Eficácia e segurança do doxercalciferol (1α hidroxivitamina D2) na coluna vertebral e no fémur densidade mineral óssea em mulheres osteopénicas pós-menopáusicas

Resumo original em inglês

O que aconteceu

The use of small doses of vitamin D3 analogs or metabolites is common in the prevention of renal osteodystrophy. Their use in the treatment of osteoporosis has been limited by their potent adverse effects, causing hypercalcemia and hypercalciuria. We evaluated a vitamin D2 analog, i.e., 1α-hydroxyvitamin D2 (doxercalciferol), that has a lower incidence of adverse effects.

In a 1-year pilot randomized double-blind, placebo-controlled study, 55 postmenopausal women (aged 60-71 years) with osteopenia were treated for a year with either doxercalciferol or placebo, and 41 women completed an optional second year. The dose of 1 µg was increased by 1 µg at weekly intervals to a maximum of 5 µg. The daily dose of doxercalciferol averaged 4.1 µg after 12 months and 3.6 µg after 24 months. Bone mineral density (BMD) measurements by dual-energy X-ray absorptiometry (DEXA) of the spine and femoral neck were obtained at 6-month intervals for 24 months. The serum and urine calcium levels were measured frequently for safety.

https://clinicaltrials.gov/, identifier NCT07660536.

O que encontraram

In the primary intention-to-treat (ITT) analysis at 12 months, there was no significant difference between the two groups for femoral neck and spine BMD. At 24 months, there was a significant difference in favor of doxercalciferol for femoral neck BMD, with the treatment/placebo difference being 1.70% (p 10.2 mg/dl), in five patients. The mean 24-h urine calcium increased by 3.75 mmol (150 mg), with 16 episodes of hypercalciuria, 10 mmol (>400 mg), in 12 patients.

Por que isso importa

The results show that doxercalciferol treatment showed no difference from the placebo group on bone loss at 12 months; however, at 24 months, doxercalciferol showed significant prevention of bone loss from the femoral neck and spine.

Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.