We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Cinacalcet on Parathyroid Hormone Secretion in Children and Adolescents With Hypophosphatemic Rickets

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2005 by Children's Mercy Hospital Kansas City.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00195936
First Posted: September 20, 2005
Last Update Posted: October 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Children's Mercy Hospital Kansas City
  Purpose
This study will measure the effect of cinacalcet (Sensipar) on parathyroid hormone (PTH) secretion in children and adolescents with hypophosphatemic rickets (XLH). The investigators are seeking evidence that patients with XLH may benefit from treatment with cinacalcet by achieving better control of PTH secretion.

Condition Intervention Phase
Hypophosphatemic Rickets, X-Linked Dominant Drug: Cinacalcet Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Calcimimetic (Cinacalcet) on Phosphate-Induced Hyperparathyroidism in Children With Hypophosphatemic Rickets

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • The primary outcome will be the effect of cinacalcet on serum PTH. [ Time Frame: PTH will be measured at time 0 and then every 30 minutes for 4 hours after receiving the medications ]

Secondary Outcome Measures:
  • Secondary outcome will be the effect of the calcimimetic on mineral homeostasis; ionized calcium, total calcium, and phosphate will be measured. [ Time Frame: At time 0 and then every 30 minutes for 4 hours after receiving the medications ]

Study Start Date: June 2005
Detailed Description:

X-linked hypophosphatemic rickets (XLH) is an X-linked dominant genetic disorder. Common findings are low serum phosphate and inadequate 1,25(OH)2 vitamin D production. It is generally believed that the primary defect in XLH is impaired renal tubular transport of phosphate coupled with abnormal regulation of the enzyme responsible for the 1-alfa hydroxylation of 25(OH) vitamin D. The current treatment of children with XLH is large oral doses of phosphate and 1,25-dihydroxyvitamin D. There are two common side effects to this treatment; nephrocalcinosis and secondary hyperparathyroidism (HPT). The latter at times may cause hypertension, hypercalcemia, and permanent renal damage. The complication of secondary hyperparathyroidism is seen in 20% of the patients. The release of PTH from the glands into the circulation is tightly regulated by serum calcium concentration. The glands "read" serum calcium concentration via Ca sensing receptors (CaR) which are located at the surface of the glands. Calcimimetics are compounds that allosterically modulate the CaR, thereby enhancing its sensitivity to circulating serum calcium concentrations and consequently decreasing PTH secretion. When used in primary HPT, they rapidly reduce PTH level and normalize serum calcium concentration.

Cinacalcet is a calcimimetic agent recently approved by the FDA for treating hypercalcemia in patients with parathyroid carcinoma and secondary HPT in patients with chronic renal disease. Cinacalcet was found to be effective in decreasing both PTH level and the calcium X phosphorous ion product in dialysis patients.

The goal of our proposed acute study is to see whether concomitant administration of Cinacalcet and phosphate, to patients with XLH, will block completely or partially secretion of PTH (day 2), expected to be seen following administration of phosphate alone (day 1). We will also monitor serum phosphate, total calcium, and ionized calcium concentration to learn to what extent, if any, blockage of PTH secretion affects mineral homeostasis under this condition.

If found to be effective in blocking PTH secretion, Cinacalcet will become a candidate for a long-term study in children with XLH to protect them from developing secondary hyperparathyroidism.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Established patients with XLH
  • Age 5 years old and above
  • Normal serum calcium and creatinine concentrations

Exclusion Criteria:

  • Patients with hypersensitivity to any component(s) of cinacalcet
  • Hypocalcaemia
  • Elevated serum creatinine
  Contacts and Locations
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): NCT00195936


Contacts
Contact: Rachel Levy-Olomucki, MD 816-234-3010 rlevy@cmh.edu

Locations
United States, Missouri
Section of Pediatric Nephrology, Children's Mercy Hospitals and Clinics Recruiting
Kansas City, Missouri, United States, 64108
Principal Investigator: Rachel Levy-Olomucki, MD         
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Rachel Levy-Olomucki, MD Section of Pediatric Nephrology, Children's Mercy Hospitals and Clinics
  More Information

ClinicalTrials.gov Identifier: NCT00195936     History of Changes
Other Study ID Numbers: 05 02-027
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: October 23, 2007
Last Verified: August 2005

Keywords provided by Children's Mercy Hospital Kansas City:
Cinacalcet
PTH
XLH
children and adolescents with hypophosphatemic rickets (XLH)

Additional relevant MeSH terms:
Rickets
Rickets, Hypophosphatemic
Familial Hypophosphatemic Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hypophosphatemia
Phosphorus Metabolism Disorders
Hypophosphatemia, Familial
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs


To Top