAP) after 24 months of treatment
Unit of Measure: µg/L
Time frame: two years
Corrected calcium after 12 months of treatment
Unit of Measure: mmol/L
Time frame: one year
Corrected calcium after 24 months of treatment
Unit of Measure: mmol/L
Time frame: two years
Plan to share: Yes — Bone mineral density, bone turnover markers and basic laboratory results will be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: The data will become available in 3 years. They will be available for 5 years.
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Denosumab · Zoledronic Acid
Hyperparathyroidism, Primary →
University Medical Centre Ljubljana →