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NCT Number: NCT03718403

Effect of Theophylline in Pseudohypoparathyroidism

The study evaluates the effect of theophylline in 100 subjects with Pseudohypoparathyroidism.

Recruiting

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Key information

Conditions

PHP Ia Bone Diseases Bone Diseases, Metabolic Calcium Metabolism Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases PHP IB Php1C Pseudohypoparathyroidism Pseudohypoparathyroidism Type 1C

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Amita Sharma

CONTACT

[email protected]

617-726-2908

About this study

It is an open label intervention study for the off-label use of theophylline in psuedohypoparathyroidism (PHP).Theophylline is a is non-specific phosphodiesterase inhibitor which increases the levels of secondary messenger,cAMP. PHP patients have end organ resistance to hormones involving cAMP signaling. Thus, theophylline has a potential to abrogate hormone resistance. Also, it may have a role in bone maturation, neurocognition and metabolism.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with known diagnosis of PHP1A and PHP1B
  • Age >5 years

Exclusion criteria

  • • Significant kidney disease, i.e. any CKD stage
  • Hypercalciuria
  • Kidney stones
  • Severe Heart disease
  • Uncontrolled seizure disorder
  • Peptic ulcer
  • Liver dysfunction
  • Bleeding disorder
  • Allergy to theophylline preparation
  • Muscle disorder
  • Infection
  • Any neurologic disease
  • Chronic drugs interacting with theophylline

Treatment and study plan

Theophylline

Drug

Theophylline will be given to maintain a peak level between 10-15 mcg/mL

Primary outcomes

  1. Effect of Theophylline on Bone Age in PHP

    Time frame: 52 weeks

    Change in Bone age ( in years and months) before and after theophylline administration for 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

AMITA SHARMA, MD

CONTACT

[email protected]

6177262908

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2030
Study completion
2032
First posted
Oct 24, 2018
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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