Trial · NCT00975221

Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy

NCT00975221, Phase 3, Completed, Amgen; results first posted 2016-01-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy. Trials, record NCT00975221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00975221

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy
NCT number: NCT00975221
Status: Completed
Phases: Phase 3
Enrollment: 67 participants, actual
Lead sponsor: Amgen
Conditions: Hyperparathyroidism, Primary, Hypercalcemia
Interventions: Cinacalcet, Placebo
First posted: 2009-09-11
Last updated: 2018-10-17
Results first posted: 2016-01-25

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	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)
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	Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)
Secondary	Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP	Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)
Secondary	Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP	Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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)	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.	percentage of participants	NUMBER
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	Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)	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.	percentage of participants	NUMBER
SECONDARY	Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP	Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)	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).	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP	Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)	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).	percent change	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants With Mean Corrected Total Serum Calcium Concentration ≤ 10.3 mg/dL (2.57 mmol/L) During the EAP	Placebo	0.0		percentage of participants
Percentage of Participants With Mean Corrected Total Serum Calcium Concentration ≤ 10.3 mg/dL (2.57 mmol/L) During the EAP	Cinacalcet	75.8		percentage of participants
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	Placebo	5.9		percentage of participants
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	Cinacalcet	84.8		percentage of participants
Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP	Placebo	-1.66	Standard Error 0.99	percent change
Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP	Cinacalcet	-15.21	Standard Error 1.00	percent change
Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP	Placebo	-1.01	Standard Error 4.05	percent change
Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP	Cinacalcet	-23.80	Standard Error 4.18	percent change

Source ClinicalTrials.gov

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Titration Phase (Weeks 1-12)	STARTED	Placebo	34
Titration Phase (Weeks 1-12)	STARTED	Cinacalcet	33
Titration Phase (Weeks 1-12)	Received Study Drug	Placebo	34
Titration Phase (Weeks 1-12)	Received Study Drug	Cinacalcet	33
Titration Phase (Weeks 1-12)	COMPLETED	Placebo	31
Titration Phase (Weeks 1-12)	COMPLETED	Cinacalcet	29
Titration Phase (Weeks 1-12)	NOT COMPLETED	Placebo	3
Titration Phase (Weeks 1-12)	NOT COMPLETED	Cinacalcet	4
Efficacy Assessment Phase (Weeks 13-28)	STARTED	Placebo	30
Efficacy Assessment Phase (Weeks 13-28)	STARTED	Cinacalcet	29

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events204

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Vertigo	Ear and labyrinth disorders	Double-blind Phase: Placebo	3	34
other	Vertigo	Ear and labyrinth disorders	Double-blind Phase: Cinacalcet	1	33
other	Vertigo	Ear and labyrinth disorders	Open-label Phase: Previous Placebo	0	29
other	Vertigo	Ear and labyrinth disorders	Open-label Phase: Previous Cinacalcet	0	28
other	Abdominal distension	Gastrointestinal disorders	Double-blind Phase: Placebo	0	34
other	Abdominal distension	Gastrointestinal disorders	Double-blind Phase: Cinacalcet	2	33
other	Abdominal distension	Gastrointestinal disorders	Open-label Phase: Previous Placebo	0	29
other	Abdominal distension	Gastrointestinal disorders	Open-label Phase: Previous Cinacalcet	0	28
other	Abdominal pain upper	Gastrointestinal disorders	Double-blind Phase: Placebo	2	34
other	Abdominal pain upper	Gastrointestinal disorders	Double-blind Phase: Cinacalcet	2	33

1 to 10 of 204Source ClinicalTrials.gov

See all 204 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Double-blind Phase: Placebo
Total, all-cause mortality	Double-blind Phase: Cinacalcet
Total, all-cause mortality	Open-label Phase: Previous Placebo
Total, all-cause mortality	Open-label Phase: Previous Cinacalcet
Total, other adverse events	Double-blind Phase: Placebo	15	34
Total, other adverse events	Double-blind Phase: Cinacalcet	25	33
Total, other adverse events	Open-label Phase: Previous Placebo	15	29
Total, other adverse events	Open-label Phase: Previous Cinacalcet	10	28
Total, serious adverse events	Double-blind Phase: Placebo	4	34
Total, serious adverse events	Double-blind Phase: Cinacalcet	3	33

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25637076	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00975221

GET https://conductscience.org/api/trials/v1/NCT00975221/events?page=2

API reference For AI assistants