Primary HyperparathyroidismPhase 4NCT01222026
Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate
A Phase 4 study testing Strontium Ranelate + Ca/Vitamin-D in people with Primary Hyperparathyroidism and Osteopenia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Patients with primary hyperparathyroidism (pHPT) with osteopenia and osteoporosis are treated with strontium ranelate/Ca+Vitamin-D or placebo/Ca+Vitamin D after successful surgical treatment of pHPT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperparathyroidism, Osteopenia, Osteoporosis
- What is being tested?
- Strontium Ranelate + Ca/Vitamin-D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2010to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- biochemically proven PHPT, PTX planned
- osteopenia (t-score < -1 and > -2.5) or osteoporosis (t-score ≤ -2.5) according to WHO Criteria [27]
Who cannot join
- Premenopausal women
- 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 hypocalciuric hypercalcaemia (Ca/creatinine ratio < 0.01)
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- Anamnestic pulmonal embolism or deep venous thrombosis
- Blood coagulation disorder or coagulopathy
- 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
- Known allergy against any component of the study medication
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Vienna, General Hospital Vienna (AKH Wien)
Vienna, State of Vienna, 1090
About this study
Official title: Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium- and Bone Metabolism After Successful Surgery? - Part I
Patients with primary hyperparathyroidism (pHPT) with osteopenia and osteoporosis are treated with strontium ranelate/Ca+Vitamin-D or placebo/Ca+Vitamin D after successful surgical treatment of pHPT.
Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD than placebo treated patients.
Read the detailed description
The chronic excessive hypersecretion of parathyroid hormone (PTH) has significant impact on bone remodeling. In primary hyperparathyroidism (PHPT) bone turnover is increased, resulting in a higher resorption of bone and thus loss of bone density.
After successful surgical treatment of pHPT bone metabolism switches from catabolic state to anabolic state again. However studies show that especially postmenopausal women regain significantly less BMD but these women suffer from osteopenia and osteoporosis most often and would need to regain as much bone mass as possible to prevent fractures. The optimal state would be to reach normal BMD again. Although this state is hardly reachable especially these patients may benefit from a treatment acting anti-resorptive and rising bone formation. The only drug combining these qualities known so far is Strontium ranelate.
Therefore the hypothesis is that Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD than placebo treated patients.
- Conditions
- Primary Hyperparathyroidism, Osteopenia, Osteoporosis
- Being tested
- Strontium Ranelate + Ca/Vitamin-D, Placebo
- Keywords
- Primary Hyperparathyroidism, Osteopenia, Osteoporosis
- Medical subject headings
- Hyperparathyroidism, Primary, Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strontium Ranelate + Ca/Vitamin-DDrug
Also called Protelos (r)
2g Strontium Ranelate once daily 1000mg Calcium 800 IE Vitamin D
PlaceboDrug
Placebo 1000mg Calcium 800 IE Vitamin-D
| Study group | Role | What they receive |
|---|---|---|
| Strontium Ranelate | Active comparator | Receiving Strontium Ranelate + Ca/Vitamin-D Receives: Drug: Strontium Ranelate + Ca/Vitamin-D |
| Placebo | Placebo comparator | Receiving Placebo + Ca/Vitamin D Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density measurement of the Lumbar spine
Measured: 1 year
Secondary outcomes (11)
Bone mineral density of the femoral neck
Measured: 1 year
Bone mineral density of the radius
Measured: 1 year
Osteoprotegerin (OPG/OCIF)
Measured: 1 year
RANKL (OPG-ligand)
Measured: 1 year
cathepsin K (cat K)
Measured: 1 year
ionised calcium (Ca++)
Measured: 1 year
phosphate (PO4-)
Measured: 1 year
alkaline phosphatase (AP)
Measured: 1 year
bone-specific alkaline phosphatase (BAP)
Measured: 1 year
osteocalcin (Oc)
Measured: 1 year
parathyroid hormone (PTH)
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 posted18 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2014
- Study completionDec 2014
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- National Bank of Austria
- Responsible party
- Principal investigator, Martin Niederle, Medical University of Vienna
- Investigators
- Bruno Niederle, Prof., MD, Principal investigator, Section of Endocrine Surgery, Department of Surgery, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222026
- Sponsor's protocol ID
- EK Nr 214/2008
- Other IDs
- 2008-001703-32, 2008
- Status last verified
- Jan 2015
- First submitted
- 15 Oct 2010
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. 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? - Part I
- ClinicalTrials.gov ID
- NCT01222026
- Acronym / sponsor ID
- EK Nr 214/2008
- Conditions
- Primary Hyperparathyroidism, Osteopenia, Osteoporosis
- Keywords
- Primary Hyperparathyroidism, Osteopenia, Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- National Bank of Austria
- Study start
- Sep 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Oct 2010 (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.
Patients with primary hyperparathyroidism (pHPT) with osteopenia and osteoporosis are treated with strontium ranelate/Ca+Vitamin-D or placebo/Ca+Vitamin D after successful surgical treatment of pHPT.
Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD than placebo treated patients.
Detailed description
The chronic excessive hypersecretion of parathyroid hormone (PTH) has significant impact on bone remodeling. In primary hyperparathyroidism (PHPT) bone turnover is increased, resulting in a higher resorption of bone and thus loss of bone density.
After successful surgical treatment of pHPT bone metabolism switches from catabolic state to anabolic state again. However studies show that especially postmenopausal women regain significantly less BMD but these women suffer from osteopenia and osteoporosis most often and would need to regain as much bone mass as possible to prevent fractures. The optimal state would be to reach normal BMD again. Although this state is hardly reachable especially these patients may benefit from a treatment acting anti-resorptive and rising bone formation. The only drug combining these qualities known so far is Strontium ranelate.
Therefore the hypothesis is that Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD than placebo treated patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strontium Ranelate | Active comparator | Drug: Strontium Ranelate + Ca/Vitamin-DReceiving Strontium Ranelate + Ca/Vitamin-D |
| Placebo | Placebo comparator | Drug: PlaceboReceiving Placebo + Ca/Vitamin D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- biochemically proven PHPT, PTX planned
- osteopenia (t-score < -1 and > -2.5) or osteoporosis (t-score ≤ -2.5) according to WHO Criteria [27]
Key exclusion criteria (16 listed)
- Premenopausal women
- 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 |
|---|---|---|
| Strontium Ranelate + Ca/Vitamin-DAlso: Protelos (r)2g Strontium Ranelate once daily 1000mg Calcium 800 IE Vitamin D | Drug | Strontium Ranelate |
| PlaceboPlacebo 1000mg Calcium 800 IE Vitamin-D | Drug | Placebo |
Primary outcome
Bone mineral density measurement of the Lumbar spine
Time frame: 1 year
11 secondary outcomes
Bone mineral density of the femoral neck
Time frame: 1 year
Bone mineral density of the radius
Time frame: 1 year
Osteoprotegerin (OPG/OCIF)
Time frame: 1 year
RANKL (OPG-ligand)
Time frame: 1 year
cathepsin K (cat K)
Time frame: 1 year
ionised calcium (Ca++)
Time frame: 1 year
phosphate (PO4-)
Time frame: 1 year
alkaline phosphatase (AP)
Time frame: 1 year
bone-specific alkaline phosphatase (BAP)
Time frame: 1 year
osteocalcin (Oc)
Time frame: 1 year
parathyroid hormone (PTH)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
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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
Section of Endocrine Surgery, Department of Surgery, Medical University of Vienna
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 Strontium Ranelate + Ca/Vitamin-D in people with Primary Hyperparathyroidism and Osteopenia, 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 2 inclusion and 16 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: finished, as of the sponsor's last update on 21 Jan 2015. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 measurement of the Lumbar spine (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 21 Jan 2015.