vitamin-d-2 and Spinal-Fractures

The purpose of this study was to evaluate the effect of calcium and vitamin D2 supplementation on bone mineral density (BMD) in children with inflammatory bowel disease (IBD).. This was an open-label, prospective study conducted over a 12-month period. Seventy-two patients were divided into 2 groups based on lumbar spine areal BMD (L2-4 aBMD). Patients with an L2-4 aBMD z score of -1 or higher were assigned to the control group (n = 33; mean age, 11.0 +/- 3.5 years; 20 boys). Patients with an L2-4 aBMD of less than -1 (n = 39; mean age 11.8 +/- 2.5 years; 25 boys) were allocated to the intervention group and received 1000 mg of supplemental elemental calcium daily for 12 months (n = 19) or supplemental calcium for 12 months and 50,000 IU of vitamin D2 monthly for 6 months (n = 20).. The 2 groups differed in L2-4 aBMD z scores (intervention, -1.9 +/- 0.6; control, -0.2 +/- 0.6; P < 0.001) and volumetric L2-4 BMD (vBMD; intervention, 0.29 +/- 0.04; control, 0.33 +/- 0.06; P < 0.001). After 1 year of therapy, the control and intervention groups had similar changes in height z scores, L2-4 aBMD, L2-4 vBMD (z score change, L2-4 aBMD: control 0.2 +/- 0.6 [n = 21], intervention 0.4 +/- 0.6; P = 0.4 [n = 26]; z score change, L2-4 vBMD: control 0.1 +/- 0.4, intervention 0.2 +/- 0.6; P = 0.74). The changes in these parameters were similar between patients who had received calcium only or calcium plus vitamin D.. These results suggest that, in children with IBD, supplementation of calcium and vitamin D does not accelerate accrual in L2-4 BMD.

Topics: Absorptiometry, Photon; Bone Density; Bone Density Conservation Agents; Calcium; Child; Cohort Studies; Dietary Supplements; Drug Therapy, Combination; Ergocalciferols; Female; Follow-Up Studies; Fractures, Compression; Humans; Inflammatory Bowel Diseases; Male; Prospective Studies; Spinal Fractures; Treatment Outcome

Although fluoride salts have been shown to be capable of linearly increasing spinal bone mineral density (BMD) in postmenopausal osteoporosis, the effects of this gain in density on the vertebral fracture rate remain controversial. We conducted a 2-year multicenter, prospective, randomized, double-masked clinical trial in 354 osteoporotic women with vertebral fractures (mean age 65.7 years). They received either fluoride (208 patients), given as sodium fluoride (50 mg/day) or as monofluorophosphate (200 mg/day or 150 mg/day), or a placebo (146 patients). All patients received daily supplements of 1 g of calcium (Ca) and 800 IU of vitamin D2 (D). A 1-year open follow-up on Ca-D was obtained in 124 patients. After 2 years the fluoride group and the Ca-D group had increased their lumbar BMD by 10.8% and 2.4% respectively (p = 0.0001). However, the rate of patients with at least one new vertebral fracture, defined by semiquantitative assessment and evaluable on an intention-to-treat basis in 89% of patients, was similar in the fluoride groups and the Ca-D group. No difference between the three fluoride regimens was found. The percentage of patients with nonvertebral fractures was not different in the fluoride and Ca-D groups (1.9% and 1.4% respectively for hip fractures). A lower limb pain syndrome occurred more frequently in the fluoride groups. In the 124 patients followed for 1 year after cessation of fluoride therapy, the percentage of patients with at least one new vertebral fracture after 36 months was identical to the percentages in the previous fluoride group and the Ca-D group. We conclude that fluoride-Ca-D regimen was no more effective that Ca-D supplements for the prevention of new vertebral fractures in women with postmenopausal osteoporosis.

Topics: Aged; Bone Density; Calcium; Double-Blind Method; Drug Therapy, Combination; Ergocalciferols; Female; Fluorides; Fractures, Spontaneous; Humans; Middle Aged; Osteoporosis, Postmenopausal; Phosphates; Prospective Studies; Sodium Fluoride; Spinal Fractures; Time Factors

Although vitamin D supplementation in the frail elderly improves calcium absorption, suppresses parathyroid hormone, decreases bone loss and reduces the risk of fractures, such treatment may be ineffective in patients with vertebral osteoporosis, because of impaired vitamin D metabolism or resistance to the action of vitamin D metabolites on the bowel. We have therefore performed a randomized, single masked study comparing the effects of alfacalcidol treatment (0.25 micrograms twice daily) and vitamin D2 supplementation (500-1000 units daily) on calcium absorption and bone turnover in 46 elderly women (median age 69 years, range 64-79 years) with radiological evidence of vertebral fractures. Serum 25-hydroxyvitamin D increased significantly after 3 and 6 months of treatment with vitamin D2 (p < 0.001), but was unchanged in the group receiving alfacalcidol. Serum 1,25-dihydroxyvitamin D did not change significantly in either group over the study period. Fractional 45Ca absorption increased after 3 months of treatment with alfacalcidol (p < 0.05), but was unchanged with vitamin D2. There was also a reduction in plasma intact parathyroid hormone and serum alkaline phosphatase after 6 months of treatment with alfacalcidol (p < 0.05) which was not seen in the group receiving vitamin D2. Our study shows that vitamin D2 supplementation is ineffective in stimulating calcium absorption in elderly women with vertebral osteoporosis. By increasing calcium absorption in such patients, alfacalcidol may prove more effective than vitamin D in the management of vertebral osteoporosis.

Topics: Absorption; Aged; Calcium; Ergocalciferols; Female; Humans; Hydroxycholecalciferols; Prospective Studies; Single-Blind Method; Spinal Fractures; Treatment Outcome

(1) Data on fluoride efficacy in secondary prevention of osteoporotic fractures were contradictory when we last examined the file, in 1990. We now re-examine the clinical file on fluoride with more follow-up and new clinical trial data. (2) In 354 postmenopausal women with a history of vertebral fracture (secondary prevention), a comparative trial (the FAVOS trial) showed that moderate-dose fluoride for 2 years did not reduce the incidence of new vertebral fractures relative to calcium plus vitamin D. Furthermore, fluoride caused more cases of lower-limb pain. (3) In 110 postmenopausal women with a history of vertebral fracture, a trial showed that fluoride (sustained-release form) + calcium was more effective than calcium alone in preventing vertebral fractures. (4) No pertinent trial on fluoride in primary prevention has been published since 1991.

Topics: Aged; Calcium; Double-Blind Method; Drug Evaluation; Drug Therapy, Combination; Ergocalciferols; Female; Fluorides; Fractures, Spontaneous; France; Humans; Middle Aged; Osteoporosis, Postmenopausal; Spinal Fractures; Treatment Outcome

Topics: Bone Density; Calcitriol; Cholecalciferol; Dose-Response Relationship, Drug; Ergocalciferols; Female; Fractures, Spontaneous; Humans; Hydroxycholecalciferols; Hypercalcemia; Osteoporosis, Postmenopausal; Spinal Fractures; Vitamin D