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ID
Source
Brief title
Health condition
Hypothyrodism
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the proportion of participants that withdraw their thyroid medication successfully, defined as normal fT4 levels and TSH levels <10 mU/L, at 52 weeks after start of the discontinuation of levothyroxine.
Secondary outcome
Effects of discontinuing levothyroxine on thyroid-related quality of life including somatic, psychological and social domains; general health; treatment satisfaction for medication; daily functioning.
The proportion of levothyroxine users who can achieve a substantial dose lowering of their levothyroxine dose after one year.
Demographic, clincal characteristics and attitudes towards discontinuation of those levothyroxine users aged 60 years and older willing to discontinue levothyroxine treatment and those successfully reducing their dosage.
Characteristics of persons aged 60 years and older that physicians consider safe to withdraw thyroid medication from, and medical reasons not to discontinue treatment. Frequency of discontinuation (or stepping-down) levothyroxine treatment by general practitioners in usual care .
Physicians’ experience on the recruitment of patients and the consultations.
Study participants’ experience of discontinuation of medication.
Background summary
Many older persons in the Netherlands use levothyroxine (2015: >215.000 aged 65+), and often have been using levothyroxine for a very long time. Initial indications for treatment are often not well registered, inaccurate or even inappropriate due to changing guidelines. Currently, levothyroxine treatment is indicated for patients with overt hypothyroidism (high Thyroid Stimulating Hormone [TSH], low free Thyroxin [fT4]). For subclinical hypothyroidism (high TSH, normal fT4), the most common thyroid disorder in older people (3-18% aged 65+), guidelines vary. Recently, in the TRUST trial, it was shown that levothyroxine treatment was not clinically beneficial in people aged 65 years and older with subclinical hypothyroidism. Given the high prevalence of levothyroxine use, the ambiguous treatment indications, the lack of evidence for beneficial effects of treatment and the health risks associated with (over)treatment, we hypothesize that discontinuation of levothyroxine is feasible in many older persons without negative consequences.
An self-controlled observational study will be performed investigating the stepwise reduction of levothyroxine treatment in persons aged 60 years and older. The primary aim is to study what proportion of participants that withdraw their levothyroxine successfully, defined as having normal fT4 levels and TSH levels <10 mU/L at 52 weeks after start of the discontinuation.
Study objective
At least 50% of older patients using levothyroxine treatment can be withdrawn successfully and safely.
Study design
Run-in period (from t = -12 weeks): baseline measurement of thyroid function (TSH and fT4), questionnaires, continuation of levothyroxine treatment.
Discontinuation phase (from t = 0 weeks): stepwise reduction of levothyroxine based on measurements of TSH and fT4; questionnaires.
Follow-up phase: measurement of thyroid function and questionnaires.
Intervention
Stepwise reduction of levothyroxine treatment.
Rosalinde Poortvliet
0715268444
r.k.e.poortvliet@lumc.nl
Rosalinde Poortvliet
0715268444
r.k.e.poortvliet@lumc.nl
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1) Aged 60 years or over (≥ 60 years)
2) Using any levothyroxine mono-therapy medicament (ATC: H03AA01) continuously for a minimum of 1 year with stable dose of levothyroxine.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1) Last measurement of TSH ≥10 mU/L during levothyroxine treatment
2) Current reason for levothyroxine treatment: patients with history of thyroidectomy; radioactive iodine treatment or neck irradiation; congenital hypothyroidism; secondary hypothyroidism, or concurrent amiodarone or lithium use
3) Dose of treatment; for safety issues, patients using > 150 mcg levothyroxine per day (0.48%) will not be eligible
4) Diagnosis of heart failure NYHA grade IV
5) Participation in ongoing trials of therapeutic interventions
6) Life-expectancy of less than 6 months
7) Diagnosis of dementia
8) Incapacitated adults
9) Persons that plan to move out of the region in which the study is being conducted in the next months.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7978 |
| CCMO | NL69753.058.19 |
| OMON | NL-OMON52395 |