Primary HyperparathyroidismPhase 4NCT04085419
Osteoporosis in Primary Hyperparathyroidism
A Phase 4 study testing Denosumab 60 MG/ML Prefilled Syringe [Prolia] and Zoledronic Acid in people with Primary Hyperparathyroidism and Osteoporosis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Primary Hyperparathyroidism, Osteoporosis
- What is being tested?
- Denosumab 60 MG/ML Prefilled Syringe [Prolia] and Zoledronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 8 May 2019to May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Osteoporosis in Patients With Primary Hyperparathyroidism
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
- Being tested
- Denosumab 60 MG/ML Prefilled Syringe [Prolia], Zoledronic Acid
- Keywords
- zoledronic acid, denosumab, primary hyperparathyroidism, osteoporosis
- Medical subject headings
- Hyperparathyroidism, Primary, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab 60 MG/ML Prefilled Syringe [Prolia]Drug
Also called Xgeva
denosumab 60 mg subcutaneously every 6 months
Zoledronic AcidDrug
Also called Aclasta
zoledronic acid 5 mg intravenously once a year
| Study group | Role | What they receive |
|---|---|---|
| denosumab | Active comparator | denosumab 60 mg subcutaneously every 6 months Receives: Drug: Denosumab 60 MG/ML Prefilled Syringe [Prolia] |
| zoledronic acid | Active comparator | zoledronic acid 5 mg intravenously once a year Receives: Drug: Zoledronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density after one year of treatment
Dual-energy X-ray absorptiometry (DXA)
Measured: one year
CTX after 3 months of treatment
Unit of Measure: pmol/L
Measured: 3 months
Corrected calcium after 3 months of treatment
Unit of Measure: mmol/L
Measured: 3 months
Bone mineral density after two years of treatment
Dual-energy X-ray absorptiometry (DXA)
Measured: two years
CTX after 12 months of treatment
Unit of Measure: pmol/L
Measured: one year
CTX after 24 months of treatment
Unit of Measure: pmol/L
Measured: two years
PINP after 3 months of treatment
Unit of Measure: µg/L
Measured: 3 months
PINP after 12 months of treatment
Unit of Measure: µg/L
Measured: one year
PINP after 24 months of treatment
Unit of Measure: µg/L
Measured: two years
Bone-specific alkaline phosphatase (BAP) after 3 months of treatment
Unit of Measure: µg/L
Measured: 3 months
Bone-specific alkaline phosphatase (BAP) after 12 months of treatment
Unit of Measure: µg/L
Measured: one year
Bone-specific alkaline phosphatase (BAP) after 24 months of treatment
Unit of Measure: µg/L
Measured: two years
Corrected calcium after 12 months of treatment
Unit of Measure: mmol/L
Measured: one year
Corrected calcium after 24 months of treatment
Unit of Measure: mmol/L
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start8 May 2019
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomaz Kocjan, University Medical Centre Ljubljana
- Investigators
- Tomaz Kocjan, MD, PhD, Principal investigator, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085419
- Sponsor's protocol ID
- 11111
- Status last verified
- Nov 2022
- First submitted
- 2 Sep 2019
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Bone mineral density, bone turnover markers and basic laboratory results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Osteoporosis in Patients With Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT04085419
- Acronym / sponsor ID
- 11111
- Conditions
- Primary Hyperparathyroidism, Osteoporosis
- Keywords
- zoledronic acid, denosumab, primary hyperparathyroidism, osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| denosumab | Active comparator | Drug: Denosumab 60 MG/ML Prefilled Syringe [Prolia]denosumab 60 mg subcutaneously every 6 months |
| zoledronic acid | Active comparator | Drug: Zoledronic Acidzoledronic acid 5 mg intravenously once a year |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denosumab 60 MG/ML Prefilled Syringe [Prolia]Also: Xgevadenosumab 60 mg subcutaneously every 6 months | Drug | denosumab |
| Zoledronic AcidAlso: Aclastazoledronic acid 5 mg intravenously once a year | Drug | zoledronic acid |
Primary outcome
Bone mineral density after one year of treatment
Time frame: one year
Dual-energy X-ray absorptiometry (DXA)
CTX after 3 months of treatment
Time frame: 3 months
Unit of Measure: pmol/L
Corrected calcium after 3 months of treatment
Time frame: 3 months
Unit of Measure: mmol/L
Bone mineral density after two years of treatment
Time frame: two years
Dual-energy X-ray absorptiometry (DXA)
CTX after 12 months of treatment
Time frame: one year
Unit of Measure: pmol/L
CTX after 24 months of treatment
Time frame: two years
Unit of Measure: pmol/L
PINP after 3 months of treatment
Time frame: 3 months
Unit of Measure: µg/L
PINP after 12 months of treatment
Time frame: one year
Unit of Measure: µg/L
PINP after 24 months of treatment
Time frame: two years
Unit of Measure: µg/L
Bone-specific alkaline phosphatase (BAP) after 3 months of treatment
Time frame: 3 months
Unit of Measure: µg/L
Bone-specific alkaline phosphatase (BAP) after 12 months of treatment
Time frame: one year
Unit of Measure: µg/L
Bone-specific alkaline phosphatase (BAP) after 24 months of treatment
Time frame: two years
Unit of Measure: µg/L
Corrected calcium after 12 months of treatment
Time frame: one year
Unit of Measure: mmol/L
Corrected calcium after 24 months of treatment
Time frame: two years
Unit of Measure: mmol/L
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: Yes. Bone mineral density, bone turnover markers and basic laboratory results will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomaz Kocjan, MD, PhD principal investigator
UMC Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Denosumab 60 MG/ML Prefilled Syringe [Prolia] and Zoledronic Acid in people with Primary Hyperparathyroidism and Osteoporosis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density after one year of treatment (time frame: one year). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.