Hyperparathyroidism, PrimaryPhase 3NCT00975221
Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy
A Phase 3 study testing Cinacalcet in people with Hyperparathyroidism, Primary and Hypercalcemia, run by Amgen at 47 sites in 7 countries.
Trial summary
This study is designed to demonstrate the efficacy and to assess the safety of cinacalcet for the reduction of hypercalcemia in patients with primary hyperparathyroidism for whom parathyroidectomy is indicated on the basis of an elevated corrected total serum calcium, but who are unable to undergo parathyroidectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperparathyroidism, Primary, Hypercalcemia
- What is being tested?
- Cinacalcet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 47 sitesin 7 countries
- Study dates
- 10 Mar 2010to 21 Dec 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- age ≥ 18 years
- diagnosis of primary hyperparathyroidism (HPT)
- subjects must have the following laboratory values:
- local/historical laboratory result showing a corrected total serum calcium > 1 mg/dL (0.25 mmol/L) above the upper limit of normal and
- ≤ 12.5 mg/dL (3.12 mmol/L) within the past 12 months, and
- local/historical laboratory result showing a plasma parathyroid horone (PTH) > 75% of upper limit of normal within the past 12 months, and
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- one central laboratory draw at the screen visit showing a corrected total serum calcium > 11.3 mg/dL (2.82 mmol/L) and ≤ 12.5 mg/dL (3.12 mmol/L), and
- one central laboratory draw at the screen visit showing a plasma PTH > 55 pg/mL (5.8 pmol/L) OR
- two central laboratory draws performed during the screening period at least 7 days apart, showing a
- corrected total serum calcium > 11.3 mg/dL (2.82 mmol/L) and ≤ 12.5 mg/dL (3.12 mmol/L), and
- plasma PTH > 55 pg/mL (5.8 pmol/L)
- not able to undergo parathyroidectomy for ≥ 1 of the following reasons:
- failed parathyroidectomy
- comorbid conditions contraindicating parathyroidectomy
- parathyroidectomy not considered appropriate or is not feasible by primary physician and subject
- before any study-specific procedure is performed, the appropriate written informed consent must be obtained
Who cannot join
- symptoms attributable to hypercalcemia, requiring immediate medical intervention, as judged by the investigator (including acute kidney stone, nausea and vomiting requiring intravenous hydration, confusion, lethargy, stupor, or coma)
- unstable medical condition, defined as having been hospitalized within 30 days before the date of informed consent, or otherwise unstable in the judgment of the investigator
- administration of drugs that increase serum calcium concentration, including but not limited to thiazide diuretics or lithium
- initiated bisphosphonate therapy or changed bisphosphonate dose within 12 weeks before the date of informed consent
- current administration of drugs for ventricular arrhythmia
- unable to provide informed consent, or is at risk for poor compliance with study procedures
Show all 13Show fewer
- currently enrolled in another investigational device or drug study(s), or completed such study within 30 days before the date of informed consent
- known hypersensitivity to or unable to tolerate cinacalcet
- received treatment with cinacalcet within 60 days before the date of informed consent
- history of seizures or an adjustment of anti-seizure medication within 12 weeks before the date of informed consent
- family history or diagnosis a genetic syndrome, such as familial benign hypocalciuric hypercalcemia (FBHH) or multiple endocrine neoplasia type 1 (MEN1) and type 2 (MEN2), where primary HPT is one of the clinical manifestations of familial benign hypocalciuric hypercalcemia (FBHH)
- refused to use highly effective contraceptive measures (as determined by the investigator) throughout the study
- pregnant or breastfeeding
Trial locations and contacts
47 sites in 7 countries.
47 sites in 7 countries
United States22 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Aurora, Colorado, 80045
Research Site
Aventura, Florida, 33180
Research Site
Clearwater, Florida, 33756
Research Site
Columbus, Ohio, 43210-1296
Research Site
Detroit, Michigan, 48236
Research Site
Indianapolis, Indiana, 46202
Research Site
Jacksonville, Florida, 32204
Research Site
Kenner, Louisiana, 70065
Research Site
Lake Forest, California, 92630
Research Site
Lancaster, California, 93534
Research Site
Los Gatos, California, 95032
Research Site
Miami, Florida, 33145
Research Site
Mission Viejo, California, 92691
Research Site
Morehead City, North Carolina, 28557
Research Site
New Orleans, Louisiana, 70121
Research Site
New York, New York, 10032
Research Site
Orange, California, 92869
Research Site
Pembroke Pines, Florida, 33028
Research Site
San Diego, California, 92124
Research Site
Washington D.C., District of Columbia, 20010
Research Site
Weston, Florida, 33331
Russia6 sites
Research Site
Moscow, 117036
Research Site
Moscow, 119034
Research Site
Moscow, 129110
Research Site
Rostov-na-Dony, 344022
Research Site
Saint Petersburg, 197341
Research Site
Yaroslavl, 150003
Australia5 sites
Research Site
Footscray, Victoria, 3011
Research Site
Geelong, Victoria, 3220
Research Site
Nedlands, Western Australia, 6009
Research Site
Randwick, New South Wales, 2031
Research Site
St Leonards, New South Wales, 2065
Canada4 sites
Research Site
Calgary, Alberta, T2N 4Z6
Research Site
London, Ontario, N6A 4V2
Research Site
Oakville, Ontario, L6J 1X8
Research Site
Toronto, Ontario, M5C 2T2
Hungary4 sites
Research Site
Budapest, 1083
Research Site
Budapest, 1088
Research Site
Budapest, 1113
Research Site
Szeged, 6720
Poland3 sites
Research Site
Warsaw, 01-809
Research Site
Warsaw, 02-097
Research Site
Warsaw, 02-507
Portugal3 sites
Research Site
Coimbra, 3000-075
Research Site
Lisbon, 1350-179
Research Site
Lisbon, 1649-035
About this study
Official title: A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Cinacalcet for the Treatment of Hypercalcemia in Subjects With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy
This study is designed to demonstrate the efficacy and to assess the safety of cinacalcet for the reduction of hypercalcemia in patients with primary hyperparathyroidism for whom parathyroidectomy is indicated on the basis of an elevated corrected total serum calcium, but who are unable to undergo parathyroidectomy.
Read the detailed description
The study will consist of a 30-day screening phase, a 12-week placebo-controlled dose-titration phase, and a 16-week placebo-controlled efficacy assessment phase (EAP). Participants who complete 28 weeks on study will continue into an open-label safety extension phase for 24 weeks of investigational cinacalcet treatment.
- Conditions
- Hyperparathyroidism, Primary, Hypercalcemia
- Being tested
- Cinacalcet, Placebo
- Keywords
- Primary hyperparathyroidism, Parathyroidectomy, Hypercalcemia
- Medical subject headings
- Hyperparathyroidism, Primary, Hypercalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinacalcetDrug
Also called Sensipar, Mimpara
Administered orally at a starting dose of 30 mg twice a day (BID). Participants will be eligible for a dose titration once every 3 weeks during the placebo-controlled dose titration phase based on corrected total serum calcium concentration and safety assessments obtained the previous week. Doses may be sequentially increased to 60 mg BID, 90 mg BID, and 90 mg 3 times a day (TID).
PlaceboDrug
Administered orally following the same tiitration regimen as the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Cinacalcet | Experimental | Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52. Receives: Drug: Cinacalcet |
| Placebo | Placebo comparator | Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52. Receives: Drug: Cinacalcet; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Mean Corrected Total Serum Calcium Concentration ≤ 10.3 mg/dL (2.57 mmol/L) During the EAP
Measured: Efficacy assessment phase (study visits at Weeks 16, 20, 24, and 28)
Secondary outcomes (3)
Percentage of Participants With a ≥ 1 mg/dL (0.25 mmol/L) Decrease From Baseline in Mean Corrected Total Serum Calcium Concentration During the EAP
Measured: Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)
Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP
Measured: Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)
Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP
Measured: Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study start10 Mar 2010
- Primary completion12 Jul 2012
- Study completion21 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperparathyroidism, PrimaryStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975221
- Sponsor's protocol ID
- 20070277
- Status last verified
- Sep 2018
- First submitted
- 10 Sep 2009
- Last updated
- 17 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Khan A, Bilezikian J, Bone H, Gurevich A, Lakatos P, Misiorowski W, Rozhinskaya L, Trotman ML, Toth M. Cinacalcet normalizes serum calcium in a double-blind randomized, placebo-controlled study in patients with primary hyperparathyroidism with contraindications to surgery. Eur J Endocrinol. 2015 May;172(5):527-35. doi: 10.1530/EJE-14-0877. Epub 2015 Jan 30.
PubMed 25637076
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Cinacalcet for the Treatment of Hypercalcemia in Subjects With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy
- ClinicalTrials.gov ID
- NCT00975221
- Acronym / sponsor ID
- 20070277
- Conditions
- Hyperparathyroidism, Primary, Hypercalcemia
- Keywords
- Primary hyperparathyroidism, Parathyroidectomy, Hypercalcemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2010 (actual)
- Primary completion
- 12 Jul 2012 (actual)
- Study completion
- 21 Dec 2012 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Posted 25 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to demonstrate the efficacy and to assess the safety of cinacalcet for the reduction of hypercalcemia in patients with primary hyperparathyroidism for whom parathyroidectomy is indicated on the basis of an elevated corrected total serum calcium, but who are unable to undergo parathyroidectomy.
Detailed description
The study will consist of a 30-day screening phase, a 12-week placebo-controlled dose-titration phase, and a 16-week placebo-controlled efficacy assessment phase (EAP). Participants who complete 28 weeks on study will continue into an open-label safety extension phase for 24 weeks of investigational cinacalcet treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinacalcet | Experimental | Drug: CinacalcetParticipants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52. |
| Placebo | Placebo comparator | Drug: Cinacalcet, Drug: PlaceboParticipants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- age ≥ 18 years
- diagnosis of primary hyperparathyroidism (HPT)
- subjects must have the following laboratory values:
- ≤ 12.5 mg/dL (3.12 mmol/L) within the past 12 months, and
- not able to undergo parathyroidectomy for ≥ 1 of the following reasons:
Key exclusion criteria (13 listed)
- symptoms attributable to hypercalcemia, requiring immediate medical intervention, as judged by the investigator (including acute kidney stone, nausea and vomiting requiring intravenous hydration, confusion, lethargy, stupor, or coma)
- unstable medical condition, defined as having been hospitalized within 30 days before the date of informed consent, or otherwise unstable in the judgment of the investigator
- administration of drugs that increase serum calcium concentration, including but not limited to thiazide diuretics or lithium
- initiated bisphosphonate therapy or changed bisphosphonate dose within 12 weeks before the date of informed consent
- current administration of drugs for ventricular arrhythmia
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 |
|---|---|---|
| CinacalcetAlso: Sensipar, MimparaAdministered orally at a starting dose of 30 mg twice a day (BID). Participants will be eligible for a dose titration once every 3 weeks during the placebo-controlled dose titration phase based on corrected total serum calcium concentration and safety assessments obtained the previous week. Doses may be sequentially increased to 60 mg BID, 90 mg BID, and 90 mg 3 times a day (TID). | Drug | Cinacalcet, Placebo |
| PlaceboAdministered orally following the same tiitration regimen as the experimental arm. | Drug | Placebo |
Primary outcome
Percentage of Participants With Mean Corrected Total Serum Calcium Concentration ≤ 10.3 mg/dL (2.57 mmol/L) During the EAP
Time frame: Efficacy assessment phase (study visits at Weeks 16, 20, 24, and 28)
3 secondary outcomes
Percentage of Participants With a ≥ 1 mg/dL (0.25 mmol/L) Decrease From Baseline in Mean Corrected Total Serum Calcium Concentration During the EAP
Time frame: Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)
Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP
Time frame: Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)
Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP
Time frame: Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25637076Khan A, Bilezikian J, Bone H, Gurevich A, Lakatos P, Misiorowski W, Rozhinskaya L, Trotman ML, Toth M. Cinacalcet normalizes serum calcium in a double-blind randomized, placebo-controlled study in patients with primary hyperparathyroidism with contraindications to surgery. Eur J Endocrinol. 2015 May;172(5):527-35. doi: 10.1530/EJE-14-0877. Epub 2015 Jan 30.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
47 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cinacalcet in people with Hyperparathyroidism, Primary and Hypercalcemia, run by Amgen at 47 sites in 7 countries.
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 16 inclusion and 13 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 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Russia, Australia, Canada, Hungary and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Mean Corrected Total Serum Calcium Concentration ≤ 10.3 mg/dL (2.57 mmol/L) During the EAP (time frame: Efficacy assessment phase (study visits at Weeks 16, 20, 24, and 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00975221, which also lists 1 linked publication.
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 17 Oct 2018.