Skeletal Effects of Levothyroxine for Subclinical Hypothyroidism in Older Adults: A TRUST Randomized Trial Nested Study.

Gonzalez Rodriguez, Elena; Stuber, Mirah; Del Giovane, Cinzia; Feller, Martin; Collet, Tinh-Hai; Löwe, Axel L; Blum, Manuel R; van Vliet, Nicolien A; van Heemst, Diana; Kearney, Patricia M; Gussekloo, Jacobijn; Mooijaart, Simon; Westendorp, Rudi G J; Stott, David J; Aeberli, Daniel; Bauer, Douglas C; Hans, Didier; Rodondi, Nicolas (2020). Skeletal Effects of Levothyroxine for Subclinical Hypothyroidism in Older Adults: A TRUST Randomized Trial Nested Study. Journal of clinical endocrinology and metabolism, 105(1) Endocrine Society 10.1210/clinem/dgz058

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CONTEXT Both thyroid dysfunction and levothyroxine therapy (LT4) have been associated with bone loss, but studies on the effect of LT4 for subclinical hypothyroidism (SHypo) on bone yielded conflicting results. OBJECTIVE To assess the effect of LT4 treatment on bone mineral density (BMD), Trabecular Bone Score (TBS), and bone turnover markers (BTMs) in older adults with SHypo. DESIGN AND INTERVENTION Planned nested substudy of the double-blind placebo-controlled TRUST trial. Participants with SHypo were randomized to LT4 with dose titration vs. placebo with computerized mock titration. SETTING AND PARTICIPANTS 196 community-dwelling adults over 65 years enrolled at the Swiss TRUST sites had baseline and 1-year follow-up bone examinations; 4 participants withdrew due to adverse events not related to treatment. MAIN OUTCOME MEASURES One-year percent changes of BMD, TBS, and two serum BTMs (sCTX and P1NP). Student's t-test for unadjusted analyses, and linear regression adjusted for clinical center and sex, were performed. RESULTS Mean age was 74.3y ± 5.7, 45.4% were women, and 19.6% were osteoporotic. The unadjusted 1-year change in lumbar spine BMD was similar between LT4 (+0.8%) and placebo-treated groups (-0.6%; between-groups difference +1.4%: 95%CI -0.1 to 2.9, p=0.059). Likewise, there were no between-group differences in 1-year change in TBS (-1.3%: 95%CI -3.1 to 0.6, p=0.19), total hip BMD (-0.2%: 95%CI -1.1 to 0.1, p=0.61), or BTMs levels (sCTX +24.1%: 95%CI -7.9 to 56.2, p=0.14), or after adjustment for clinical centers and sex. CONCLUSIONS Over one-year levothyroxine had no effect on bone health in older adults with SHypo. REGISTRATION ClinicalTrial.gov NCT01660126 and NCT02491008.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Dermatology, Urology, Rheumatology, Nephrology, Osteoporosis (DURN) > Clinic of Rheumatology, Clinical Immunology and Allergology
04 Faculty of Medicine > Medical Education > Institute of General Practice and Primary Care (BIHAM)
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine > Centre of Competence for General Internal Medicine

UniBE Contributor:

Stuber, Mirah Julia; Del Giovane, Cinzia; Feller, Martin; Löwe, Axel Lennart; Blum, Manuel Raphael; Aeberli, Daniel and Rodondi, Nicolas

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

0021-972X

Publisher:

Endocrine Society

Funders:

[4] Swiss National Science Foundation

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

14 Nov 2019 15:19

Last Modified:

03 Jan 2020 01:32

Publisher DOI:

10.1210/clinem/dgz058

PubMed ID:

31702015

Additional Information:

Didier Hans and Nicolas Rodondi contributed equally to this work.

Uncontrolled Keywords:

Bone markers Bone mineral density Levothyroxine Subclinical hypothyroidism Trabecular Bone Score

BORIS DOI:

10.7892/boris.134897

URI:

https://boris.unibe.ch/id/eprint/134897

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