Skeletal Effects of Levothyroxine for Subclinical Hypothyroidism in Older Adults: A TRUST Randomized Trial Nested Study
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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.
In: The Journal of clinical endocrinology and metabolism, Vol. 105, No. 1, 2020, p. 336–343.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Skeletal Effects of Levothyroxine for Subclinical Hypothyroidism in Older Adults
T2 - A TRUST Randomized Trial Nested Study
AU - Gonzalez Rodriguez, Elena
AU - Stuber, Mirah
AU - Del Giovane, Cinzia
AU - Feller, Martin
AU - Collet, Tinh Hai
AU - Löwe, Axel L.
AU - Blum, Manuel R.
AU - van Vliet, Nicolien A.
AU - van Heemst, Diana
AU - Kearney, Patricia M.
AU - Gussekloo, Jacobijn
AU - Mooijaart, Simon
AU - Westendorp, Rudi G.J.
AU - Stott, David J.
AU - Aeberli, Daniel
AU - Bauer, Douglas C.
AU - Hans, Didier
AU - Rodondi, Nicolas
PY - 2020
Y1 - 2020
N2 - CONTEXT: Both thyroid dysfunction and levothyroxine (LT4) therapy 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 versus 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 percentage changes of BMD, TBS, and 2 serum BTMs (serum CTX-1 [sCTX] and procollagen type 1 N-terminal polypeptide [P1NP]). Student's t-test for unadjusted analyses and linear regression adjusted for clinical center and sex were performed. RESULTS: Mean age was 74.3 years ± 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% confidence interval [CI] -0.1 to 2.9, P = .059). Likewise, there were no between-group differences in 1-year change in TBS (-1.3%: 95% CI -3.1 to 0.6, P = .19), total hip BMD (-0.2%: 95% CI -1.1 to 0.1, P = .61), or BTMs levels (sCTX +24.1%: 95% CI -7.9 to 56.2, P = .14), or after adjustment for clinical centers and sex. CONCLUSIONS: Over 1-year levothyroxine had no effect on bone health in older adults with SHypo. REGISTRATION: ClinicalTrial.gov NCT01660126 and NCT02491008.
AB - CONTEXT: Both thyroid dysfunction and levothyroxine (LT4) therapy 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 versus 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 percentage changes of BMD, TBS, and 2 serum BTMs (serum CTX-1 [sCTX] and procollagen type 1 N-terminal polypeptide [P1NP]). Student's t-test for unadjusted analyses and linear regression adjusted for clinical center and sex were performed. RESULTS: Mean age was 74.3 years ± 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% confidence interval [CI] -0.1 to 2.9, P = .059). Likewise, there were no between-group differences in 1-year change in TBS (-1.3%: 95% CI -3.1 to 0.6, P = .19), total hip BMD (-0.2%: 95% CI -1.1 to 0.1, P = .61), or BTMs levels (sCTX +24.1%: 95% CI -7.9 to 56.2, P = .14), or after adjustment for clinical centers and sex. CONCLUSIONS: Over 1-year levothyroxine had no effect on bone health in older adults with SHypo. REGISTRATION: ClinicalTrial.gov NCT01660126 and NCT02491008.
U2 - 10.1210/clinem/dgz058
DO - 10.1210/clinem/dgz058
M3 - Journal article
C2 - 31702015
VL - 105
SP - 336
EP - 343
JO - Journal of Clinical Endocrinology and Metabolism
JF - Journal of Clinical Endocrinology and Metabolism
SN - 0021-972X
IS - 1
ER -
ID: 235592800