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Trial record 40 of 246 for:    cardiac CT OR CAT scan OR coronary artery scan | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Renal Osteodystrophy: An Individual Management Approach

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ClinicalTrials.gov Identifier: NCT02440581
Recruitment Status : Recruiting
First Posted : May 12, 2015
Last Update Posted : May 3, 2017
Sponsor:
Collaborators:
Wright State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Hartmut Malluche, MD, University of Kentucky

Brief Summary:

Renal osteodystrophy (ROD) represents the bone histologic abnormalities resulting from loss of renal function. It starts early during the loss of kidney function and is seen in virtually all chronic end stage kidney disease patients on dialysis (CKD-5D). A major component of ROD is bone loss leading to chronic kidney disease (CKD) associated osteoporosis. Debilitating hip fractures occur in patients with CKD at a rate 4.4 times higher than in the general population, with associated high costs, morbidity and an annual mortality of 64%. CKD osteoporosis is distinctly different from post-menopausal osteoporosis. Presently, no uniformly accepted CKD osteoporosis treatment protocol exists because of challenges related to racially specific bone turnover states. Therefore, most physicians are reluctant to treat this disorder despite the profound impact on health and quality of life, and its association with vascular calcifications. These vascular calcifications confer an increased risk for cardiovascular events which are the major cause of the over 20% annual mortality rate in CKD-5D patients.

The goal of the proposed controlled randomized study is to test the concept that CKD osteoporosis can be successfully treated when treatment is individualized by patients' turnover status. The study will demonstrate that reversal of bone loss can be achieved by increasing bone formation in low turnover patients, and by reducing bone resorption in normal or high turnover patients. A second aim of this study is to provide new information whether these treatments will also retard progression of vascular calcifications. Blood tests measuring FGF23, indicators of Wnt pathway activity, bone resorption and formation will be followed to understand potential mechanisms and to evaluate their usefulness for prediction of changes in bone mass and vascular calcifications.

CKD-5D patients with established osteoporosis will be enrolled into one of two treatment arms based on bone turnover status. Each arm will be adaptively randomized by race, age and gender into treatment or control groups. In the low turnover arm, teriparatide combined with cinacalcet will be given, and in the normal or high turnover arm, alendronate will be administered. Bone mineral density will be measured at baseline and after one year of treatment by quantitative computed tomography. Calcifications of the coronaries, aorta and heart valves will also be measured at the same times by multi-detector computed tomography.

If this proof-of-concept study is successful, it will offer a heretofore unavailable treatment for osteoporosis in CKD-5D patients thus changing the prevailing clinical practice paradigm. This will provide immediate benefit to CKD patients by reducing fracture risk, bone pain, and cardiovascular risk, while greatly improving their quality of life. These improvements will also convey major socioeconomic benefits by decreasing the high associated treatment costs. The proposed study is highly relevant to the National Institute of Diabetes and Digestive and Kidney Diseases' mission of disseminating science-based information to improve the health and quality of life for patients with endocrine, metabolic and kidney diseases.


Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: Alendronate Drug: Teriparatide Drug: Cinacalcet Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Osteodystrophy: A Fresh Approach
Study Start Date : July 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control, low turnover
No intervention in low turnover osteoporosis control group.
Experimental: Treatment, low turnover
Low turnover osteoporosis group treated with teriparatide and cinacalcet.
Drug: Teriparatide Drug: Cinacalcet
No Intervention: Control, high turnover
No intervention in high turnover osteoporosis control group.
Experimental: Treatment, high turnover
High turnover osteoporosis group treated with alendronate.
Drug: Alendronate



Primary Outcome Measures :
  1. Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip [ Time Frame: 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 Outcome Measures :
  1. Coronary Artery Calcifications by Multiple Detector Computed Tomography (MDCT) [ Time Frame: One year ]
    At one year the investigators will asses differences between the treatment and control groups in changes in Coronary Artery Calcifications by MDCT.

  2. Serum biochemical bone markers of bone activity [ Time Frame: Six months and One year ]
    Bone markers of bone activity tracked over time for changes.



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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 21 years or older;
  • Chronic maintenance dialysis of at least 3 months' duration;
  • Osteoporotic by DXA of either spine or total hip (Women: post-menopausal or age ≥ 50 with T-score ≤ -2.5; Men: age ≥ 50 with T-score ≤ -2.5; All others, Z-score ≤ -2.5);
  • Mental competence;
  • Willingness to participate in the study;
  • Normal serum calcium.

Exclusion Criteria:

  • Pregnancy or breast feeding;
  • Incarceration;
  • Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 diabetes mellitus);
  • Clinical condition that may limit study participation (e.g., unstable angina, respiratory distress, infections).
  • Chronic alcoholism and/or drug addiction;
  • Known Paget 's disease of bone;
  • Prior external beam or implant radiation therapy involving the skeleton;
  • More than 3 computed tomography (CT) scans in the prior 12 months (to avoid excessive radiation exposure);
  • Participation in a study of an investigational drug during the past 90 days;
  • Planning to move out of the area within 1 year of the study;
  • On active transplant list;
  • BMD t-score of the radius less than -3.5 by DXA (to avoid the known potential negative effects of teriparatide treatment on BMD of the radius);
  • Planned or anticipated oral surgery within the next 12 months;
  • Inability to stand or sit upright for at least 30 minutes;
  • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia;
  • Treatment within last 6 months with drugs that may affect bone metabolism including bisphosphonates and teriparatide (except for treatment with calcitriol, vitamin D analogs and/or calcimimetics);
  • Current treatment with medicines containing digoxin or warfarin;
  • Calcidiol level below the normal range. (The current routine clinical practice in our dialysis clinics is to check calcidiol status twice yearly and supplement with vitamin D according to serum calcidiol levels. It is therefore unlikely that a substantial number of patients will be excluded due to this exclusion criterion.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440581


Contacts
Contact: Hartmut Malluche, MD 859-323-5049 hhmall@uky.edu
Contact: Nedda Hughes, PA 859-218-1509 nkhugh1@uky.edu

Locations
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Nedda Hughes, PA    859-218-1509    nkhugh1@uky.edu   
Contact: Kim McLaughlin, PA    859-323-2672    kim.mclaughlin@uky.edu   
Sponsors and Collaborators
Hartmut Malluche, MD
Wright State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Hartmut Malluche, MD University of Kentucky

Responsible Party: Hartmut Malluche, MD, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT02440581     History of Changes
Other Study ID Numbers: 14-0976-F6A
R01DK080770 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Chronic Kidney Disease-Mineral and Bone Disorder
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperparathyroidism, Secondary
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Alendronate
Teriparatide
Cinacalcet Hydrochloride
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists