A new active vitamin D, ED-71, increases bone mass in osteoporotic patients under vitamin D supplementation: a randomized, double-blind, placebo-controlled clinical trial
Matsumoto T, Miki T, Hagino H, Sugimoto T, Okamoto S, Hirota T, Tanigawara Y, Hayashi Y, Fukunaga M, Shiraki M, Nakamura T
The Journal of clinical endocrinology and metabolism · 103 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2005-09-01 · J Clin Endocrinol Metab · vol. 90 · número 9 · págs. 5031–5036
- Editorial
- Oxford University Press
- Citado
- 140 citas · más que el 95% de estudios similares · 5.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 13 trabajos
- Acceso
- De pago
- Áreas de investigación
- Bone health and osteoporosis research · Vitamin D Research Studies · Bone Metabolism and Diseases
- Palabras clave
- ED-71, active vitamin D, osteoporosis, bone mineral density, vitamin D supplementation, lumbar spine, hip bone density, bone turnover markers, hypercalcemia, bone formation and resorption
- MeSH
- lumbar vertebrae, hip joint, humans, osteoporosis, hypercalcemia, calcium, calcitriol, hormones, vitamin d, absorptiometry, photon, double-blind method, patient compliance, bone remodeling, bone density, dose-response relationship, drug, aged, aged, 80 and over, middle aged, female, male, biomarkers
11 autores
- Toshio Matsumoto🇯🇵 · autor de correspondenciaTokushima University
- Takami Miki🇯🇵Osaka City University
- Hiroshi Hagino🇯🇵Tottori University
- Toshitsugu Sugimoto🇯🇵Kobe University
- Sumiaki Okamoto
- Takako Hirota
- Yusuke Tanigawara🇯🇵Keio University Hospital
- Yasufumi Hayashi🇯🇵Tokyo Metropolitan Institute of Gerontology; Tokyo Metropolitan Geriatric Hospital
- Masao Fukunaga🇯🇵Kawasaki Medical School
- Masataka Shiraki🇯🇵Research Institute and Practice for Involutional Diseases
- Toshitaka Nakamura🇯🇵University of Occupational and Environmental Health Japan
Resumen
El texto original del estudio, en el idioma en que se publicó.
Context
ED-71 has been shown to increase lumbar bone mineral density (BMD) in osteoporotic subjects. However, vitamin D insufficiency might have influenced the effect of ED-71 on BMD.
Objective
Our objective was to examine whether ED-71 can increase BMD in osteoporotic patients under vitamin D supplementation.
Design, setting, and patients
We conducted a randomized, double-blind, placebo-controlled clinical trial of 219 osteoporotic patients (49-87 yr of age).
Interventions
Subjects were randomly assigned to receive placebo or 0.5, 0.75, or 1.0 microg/d ED-71 for 12 months. All the subjects received 200 or 400 IU/d vitamin D(3).
Main outcome measures
We assessed changes in lumbar and hip BMD and bone turnover markers from baseline.
Results
Lumbar BMD increased with ED-71 treatment for 12 months (2.2, 2.6, and 3.1% from baseline and 2.9, 3.4, and 3.8% vs. placebo group in subjects receiving 0.5, 0.75, and 1.0 microg ED-71, respectively). Total hip BMD also increased with 0.75 and 1.0 microg ED-71 (-0.8, 0.6, and 0.9% from baseline and 0.1, 1.5, and 1.8% vs. placebo group in the 0.5, 0.75, and 1.0 microg ED-71 groups, respectively). Bone formation and resorption markers were suppressed by approximately 20% after 12 months of 0.75 and 1.0 microg ED-71 treatment. Transient hypercalcemia over 2.6 mmol/liter occurred in 7, 5, and 23% of subjects in the 0.5, 0.75, and 1.0 microg ED-71 groups, respectively, but none of them developed sustained hypercalcemia.
Conclusions
These results demonstrate that ED-71 treatment at around 0.75 microg/d can effectively and safely increase lumbar and hip BMD in osteoporotic patients with vitamin D supplementation.
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