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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00975221




Registration number
NCT00975221
Ethics application status
Date submitted
10/09/2009
Date registered
11/09/2009
Date last updated
17/10/2018

Titles & IDs
Public title
Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy
Scientific 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
Secondary ID [1] 0 0
20070277
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperparathyroidism, Primary 0 0
Hypercalcemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cinacalcet
Treatment: Drugs - Placebo

Experimental: Cinacalcet - 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.

Placebo comparator: Placebo - 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.


Treatment: Drugs: Cinacalcet
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).

Treatment: Drugs: Placebo
Administered orally following the same tiitration regimen as the experimental arm.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Mean Corrected Total Serum Calcium Concentration = 10.3 mg/dL (2.57 mmol/L) During the EAP
Timepoint [1] 0 0
Efficacy assessment phase (study visits at Weeks 16, 20, 24, and 28)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)
Secondary outcome [2] 0 0
Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP
Timepoint [2] 0 0
Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)
Secondary outcome [3] 0 0
Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP
Timepoint [3] 0 0
Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)

Eligibility
Key inclusion criteria
* age = 18 years
* diagnosis of primary hyperparathyroidism (HPT)
* subjects must have the following laboratory values:

1. 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
* 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
2. 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/12/2012
Sample size
Target
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Randwick
Recruitment hospital [2] 0 0
Research Site - St Leonards
Recruitment hospital [3] 0 0
Research Site - Footscray
Recruitment hospital [4] 0 0
Research Site - Geelong
Recruitment hospital [5] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Hungary
State/province [14] 0 0
Budapest
Country [15] 0 0
Hungary
State/province [15] 0 0
Szeged
Country [16] 0 0
Poland
State/province [16] 0 0
Warszawa
Country [17] 0 0
Portugal
State/province [17] 0 0
Coimbra
Country [18] 0 0
Portugal
State/province [18] 0 0
Lisboa
Country [19] 0 0
Russian Federation
State/province [19] 0 0
Moscow
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Rostov-na-Dony
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Saint Petersburg
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Yaroslavl

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00975221