Efficacy and Safety Study of Cinacalcet for the Treatment... | NCT00975221

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Drug: Cinacalcet Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cinacalcet	Drug	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).

Measure	Description	Time Frame
Percentage of Participants With Mean Corrected Total Serum Calcium Concentration ≤ 10.3 mg/dL (2.57 mmol/L) During the EAP		Efficacy assessment phase (study visits at Weeks 16, 20, 24, and 28)

Measure	Description	Time Frame
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		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

Eligibility Module

Eligibility Criteria

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

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

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Lake Forest	California	92630	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
25637076	Background	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.

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Mean Corrected Total Serum Calcium Concentration ≤ 10.3 mg/dL (2.57 mmol/L) During the EAP

Full analysis set (all participants randomized to treatment). For participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (last value carried forward (LVCF) imputation). Participants with only baseline information were counted as non-responders.

Posted

Number

percentage of participants

Efficacy assessment phase (study visits at Weeks 16, 20, 24, and 28)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00034 OG00133

Title

Denominators

Categories

Title	Measurements
	OG0000.0 OG00175.8

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		<0.001		Cochran-Mantel-Haenszel (CMH) statistic	39.866											Superiority or Other

Secondary

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

Posted

Number

percentage of participants

Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP

Full analysis set with at least 1 post-baseline measurement; for participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (LVCF imputation).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP

Posted

Least Squares Mean

Standard Error

percent change

Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)

ID	Title	Description
OG000	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.
OG001	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.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Double-blind Phase: 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.	4	34	15	34
EG001	Double-blind Phase: 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 double-blind dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the double-blind efficacy assessment phase.	3	33	25	33
EG002	Open-label Phase: Previous Placebo	Participants who received placebo during the double-blind phase (Weeks 1-28) then received cinacalcet at a starting dose of 30 mg BID for 24 weeks in the open-label extension phase. 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.	7	29	15	29
EG003	Open-label Phase: Previous Cinacalcet	Participants who received cinacalcet during the double-blind phase continued to receive cinacalcet at a starting dose of 30 mg BID for 24 weeks in the open-label extension phase. 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.	1	28	10	28

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery occlusion	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG0030 affected28 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected33 at risk EG0021 affected29 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0021 affected29 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0011 affected33 at risk EG0020 affected29 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0011 affected33 at risk EG0020 affected29 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0021 affected29 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0021 affected29 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0021 affected29 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0011 affected33 at risk EG0020 affected29 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0011 affected33 at risk EG0020 affected29 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0011 affected33 at risk EG0020 affected29 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0021 affected29 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0021 affected29 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0021 affected29 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected33 at risk EG0021 affected29 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vertigo	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected34 at risk EG0011 affected33 at risk EG0020 affected29 at risk EG0030 affected28 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0012 affected33 at risk EG0020 affected29 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected34 at risk EG0012 affected33 at risk EG0023 affected29 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 affected34 at risk EG0014 affected33 at risk EG0021 affected29 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0006 affected34 at risk EG0019 affected33 at risk EG0026 affected29 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected34 at risk EG0012 affected33 at risk EG0020 affected29 at risk EG003
Asthenia	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG003
Oedema peripheral	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0012 affected33 at risk EG0023 affected29 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected34 at risk EG0012 affected33 at risk EG0021 affected29 at risk EG003
Sinusitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0022 affected29 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 affected34 at risk EG0011 affected33 at risk EG0021 affected29 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected34 at risk EG0013 affected33 at risk EG0020 affected29 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0012 affected33 at risk EG0020 affected29 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0022 affected29 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0013 affected33 at risk EG0020 affected29 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected34 at risk EG0013 affected33 at risk EG0022 affected29 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected34 at risk EG0011 affected33 at risk EG0020 affected29 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0016 affected33 at risk EG0024 affected29 at risk EG003
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0012 affected33 at risk EG0020 affected29 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected34 at risk EG0013 affected33 at risk EG0020 affected29 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0012 affected33 at risk EG0021 affected29 at risk EG003
Dizziness	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected34 at risk EG0013 affected33 at risk EG0020 affected29 at risk EG003
Headache	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected34 at risk EG0014 affected33 at risk EG0022 affected29 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0021 affected29 at risk EG003
Tremor	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG003
Renal pain	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0012 affected33 at risk EG0020 affected29 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected34 at risk EG0012 affected33 at risk EG0020 affected29 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected34 at risk EG0011 affected33 at risk EG0020 affected29 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected34 at risk EG0012 affected33 at risk EG0020 affected29 at risk EG003
Hypertension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected34 at risk EG0011 affected33 at risk EG0022 affected29 at risk EG003

ID	Term
D049950	Hyperparathyroidism, Primary
D006934	Hypercalcemia

ID	Term
D006961	Hyperparathyroidism
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases
D002128	Calcium Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D014883	Water-Electrolyte Imbalance

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups