The Effect of Sodium Monofluorophosphate Plus Calcium on Vertebral Fracture Rate in Postmenopausal Women with Moderate Osteoporosis. A Randomized, Controlled Trial

in Annals of Internal Medicine (1998), 129(1), 1-8

BACKGROUND: Fluoride is effective in increasing trabecular bone mineral density (BMD) in the spine, but its efficacy in reducing vertebral fracture rates and its effect on BMD at cortical sites are ... [more ▼]

BACKGROUND: Fluoride is effective in increasing trabecular bone mineral density (BMD) in the spine, but its efficacy in reducing vertebral fracture rates and its effect on BMD at cortical sites are controversial. OBJECTIVE: To study the effect of low-dose fluoride (sodium monofluorophosphate [MFP]) plus a calcium supplement over 4 years on vertebral fractures and BMD at the lumbar spine and total hip in postmenopausal women with moderately low BMD of the spine. DESIGN: Randomized, double-blind, controlled clinical trial. SETTING: Outpatient clinic for osteoporosis at a university medical center. PATIENTS: 200 postmenopausal women with osteoporosis (according to the World Health Organization definition) and a T-score less than -2.5 for BMD of the spine. INTERVENTION: Women were randomly assigned (100 patients per group) to continuous daily treatment for 4 years with 1) oral MFP (20 mg of equivalent fluoride) plus 1000 mg of calcium (as calcium carbonate) or 2) calcium only. MEASUREMENTS: Lateral spine radiographs were taken at enrollment and at each year of follow-up for detection of new vertebral fractures (defined as a reduction > or =20% and > or =4 mm from baseline in any of the heights of a vertebral body). Nonvertebral fractures were also recorded. All analyses were done with the intention-to-treat approach. RESULTS: Radiologic follow-up was possible for 164 of 200 patients (82%). The rate of new vertebral fractures during the 4 years of the study was lower in the MFP-plus-calcium group (2 of 84 patients; 2.4% [95% CI, 0.3% to 8.3%]) than in the calcium-only group (8 of 80 patients; 10% [CI, 4.4% to 18.8%]). The difference between the groups was 7.6 percentage points (CI, 0.3 to 15 percentage points) (P = 0.05). A moderate but progressive increase in BMD of the spine (10.0% +/- 1.5% at 4 years) was found for MFP plus calcium compared with calcium only (P < 0.001), whereas the more modest increase in BMD of the total hip seen with MFP plus calcium (1.8% +/- 0.6%) did not differ from the increase seen with calcium only. CONCLUSIONS: Low-dose fluoride (20 mg/d) given continuously with calcium for prolonged periods can decrease vertebral fracture rates compared with calcium alone in patients with mild to moderate osteoporosis. [less ▲]

Reproducibility and diagnostic sensitivity of ultrasonometry of the phalanges to assess osteoporosis.

in International Journal of Gynecology & Obstetrics (1998), 63(1), 21-8

OBJECTIVE: The present study was designed to assess the reproducibility and the diagnostic sensitivity of the amplitude-dependent speed of sound (SoS) at the distal metaphysis of the proximal phalanges ... [more ▼]

OBJECTIVE: The present study was designed to assess the reproducibility and the diagnostic sensitivity of the amplitude-dependent speed of sound (SoS) at the distal metaphysis of the proximal phalanges. METHOD: Fourteen presumably healthy volunteers were repeatedly measured every 6 weeks for approximately 6 months in order to assess the reproducibility of the SoS of the phalanges. We recruited 91 post-menopausal women, aged 55-75 years, who were divided in three groups according to their lumbar bone mineral density (BMD) and the existence of prevalent vertebral fractures. The objective was to evaluate the diagnostic sensitivity of SoS measurements. We used DBM Sonic 1200 equipment, and assessed the velocity at which US cross the phalanx in a lateral-medial direction. In post-menopausal women, BMD was measured by dual energy X-ray absorptiometry (DXA) at the level of the lumbar spine, the total zone of the non-dominant hip and the femoral neck zone of the non-dominant hip. RESULTS: The precision of the SoS measurements was 0.71+/-0.05% (mean+/-S.E.M) whereas the reproducibility was 0.95+/-0.06%. Subjects with low BMD or prevalent fractures had significantly lower values of SoS (P < 0.001) than the controls. ROC curve analysis applied to the study population confirmed that SoS was able to discriminate between the controls and osteoporotic subjects (area under the ROC curves were 0.82 (low bone mineral density) and 0.85 (prevalent fractures), respectively). Hip BMD was found to be the most significant variable when comparing the controls and the low density patients by stepwise discrimination and SoS significantly improved the discrimination between the groups when added to the hip BMD. The hip BMD was again the most discriminant variable when applying the same techniques to controls and patients with prevalent fractures, followed by SoS and lumbar BMD. A cut-off value of 1881 m/s is defined for SoS by logistic discrimination and likelihood ratio function. With this value, the sensitivity and the specificity for SoS used in the diagnosis of established osteoporosis were, 81.5% and 79.3%, respectively. Sensitivity and specificity were significantly improved when combining ultrasonometry and densitometry. CONCLUSION: Measurement of ultrasound velocity at the phalanges appears to be a precise and reproducible technique. SoS discriminates between normal post-menopausal women and patients with either low lumbar BMD or prevalent fractures to the same extent as BMD measurements. [less ▲]

In vitro models for the study of cartilage damage and repair

in Rheumatology in Europe (1998), 27(S2), 7

L’INF gamma est un inhibiteur puissant de la synthèse d’IL-8 par les chondrocytes humains

in Revue du Rhumatisme (1998), 11

IFN gamma inhibits IL-8 production by IL-1bêta and TNFalpha stimulated human chondrocytes

in Revue du Rhumatisme (English ed.) (1998), 11

Which test for which patient ?

in Osteoporosis International (1998), 8(S3), 152

The Bland and Altman method adapted to quality control of dual-energy X-ray absorptiometry

in Osteoporosis International (1998), 8(S3), 64

Parathyroid hormone plasma concentration in response to low 25-OH vitamin D circulating levels increase with age in elderly women

in Osteoporosis International (1998), 8(S3), 40

What is the role of bone forming agents ?

in Osteoporosis International (1998), 8(S3), 4

Regulatory role of nitric acid (NO) in chondrocyte responses to cytokines

in BONE (1998), 23(S5), 344