Primary HyperparathyroidismPhase 2NCT00973336
Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Surgery?
A Phase 2 study testing Calcium and vitamin D in people with Primary Hyperparathyroidism and Bone Metabolism, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Primary Hyperparathyroidism (pHPT) increases bone turnover and resorption and thus calcium efflux out of bone. After successful surgical treatment of pHPT, bone takes up calcium again which may result in secondary hyperparathyroidism or even "hungry bone syndrome". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperparathyroidism, Bone Metabolism
- What is being tested?
- Calcium and vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2009to Sep 2017
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- Male patients
- Biochemically proven PHPT, PTX planned
- No evidence for osteoporosis
Who cannot join
- Postoperative hypocalcemia needing substitution with calcium and vitamin D/ 1-25-OH-Vitamin D
- Cancer (lung, breast, prostatic, parathyroid cancer and thyroid carcinoma >1cm)
- Persisting or recurrent PHPT (postoperative hypercalcemia)
- Four-gland hyperplasia
- Multiple endocrine neoplasia (MEN) or hereditary PHPT
- Familial hypercalciuric hypercalcaemia (Ca/creatinine ratio < 0.01)
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- Phenylketonuria
- Renal impairment (creatinine clearance <30ml/h)
- Severe hepatic disorder
- Severe systemic disorder
- Thyroid dysfunction
- Immobilisation
- Intake of drugs with potential effects on BMD like glucocorticoids, lithium, estrogen-replacement therapy, selective Estrogen-receptor modulators (sERMs), bisphosphonates in the last three months
- Intake of drugs containing digoxin or digitoxin
- Known allergy against any component of the study medication
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Philipp Riss, MD, +43140400 ext. 5621, philipp.riss@meduniwien.ac.at
Philipp Riss, MD
About this study
Official title: Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Successful Surgery in Patients Without Osteoporosis?
Primary Hyperparathyroidism (pHPT) increases bone turnover and resorption and thus calcium efflux out of bone. After successful surgical treatment of pHPT, bone takes up calcium again which may result in secondary hyperparathyroidism or even "hungry bone syndrome". Until today there are no studies about this problem helping to develop recommendations or guidelines how to prevent these symptoms.
Study hypothesis: Calcium and vitamin D intake after surgery for PHPT protects the bone by keeping PTH in the normal range (less secondary, reactive hyperparathyroidism), prevents hungry bone- syndrome and improve bone-turnover markers (osteoporosis protection).
- Conditions
- Primary Hyperparathyroidism, Bone Metabolism
- Being tested
- Calcium and vitamin D
- Keywords
- postoperative follow-up
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium and vitamin DDrug
1000mg calcium per day 800 IE vitamin D per day
| Study group | Role | What they receive |
|---|---|---|
| Calcium and vitamin D | Experimental | Intervention Receives: Drug: Calcium and vitamin D |
| No treatment (control) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parathyroid hormone
Measured: 1 year
Secondary outcomes (3)
BMD of lumbar spine, femoral neck and radius
Measured: 1 year
Adverse effects calcium or vitamin D
Measured: 1 year
Other biochemical markers of bone metabolism
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (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.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Riss, Medical University of Vienna
- Investigators
- Bruno Niederle, Prof., MD, Principal investigator, Medical University of Vienna, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973336
- Sponsor's protocol ID
- PHPT02_2008
- Status last verified
- Mar 2016
- First submitted
- 8 Sep 2009
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Successful Surgery in Patients Without Osteoporosis?
- ClinicalTrials.gov ID
- NCT00973336
- Acronym / sponsor ID
- PHPT02_2008
- Conditions
- Primary Hyperparathyroidism, Bone Metabolism
- Keywords
- postoperative follow-up
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 9 Sep 2009 (estimated)
- 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.
Primary Hyperparathyroidism (pHPT) increases bone turnover and resorption and thus calcium efflux out of bone. After successful surgical treatment of pHPT, bone takes up calcium again which may result in secondary hyperparathyroidism or even "hungry bone syndrome". Until today there are no studies about this problem helping to develop recommendations or guidelines how to prevent these symptoms.
Study hypothesis: Calcium and vitamin D intake after surgery for PHPT protects the bone by keeping PTH in the normal range (less secondary, reactive hyperparathyroidism), prevents hungry bone- syndrome and improve bone-turnover markers (osteoporosis protection).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium and vitamin D | Experimental | Drug: Calcium and vitamin DIntervention |
| No treatment (control) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women
- Male patients
- Biochemically proven PHPT, PTX planned
- No evidence for osteoporosis
Key exclusion criteria (15 listed)
- Postoperative hypocalcemia needing substitution with calcium and vitamin D/ 1-25-OH-Vitamin D
- Cancer (lung, breast, prostatic, parathyroid cancer and thyroid carcinoma >1cm)
- Persisting or recurrent PHPT (postoperative hypercalcemia)
- Four-gland hyperplasia
- Multiple endocrine neoplasia (MEN) or hereditary PHPT
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 |
|---|---|---|
| Calcium and vitamin D1000mg calcium per day 800 IE vitamin D per day | Drug | Calcium and vitamin D |
Primary outcome
Parathyroid hormone
Time frame: 1 year
3 secondary outcomes
BMD of lumbar spine, femoral neck and radius
Time frame: 1 year
Adverse effects calcium or vitamin D
Time frame: 1 year
Other biochemical markers of bone metabolism
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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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.
Bruno Niederle, Prof., MD principal investigator
Medical University of Vienna, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcium and vitamin D in people with Primary Hyperparathyroidism and Bone Metabolism, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 15 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 16 Mar 2016. 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 Austria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Philipp Riss, MD (+43140400 ext. 5621, philipp.riss@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parathyroid hormone (time frame: 1 year). 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 16 Mar 2016.