L Meurmans

A 5‐year controlled randomized study of prevention of postmenopausal trabecular bone loss with nasal salmon calcitonin and calcium

Abstract. The aim of this paper was to evaluate the long‐term (5 years) efficacy of nasal salmon calcitonin in prevention of trabecular postmenopausal bone loss, which was a follow‐up of a previously published study (3 years); a randomized, controlled group comparison. One hundred healthy postmenopausal women were randomly chosen from those (186) having completed the 3 year protocol. The 100 women were allocated to an additional 2 year period (total of 5 years) of treatment with either 500 mg d‐1, 5 days week‐1 of calcium or the same amount of calcium plus 50 IU d‐1, 5 days per week of nasal salmon calcitonin, 87 (87%) women complied with the protocol throughout. The main outcome measures were the bone mineral density of the lumbar spine (1‐BMD) (DPA) and biochemical parameters reflecting bone turnover (serum alkaline phosphatases, urinary calcium/creatinine and hydroxyproline/creatinine ratios). The women receiving calcium alone presented a significant decrease in 1‐BMD after 6 months [– 1·6 (0·5)%] [mean(SEM)] (P < 0·01) and this decrease remained significant after 36 months [– 6·1(0·8)%] (P < 0·01) and until the end of the trial [– 6·6(1·0)% at t60] (P < 0·01). In women receiving calcium and calcitonin, 1‐BMD significantly increased after 36 months [+ 2(0·7%] (P < 0·01) and 42 months [+ 2·5(0·7)%] (P < 0·01) and was unchanged at the other times of investigation [+ 1·1(1·1)% at t60] (NS). The evolution of BMD in the two groups was highly significantly different (P < 0·001) since the sixth month of the study and remained so until the end of the study. No differences were observed in the biochemical parameters reflecting bone turnover. Nasal administration of salmon calcitonin, using a low‐dose (50 IU d‐1), intermittent (5 days week‐1) regimen, may totally prevent postmenopausal bone loss, at the level of the lumbar spine, for at least 5 years, if the treatment is continued for this duration. It is not clear whether the results observed during the fourth and fifth years are fully attributable to calcitonin or if calcium by itself plays also a protective role against trabecular bone loss.

Acute changes in serum calcium and parathyroid hormone circulating levels induced by the oral intake of five currently available calcium salts in healthy male volunteers.

SummarySeveral calcium supplements are currently available and many of them are marketed without proper comparison of the bioavailability of the actual preparations. The aim of the present trial was to evaluate and compare the acute changes in serum calcium (Ca) and parathyroid hormone (PTH) levels following the oral administration of a vehicle and of five calcium salts currently prescribed in Western Europe. No significant changes in serum Ca or PTH levels were observed after administration of the vehicle. All calcium salts induced significant increases in serum Ca and decreases in serum PTH compared to baseline values. Comparison of the six response curves revealed a significantly greater increase in serum Ca and a greater decrease in serum PTH after each of the calcium salts than observed after the vehicle. However, no statistically significant differences were observed between the different calcium salts for serum Ca increments. The decrease in serum PTH observed after administration of an ossein-hydroxyapatite complex was significantly less important than after the four other calcium salts, even if statistically different than after vehicle. When assessing the area under the curve (AUC) of PTH values, we observed that calcium carbonate and citrate induce a significantly greater decrease in serum PTH than the other calcium salts which are, however, statistically more active than the vehicle. Serum PTH is decreased under the lower limit of the normal range (10 pg/ml), between t60 and t120 for calcium carbonate and citrate and between t60 and t90 for calcium gluconolactate while the mean PTH values remain within the normal range throughout the study with calcium pidolate, the ossein-hydroxyapatite complex and the vehicle. In conclusion, all calcium preparations significantly increase serum calcium and decrease serum parathormone, compared to what is observed after oral intake of a vehicle. However, significant differences in suppression of parathormone are observed between the different calcium preparations and might be of importance for their clinical use.

Monofluorophosphate decreases vertebral fracture rate in postmenopausal osteoporosis: a randomised, placebo-controlled, double blind study

BONE MASS IN POSTMENOPAUSAL WOMEN Passed M., Int. Med. Inst., Universit. Ipnfiavone (Ip) has been shown to affect bone metabolism mainly by inhibiting bone resorption. A multicentre study was aimed at evaluating the effects of a long-term (3 years) treatment with Ip in postmenopausal women (PMVV) with low bone mass. 141 PMW aged 50-65 years, having a baseline radial bone mineral density (BMD) value <1 SD compared to age-matched, healthy women, and giving their informed consent were randomly allocated to receive either oral Ip (3x200 mglday) or a matched placebo (PI) for 2 years according to a double-blind (db.), parallel group design. At the end of the 2-year d.b. period, all patients received in open fashion for 1 year Ip at the same dosage. A 1 gtday oral calcium supplementation was given during the whole 3-year period to all patients. Serial measurements (every 6 months) of radial BMD (DPA), urinary hydrexyproline/creatinine (HOP/c0 and haematology and blood chemistry parameters were performed. 93 women completed the 3-year treatment, 50 treated with Ip from baseline to month 36 (T36) , of Parma, Italy (group A), and 43 receiving PI from baseline to T24, and then Ip from T24 to T36 (group B). Results on BMD are shown in the figure.