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

NCT00195936 | Completed Phase 1

• 1 other identifier: 05 02-027
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypophosphatemic Rickets, X-Linked Dominant

Keywords

Cinacalcet; PTH; XLH; children and adolescents with hypophosphatemic rickets (XLH)

Outcome Measures

Primary Outcomes (1)

• Change of serum Parathyroid Hormone (PTH) with use of cinacalcet

  Baseline, 30 minutes, and 4 hours post dose

Secondary Outcomes (1)

• Change of mineral homeostasis; ionized calcium, total calcium, and phosphate with use of calcimimetic

  Baseline, 30 minutes, and 4 hours post dose

Study Arms (1)

Overall Study

EXPERIMENTAL

Calcimimetics as an Adjuvant Treatment for Familial Hypophosphatemic Rickets

Drug: Cinacalcet

Interventions

Cinacalcet DRUG

Single oral dose of Cinacalcet for children with Hypophosphatemic Rickets

Overall Study

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with hypersensitivity to any component(s) of cinacalcet
• Hypocalcaemia
• Elevated serum creatinine

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Section of Pediatric Nephrology, Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Familial Hypophosphatemic Rickets

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Rickets, Hypophosphatemic; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Hypophosphatemia, Familial; Renal Tubular Transport, Inborn Errors; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metal Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Hypophosphatemia; Phosphorus Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Rachel Levy-Olomucki, MD

  Section of Pediatric Nephrology, Children's Mercy Hospitals and Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

US (1)