The effect of low-dose continuous estrogen and progesterone therapy with calcium and vitamin D on bone in elderly women. A randomized, controlled trial
Recker RR, Davies KM, Dowd RM, Heaney RP
Annals of internal medicine · 127 citas
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 independiente
- Gobierno
- National Institute of Arthritis and Musculoskeletal and Skin Diseases
- Gobierno
- NIAMS NIH HHS
- Subvenciones
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (AR 39221)
Según 2 financiadores declarados.
Publicación
- Publicado
- 1999-06-01 · Ann Intern Med · vol. 130 · número 11 · págs. 897–904
- Editorial
- American College of Physicians
- Citado
- 243 citas · más que el 100% de estudios similares · 21.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 53 trabajos
- Acceso
- De pago
- Áreas de investigación
- Menopause: Health Impacts and Treatments · Bone health and osteoporosis research · Estrogen and related hormone effects
- Palabras clave
- hormone replacement therapy, low-dose estrogen, conjugated equine estrogens, medroxyprogesterone, osteoporosis prevention, bone mineral density, older women, calcium supplementation, vitamin D supplementation, 25-hydroxyvitamin D, bone turnover markers, osteocalcin, alkaline phosphatase, urinary hydroxyproline, treatment tolerability
- MeSH
- humans, osteoporosis, postmenopausal, calcium, creatinine, medroxyprogesterone, estrogens, conjugated (usp), alkaline phosphatase, vitamin d, hydroxyproline, osteocalcin, estrogen replacement therapy, analysis of variance, bone density, dietary supplements, aged, female, biomarkers
4 autores
- Robert R. Recker🇺🇸 · autor de correspondenciaCreighton University
- K. Michael Davies🇺🇸Creighton University
- Rachel M. Dowd🇺🇸Creighton University
- Robert P. Heaney🇺🇸Creighton University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Hormone replacement therapy (HRT), the mainstay of osteoporosis prevention, is limited because of dose-related risks, side effects, and patient acceptance. The bone-sparing efficacy and tolerability of the lowest available doses of HRT have not been adequately studied in elderly women.
Objective
To determine the bone-sparing effect of continuous low-dose HRT in elderly women.
Design
Randomized, double-blind, placebo-controlled trial.
Setting
University osteoporosis research and clinical center.
Patients
128 healthy white women (age > 65 years) with low bone mass recruited by word of mouth and by local advertisement. The principal eligibility criterion was spinal bone mineral density of 0.90 g/cm2 or less.
Intervention
Continuous therapy with conjugated equine estrogen, 0.3 mg/d, and medroxyprogesterone, 2.5 mg/d, or matching placebo. Sufficient calcium supplementation was given to bring all calcium intakes above 1000 mg/d in both groups; supplemental oral 25-hydroxyvitamin D was given to maintain serum 25-hydroxyvitamin D levels of at least 75 nmol/L in both groups.
Measurements
Bone mineral density of the spine, hip, total body, and forearm; serum total alkaline phosphatase and serum osteocalcin levels at 6-month intervals; and 24-hour urine creatinine and hydroxyproline excretion at baseline, 12 months, and 42 months.
Results
During 3.5 years of observation, spinal bone mineral density increased by 3.5% (P < 0.001) in an intention-to-treat analysis and by 5.2% among patients with greater than 90% adherence to therapy. Significant increases were seen in total-body and forearm bone density (P < 0.01). Symptoms related to HRT (breast tenderness, spotting, pelvic discomfort, and mood changes) were mild and short-lived.
Conclusions
Continuous low-dose HRT with conjugated equine estrogen and oral medroxyprogesterone combined with adequate calcium and vitamin D provides a bone-sparing effect that is similar or superior to that provided by other, higher-dose HRT regimens in elderly women. This combination is well tolerated by most patients.
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