Trial · NCT02440581

Renal Osteodystrophy: An Individual Management Approach

NCT02440581, Not applicable, Completed, Hartmut Malluche, MD; results first posted 2023-01-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Renal Osteodystrophy: An Individual Management Approach. Trials, record NCT02440581. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02440581

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Trial

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

Title: Renal Osteodystrophy: An Individual Management Approach
NCT number: NCT02440581
Status: Completed
Phases: Not applicable
Enrollment: 141 participants, actual
Lead sponsor: Hartmut Malluche, MD
Conditions: Kidney Failure, Chronic
Interventions: Alendronate, Teriparatide, Cinacalcet
First posted: 2015-05-12
Last updated: 2023-01-05
Results first posted: 2023-01-05

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Change in Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip	One Year (at baseline and one year)	At one year the investigators will asses bone mass using QCT of the total hip and compare one year changes in bone mass between the treatment and control groups.
Secondary	Change in Coronary Artery Calcifications by Multiple Detector Computed Tomography (MDCT)	One year (at baseline and one year)	At one year the investigators will asses differences between the treatment and control groups in changes in Coronary Artery Calcifications by MDCT. 1 Yr. Change in Sqrt CAC Vol.
Secondary	Change in Serum Biochemical Bone Markers of Bone Activity - Parathyroid Hormone (PTH)	1 Year (at baseline and one year)	Bone markers of bone activity tracked over time for changes.1 Yr. Change in PTH
Secondary	Change in Serum Biochemical Bone Markers of Bone Activity - Bone-specific Alkaline Phosphatase (BSAP)	1 year (at baseline and one year)	Bone markers of bone activity tracked over time for changes.1 Yr. Change in BSAP
Secondary	Change in Serum Biochemical Bone Markers of Bone Activity - Fibroblast Growth Factor 23 (FGF23)	1 Year (at baseline and 1 year)	Bone markers of bone activity tracked over time for changes. 1 Yr. Change in FGF-23

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip	One Year (at baseline and one year)		g/cm^3	MEAN
SECONDARY	Change in Coronary Artery Calcifications by Multiple Detector Computed Tomography (MDCT)	One year (at baseline and one year)		Hounsfield Unit	MEAN
SECONDARY	Change in Serum Biochemical Bone Markers of Bone Activity - Parathyroid Hormone (PTH)	1 Year (at baseline and one year)	1 Yr. Change in PTH	pg/ml	MEAN
SECONDARY	Change in Serum Biochemical Bone Markers of Bone Activity - Bone-specific Alkaline Phosphatase (BSAP)	1 year (at baseline and one year)	1 Yr. Change in BSAP	pg/ml	MEAN
SECONDARY	Change in Serum Biochemical Bone Markers of Bone Activity - Fibroblast Growth Factor 23 (FGF23)	1 Year (at baseline and 1 year)		pg/ml	MEAN

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Value	Spread	Units
Change in Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip	Control, Low Turnover	-10.71	Standard Error 4.73	g/cm^3
Change in Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip	Treatment, Low Turnover	5.72	Standard Error 4.74	g/cm^3
Change in Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip	Control, High Turnover	-3.52	Standard Error 3.36	g/cm^3
Change in Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip	Treatment, High Turnover	.2	Standard Error 5.67	g/cm^3
Change in Coronary Artery Calcifications by Multiple Detector Computed Tomography (MDCT)	Control, Low Turnover	2.78	Standard Error 1.51	Hounsfield Unit
Change in Coronary Artery Calcifications by Multiple Detector Computed Tomography (MDCT)	Treatment, Low Turnover	4.48	Standard Error 1.83	Hounsfield Unit
Change in Coronary Artery Calcifications by Multiple Detector Computed Tomography (MDCT)	Control, High Turnover	4.97	Standard Error 1.89	Hounsfield Unit
Change in Coronary Artery Calcifications by Multiple Detector Computed Tomography (MDCT)	Treatment, High Turnover	3.47	Standard Error 1.28	Hounsfield Unit
Change in Serum Biochemical Bone Markers of Bone Activity - Parathyroid Hormone (PTH)	Control, Low Turnover	89	Standard Error 32.3	pg/ml
Change in Serum Biochemical Bone Markers of Bone Activity - Parathyroid Hormone (PTH)	Treatment, Low Turnover	379	Standard Error 118.6	pg/ml

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Control, Low Turnover	37
Overall Study	STARTED	Treatment, Low Turnover	24
Overall Study	STARTED	Control, High Turnover	50
Overall Study	STARTED	Treatment, High Turnover	30
Overall Study	COMPLETED	Control, Low Turnover	32
Overall Study	COMPLETED	Treatment, Low Turnover	13
Overall Study	COMPLETED	Control, High Turnover	37
Overall Study	COMPLETED	Treatment, High Turnover	16
Overall Study	NOT COMPLETED	Control, Low Turnover	5
Overall Study	NOT COMPLETED	Treatment, Low Turnover	11

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events808

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	Left leg contusion	Blood and lymphatic system disorders	Control, Low Turnover	1	37
other	Left leg contusion	Blood and lymphatic system disorders	Treatment, Low Turnover	0	24
other	Left leg contusion	Blood and lymphatic system disorders	Control, High Turnover	0	50
other	Left leg contusion	Blood and lymphatic system disorders	Treatment, High Turnover	0	30
other	Possible blood clot in leg	Blood and lymphatic system disorders	Control, Low Turnover	0	37
other	Possible blood clot in leg	Blood and lymphatic system disorders	Treatment, Low Turnover	0	24
other	Possible blood clot in leg	Blood and lymphatic system disorders	Control, High Turnover	0	50
other	Possible blood clot in leg	Blood and lymphatic system disorders	Treatment, High Turnover	1	30
other	Chest pain	Cardiac disorders	Control, Low Turnover	0	37
other	Chest pain	Cardiac disorders	Treatment, Low Turnover	1	24

1 to 10 of 808Source ClinicalTrials.gov

See all 808 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Control, Low Turnover	0	37
Total, all-cause mortality	Treatment, Low Turnover	0	24
Total, all-cause mortality	Control, High Turnover	7	50
Total, all-cause mortality	Treatment, High Turnover	5	30
Total, other adverse events	Control, Low Turnover	16	37
Total, other adverse events	Treatment, Low Turnover	16	24
Total, other adverse events	Control, High Turnover	19	50
Total, other adverse events	Treatment, High Turnover	17	30
Total, serious adverse events	Control, Low Turnover	16	37
Total, serious adverse events	Treatment, Low Turnover	10	24

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
34231877	DERIVED

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DK080770	Renal Osteodystrophy: A Fresh Approach	MALLUCHE, HARTMUT H	UNIVERSITY OF KENTUCKY	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2009 to 2019

Source NIH RePORTER

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/NCT02440581

GET https://conductscience.org/api/trials/v1/NCT02440581/events?page=2

API reference For AI assistants