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Titolo:
The Danish osteoporosis prevention study (DOPS): project design and inclusion of 2000 normal perimenopausal women
Autore:
Mosekilde, L; Hermann, AP; Beck-Nielsen, H; Charles, P; Nielsen, SP; Sorensen, OH;
Indirizzi:
Aarhus,Univ, Aarhus Kommune Hosp, Dept Endocrinol & Metab, DK-8000 Aarhus C Aarhus Univ Aarhus Denmark C , Dept Endocrinol & Metab, DK-8000 Aarhus C Odense Univ Hosp, Dept Endocrinol, DK-5000 Odense, Denmark Odense Univ Hosp Odense Denmark DK-5000 ocrinol, DK-5000 Odense, Denmark Cent Hosp Hillerod, Dept Clin Physiol & Nucl Med, Hillerod, Denmark Cent Hosp Hillerod Hillerod Denmark ysiol & Nucl Med, Hillerod, Denmark Copenhagen Municipal Hosp, Osteoporosis Res Ctr, Copenhagen, Denmark Copenhagen Municipal Hosp Copenhagen Denmark s Ctr, Copenhagen, Denmark
Titolo Testata:
MATURITAS
fascicolo: 3, volume: 31, anno: 1999,
pagine: 207 - 219
SICI:
0378-5122(19990315)31:3<207:TDOPS(>2.0.ZU;2-V
Fonte:
ISI
Lingua:
ENG
Soggetto:
APPENDICULAR BONE MASS; HIP-FRACTURES; RISK-FACTORS; POSTMENOPAUSAL OSTEOPOROSIS; ALKALINE-PHOSPHATASE; FRAGILITY FRACTURES; REPLACEMENT THERAPY; RISING INCIDENCE; PROXIMAL FEMUR; OLDER WOMEN;
Keywords:
low bone mass; osteoporotic fractures; hormone replacement therapy;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
61
Recensione:
Indirizzi per estratti:
Indirizzo: Mosekilde, L Aarhus Univ, Aarhus Kommune Hosp, Dept Endocrinol & Metab, Tage Hansensgade Aarhus Univ Tage Hansensgade 2 Aarhus Denmark C Hansensgade
Citazione:
L. Mosekilde et al., "The Danish osteoporosis prevention study (DOPS): project design and inclusion of 2000 normal perimenopausal women", MATURITAS, 31(3), 1999, pp. 207-219

Abstract

Objective: In 1990 we initiated a 20 year, partly randomised study (DanishOsteoporosis Prevention Study, DOPS) in order to (a) evaluate clinical, biochemical and osteodensirometric variables as predictors of low bone mass and future osteoporotic fractures, and (b) test the hypothesis, that hormonereplacement therapy (HRT) initiated shortly after menopause reduces the risk of later osteoporotic fractures. This report describes study design and baseline characteristics of the DOPS-cohort. Methods: The study design is pragmatic, attempting to mimic the normal clinical situation. Several HRT alternatives are available according to clinical need. It was considered futile, impractical and unethical to use placebo for 20 years. Instead the study focus on hard endpoints (fractures) confirmed by independent persons (peripheral fractures) or by methods which allow investigator blinding (spinal X-rays). Statistical evaluation will focus on intention to treat analyses evaluating the decision of HRT and it's feasibility. With a compliance of 60% we will have sufficient statistical power (88%) to detect a fracture reduction of 40% in the treatments group. Clinical risk factors, current daily intakes of macronutrients, vitamins and minerals, anthropometric variables,biochemical variables (including bone markers and 25-hydroxyvitamin D), regional bone mineral density (BMD) and total body composition were assessed in all participants at entry and at various follow up intervals. Results: 2016 study participants were recruited by direct mailing to a random sample of 45-58 years old women. In the randomised arm 501 were allocated to HRT and 505 to no treatment. In the non-randomised arm 219 preferred HRT and 791preferred no treatment. Post-randomisation analysis revealed a slight but significant difference in age (50.01 versus 50.44 years) but no difference in menopausal age, prevalence of hysterectomy, educational level, BMI, serum bone alkaline phosphatase, serum osteocalcin, urine hydroxyproline of serum 25-hydroxyvitamin D. In the non-randomised arm women preferring HRT werecloser to menopause, had a higher prevalence of hysterectomy, were better educated, were leaner, and had lower bone turnover than the women, who refused HRT. Conclusion : It is possible to include a sufficient number of perimenopausal women in a randomised 20 year study on the antifracture effect of HRT. (C) 1999 Elsevier Science Ireland Ltd. All rights reserved.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 27/11/20 alle ore 06:29:43