Trial · NCT03027557

Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet.

NCT03027557, Phase 3, Completed, Peter Vestergaard; results first posted 2021-05-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet. Trials, record NCT03027557. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03027557

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Trial

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

Title: Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet.
NCT number: NCT03027557
Status: Completed
Phases: Phase 3
Enrollment: 46 participants, actual
Lead sponsor: Peter Vestergaard
Conditions: Primary Hyperparathyroidism, Parathyroid Adenoma, Parathyroid Hyperplasia
Interventions: Cinacalcet 30 mg Tablet, Denosumab Inj 60 mg/ml, Placebo tablets, Saline Injection (Placebo)
First posted: 2017-01-23
Last updated: 2021-05-25
Other registries' IDs: eudract:2016-001510-20
Results first posted: 2021-05-25
Limitations and caveats: Important limitations are the relatively small number of study-participants, and the lack of a cinacalcet monotherapy-arm.

Source ClinicalTrials.gov

Registered outcomes35

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

List	Outcome	Time frame	Description
Primary	Change in Lumbar Spine Bone Mineral Density	Baseline,one year	Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.
Primary	Change in Total Hip Bone Mineral Density	Baseline,one year	Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.
Primary	Change in Femoral Neck Bone Mineral Density	Baseline,one year	Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.
Primary	Change in 1/3 Forearm Bone Mineral Density	Baseline,one year	Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.
Primary	Percentage Change in Lumbar Spine Bone Mineral Density	Baseline,one year	Percentage change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.
Primary	Percentage Change in Total Hip Bone Mineral Density	Baseline,one year	Percentage change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.
Primary	Percentage Change in Femoral Neck Bone Mineral Density	Baseline,one year	Percentage change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.
Primary	Percentage Change in 1/3 Forearm Bone Mineral Density	Baseline,one year	Percentage change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.
Secondary	Change in Volumetric BMD for the Lumbar Spine.	Baseline, one year	Measured at baseline and after one year by QCT.
Secondary	Mean P-calcium During Treatment.	Monthly up to one year.	Blood samples were acquired once every 4 weeks for safety-purposes.

1 to 10 of 35Source ClinicalTrials.gov

See all 35 registered outcomes

Outcomes35

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Lumbar Spine Bone Mineral Density	Baseline,one year	One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan.	g/cm^2	MEAN
PRIMARY	Change in Total Hip Bone Mineral Density	Baseline,one year	One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the placebo group did not provide results for this analysis as he/she had had a hip-replacement performed.	g/cm^2	MEAN
PRIMARY	Change in Femoral Neck Bone Mineral Density	Baseline,one year	One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the placebo group did not provide results for this analysis as he/she had had a hip-replacement performed.	g/cm^2	MEAN
PRIMARY	Change in 1/3 Forearm Bone Mineral Density	Baseline,one year	One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the denosumab group did not provide results for this analysis as he/she experienced a wrist fracture prior to the final scan.	g/cm^2	MEAN
PRIMARY	Percentage Change in Lumbar Spine Bone Mineral Density	Baseline,one year	One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan.	% change	MEAN
PRIMARY	Percentage Change in Total Hip Bone Mineral Density	Baseline,one year	One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the placebo group did not provide results for this analysis as he/she had had a hip-replacement performed.	% change	MEAN
PRIMARY	Percentage Change in Femoral Neck Bone Mineral Density	Baseline,one year	One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the placebo group did not provide results for this analysis as he/she had had a hip-replacement performed.	% change	MEAN
PRIMARY	Percentage Change in 1/3 Forearm Bone Mineral Density	Baseline,one year	One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the denosumab group did not provide results for this analysis as he/she experienced a wrist fracture prior to the final scan.	% change	MEAN
SECONDARY	Change in Volumetric BMD for the Lumbar Spine.	Baseline, one year	One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. Another scan could not be included due to a technical problems with the image analysis.	mg/cm^3	MEAN
SECONDARY	Mean P-calcium During Treatment.	Monthly up to one year.		mmol/l	MEAN

1 to 10 of 35Source ClinicalTrials.gov

See all 35 outcomes

Results by group93

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

Outcome	Group	Value	Spread	Units
Change in Lumbar Spine Bone Mineral Density	Combined Treatment.	0.030	Standard Error 0.009	g/cm^2
Change in Lumbar Spine Bone Mineral Density	Denosumab Monotherapy	0.042	Standard Error 0.009	g/cm^2
Change in Lumbar Spine Bone Mineral Density	Placebo	-0.016	Standard Error 0.007	g/cm^2
Change in Total Hip Bone Mineral Density	Combined Treatment.	0.027	Standard Error 0.006	g/cm^2
Change in Total Hip Bone Mineral Density	Denosumab Monotherapy	0.021	Standard Error 0.003	g/cm^2
Change in Total Hip Bone Mineral Density	Placebo	-0.013	Standard Error 0.006	g/cm^2
Change in Femoral Neck Bone Mineral Density	Combined Treatment.	0.023	Standard Error 0.006	g/cm^2
Change in Femoral Neck Bone Mineral Density	Denosumab Monotherapy	0.020	Standard Error 0.005	g/cm^2
Change in Femoral Neck Bone Mineral Density	Placebo	-0.007	Standard Error 0.006	g/cm^2
Change in 1/3 Forearm Bone Mineral Density	Combined Treatment.	0.005	Standard Error 0.003	g/cm^2

1 to 10 of 93Source ClinicalTrials.gov

See all 93 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Combined Treatment.	15
Overall Study	STARTED	Denosumab Monotherapy	16
Overall Study	STARTED	Placebo	15
Overall Study	COMPLETED	Combined Treatment.	14
Overall Study	COMPLETED	Denosumab Monotherapy	16
Overall Study	COMPLETED	Placebo	15
Overall Study	NOT COMPLETED	Combined Treatment.	1
Overall Study	NOT COMPLETED	Denosumab Monotherapy	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events66

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	Events
other	Leg edema	Skin and subcutaneous tissue disorders	Combined Treatment.	1	15	1
other	Leg edema	Skin and subcutaneous tissue disorders	Denosumab Monotherapy	2	16	7
other	Leg edema	Skin and subcutaneous tissue disorders	Placebo	0	15	0
other	Coughing	Respiratory, thoracic and mediastinal disorders	Combined Treatment.	1	15	1
other	Coughing	Respiratory, thoracic and mediastinal disorders	Denosumab Monotherapy	4	16	9
other	Coughing	Respiratory, thoracic and mediastinal disorders	Placebo	2	15	2
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Combined Treatment.	2	15	2
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Denosumab Monotherapy	2	16	6
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Placebo	0	15	0
other	Paraesthesia, hands	Nervous system disorders	Combined Treatment.	6	15	36

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Combined Treatment.	0	15
Total, all-cause mortality	Denosumab Monotherapy	0	16
Total, all-cause mortality	Placebo	0	15
Total, other adverse events	Combined Treatment.	13	15
Total, other adverse events	Denosumab Monotherapy	15	16
Total, other adverse events	Placebo	15	15
Total, serious adverse events	Combined Treatment.	2	15
Total, serious adverse events	Denosumab Monotherapy	1	16
Total, serious adverse events	Placebo	3	15

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32333877	DERIVED

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/NCT03027557

GET https://conductscience.org/api/trials/v1/NCT03027557/registered?page=2

API reference For AI assistants