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Theophylline as a Treatment for Children With Pseudohypoparathyroidism Type 1a (Albright Hereditary Osteodystrophy)

Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pseudohypoparathyroidism Type 1a; Albright Hereditary Osteodystrophy

Intervention: Theophylline (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
Ashley H Shoemaker, MD, MSCI, Principal Investigator, Affiliation: Vanderbilt University

Overall contact:
Ashley H Shoemaker, MD, MSCI, Phone: 615-343-8116, Email: Ashley.H.Shoemaker@Vanderbilt.edu


This study will test an investigational drug, theophylline, in children with pseudohypoparathyroidism type 1a (PHP1a). This study involves a 3 day visit to the Vanderbilt Clinical Research Center.

Clinical Details

Official title: Effects of Theophylline on cAMP Signaling in Children With Pseudohypoparathyroidism Type 1a

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Urine cAMP

Secondary outcome:

Resting Energy Expenditure (REE)

Apnea Hypopnea Index (AHI)


Minimum age: 10 Years. Maximum age: 21 Years. Gender(s): Both.


Inclusion Criteria: 1. Age 10 to 21 years old 2. English proficiency 3. Clinical and genetic diagnosis of PHP1a Exclusion Criteria: 1. Use of a PDE inhibitor in the past 30 days 2. History of a seizure disorder unrelated to hypocalcemia 3. History of a cardiac arrhythmia (not including bradycardia) 4. History of hepatic insufficiency 5. AST or ALT >2x upper limit of normal 6. Total bilirubin >1. 5 x upper limit of normal (unless patient has a diagnosis of Gilbert's syndrome and no other causes leading to hyperbilirubinemia are identified) 7. Congestive heart failure 8. Cigarette use in the past 30 days 9. Alcohol use within the past 24 hours 10. Current pregnancy 11. Untreated hypothyroidism (defined as free T4 level < 0. 6 ng/dL or TSH >10 mcU/mL) 12. Active peptic ulcer disease 13. Fever >101 degrees in the past 24 hours 14. Current use of medications known to effect theophylline levels (listed below) 15. Severe sleep apnea requiring BiPAP Drugs with clinically significant drug interactions with theophylline:

- Allopurinol

- Cimetidine

- Ciprofloxacin

- Clarithromycin

- Enoxacin

- Ephedrine

- Erythromycin

- Estrogen

- Flurazepam

- Fluvoxamine

- Lithium

- Lorazepam

- Methotrexate

- Midazolam

- Pentoxifylline

- Propranolol

- Rifampin

- Sulfinpyrazone

- Tacrine

- Thiabendazole

- Ticlopidine

- Troleandomycin

- Verapamil

Locations and Contacts

Ashley H Shoemaker, MD, MSCI, Phone: 615-343-8116, Email: Ashley.H.Shoemaker@Vanderbilt.edu

Vanderbilt Unversity, Nashville, Tennessee 37232, United States; Recruiting
Ashley Shoemaker, MD, Phone: 615-343-8116, Email: Ashley.H.Shoemaker@vanderbilt.edu
Margo Black, MSN, Phone: 615-343-5846, Email: margo.black@vanderbilt.edu
Ashley Shoemaker, MD, Principal Investigator
Additional Information

Vanderbilt PHP Research Page

Related publications:

Landreth H, Malow BA, Shoemaker AH. Increased Prevalence of Sleep Apnea in Children with Pseudohypoparathyroidism Type 1a. Horm Res Paediatr. 2015;84(1):1-5. doi: 10.1159/000381452. Epub 2015 Apr 23.

Shoemaker AH, Lomenick JP, Saville BR, Wang W, Buchowski MS, Cone RD. Energy expenditure in obese children with pseudohypoparathyroidism type 1a. Int J Obes (Lond). 2013 Aug;37(8):1147-53. doi: 10.1038/ijo.2012.200. Epub 2012 Dec 11.

Starting date: June 2015
Last updated: June 2, 2015

Page last updated: August 23, 2015

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