A. Dorst

Avoidance of Vertebral Fractures in Men with Idiopathic Osteoporosis by a Three Year Therapy with Calcium and Low-Dose Intermittent Monofluorophosphate

Abstract. There are currently no trial-based recommendations for the treatment of idiopathic osteoporosis in man. A prospective, controlled, randomized 3-year study was conducted to evaluate the effects of intermittent, low-dose fluoride combined with continuous calcium supplementation on bone mass and future fracture events in men with this disease. Sixty-four men with idiopathic osteoporosis (mean age 53 years; mean T-score at L2–4, −2.75) and no previous vertebral fractures were randomly assigned to two treatment groups. Group A received intermittent (3 months on, 1 month off) treatment with monofluorophosphate 114 mg/day (i.e. 15 mg fluoride ions) plus continuous calcium supplementation (950–1000 mg/day). Group B received continuous calcium (1000 mg/day) alone. Bone mineral density was measured at the lumbar spine, hip and radius at 6-months intervals, thoracic and lumbar spine radiographs were obtained every 12 months. In group A bone density increased at all sites (by between +1.2% and +8.8%), while group B showed moderate decreases (by between -1.4% and -5.2%). After 36 months, bone densities at all sites in group A were significantly hither than those of group B. Three patients (10%) in group A suffered a total of 4 vertebral fractures versus 12 patients (40%) with 17 fractures in group B (p = 0.008). Non-vertebral fractures occurred in 3 patients in group A versus 11 in group B, though this difference was not significant. Back pain was significantly reduced in group A and unchanged in group B (after 3 years p = 0.0003). All side-effects were mild and transient. Early treatment of idiopathic osteoporosis in the male using the fluoride-calcium regimen we tested can improve cancellous and cortical bone density, reduce the incidence of vertebral fractures and attenuate back pain.

Efficacy of etidronate and sequential monofluorophosphate in severe postmenopausal osteoporosis: a pilot study

In a three-year pilot study on 52 women with severe postmenopausal osteoporosis, treatment with etidronate followed by calcium and vitamin D (ECaD) was compared to etidronate followed by monofluorophosphate, calcium and vitamin D (EFCaD). BMD in lumbar spine, total hip and femoral neck increased significantly more with EFCaD than with ECaD. Pain-mobility score decreased significantly more with EFCaD than with ECaD (p=0.006). New vertebral fractures occurred in three patients under EFCaD (12%) and in nine under ECaD (35%), (p=0.048). Three patients under EFCaD (12%) and 15 under ECaD (58%) did not respond to therapy (p of difference=0.001). Mild or moderate adverse reactions were reported by 25 patients, with no significant difference between the two groups. The pilot study suggests that etidronate, sequentially followed by monofluorophosphate, could be a safe, effective and relatively inexpensive therapy in severe postmenopausal osteoporosis.

Erfahrungen mit Raloxifen in der osteologischen Spezialambulanz - Eine monozentrische Anwendungsbeobachtung

86 wegen Osteoporose oder Osteopenie mit Raloxifen 60 mg behandelte postmenopausale Frauen wurden in einer osteologischen Spezialambulanz uber zwei Jahre beobachtet. Insgesamt stieg die Knochenmineraldichte im Mittel um 2,5% in der LWS und um 2,7% in der Hufte. Drei neue Wirbelkorperfrakturen traten im ersten Jahr auf, im zweiten keine. 7 Patientinnen erlitten je eine extravertebrale Fraktur. Der Anteil von Patientinnen mit Ruckenschmerzen ging von 84,9% auf 29,1% zuruck. Die mittlere Gesamcholesterinkonzentration im Serum sank um 5,0%, LDL-C um 8,5%. Es traten 23 unerwunschte Ereignisse auf, die – von einigen der Frakturen abgesehen – in keinem Falle schwerwiegend waren. 79 der 86 Frauen nahmen zu Beobachtungsende die Medikation noch immer regelmasig ein. Die Ergebnisse bestatigen, dass die Resultate vorausgegangener kontrollierter klinischer Studien zu Wirksamkeit und Vertraglichkeit von Raloxifen auch unter naturalistischen Praxisbedingungen reproduzierbar sind. Der eindrucksvolle Ruckgang der Ruckenschmerzen ist hingegen ein neuer Befund, der zwar in einer vorausgehenden Anwendungsbeobachtung schon einmal beschrieben, in kontrollierten Studien aber bisher nicht untersucht wurde.