Ca&Bone

[Evaluation of quality of life following treatment with calcitonin nasal spray in patients with osteoporosis: preliminary results of the MERLIN study]

BORS Katalin1, KÓSA József2, BORBÉLY Judit2, TABÁK Ádám3, HORVÁTH CSABA3

MAY 20, 2004

Ca&Bone - 2004;7(02)

[INTRODUCTION - MERLIN (Management of Osteoporosis in Elderly with Calcitonin) is an open-label, multicenter, prospective, follow-up study conducted in Hungary, part of which is to assess the impact of treatment with Miacalcic, - an intranasal salmon calcitonin, on the quality of life (QoL) among patients with osteoporosis. In this paper we report the preliminary results of the MERLIN study. PATIENTS - The study initially involved 1949 senior patients (aged >65 years) to whom calcitonin was prescribed for osteoporosis according to the application instructions. Patients presented at outpatient clinics and consisted of two groups; they were either newly diagnosed or they had been receiving a therapy for osteoporosis other than calcitonin. METHODS - This latter group discontinued their previous treatment and all patients received 200 IU intranasal salmon calcitonin (SCT) once daily for three months. Patient and physician questionnaires were used to collect information on the patients' QoL (EQ-5D VAS) and their general well-being at baseline and at follow-up visits at week 4 and week 12. RESULTS - Calcitonin use was associated with improvements in all EQ-5D domains and component scores as well as in VAS. Patients with previously known osteoporosis who, switched to calcitonin therapy achieved better results (0,046 QALY), than the newly diagnosed patients (0,0405 QALY). CONCLUSIONS - We conclude that intranasal SCT 200 IU daily is safe and effective in improving QoL of both, male and female patients with low bone mineral density.The conclusions that can be drawn from this study are limited due to the lack of a control group and to the unblinded design. Further placebo-controlled studies are needed to confirm these results. Nevertheless, our study was the first in Hungary to evaluate the quality of life impact of an osteoporosis treatment, and hopefully it will be followed by more such studies directed to other osteoporosis treatments.]

AFFILIATIONS

  1. Fõvárosi Önkormányzat Visegrádi Rehabilitációs Szakkórháza
  2. Novartis Hungária Kft., Orvosi Osztály
  3. Semmelweis Egyetem, Általános Orvostudományi Kar, I. Sz. Belgyógyászati Klinika, Budapest

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Ca&Bone

[Bone mineral density and diabetes mellitus - First results]

TÕKE Judit, TAMÁS GYULA, STELLA Péter, NAGY Erzsébet, NÁDASDI Ágnes, VARGA Piroska, KERÉNYI ZSUZSA

[INTRODUCTION - Data on bone mineral density (BMD) in diabetes mellitus are contradictory in the literature. Early studies described a decreased bone mineral density in type 1 diabetes mellitus (T1DM), but recent studies report no osteopenia in T1DM.The BMD may depend on the quality of treatment for diabetes mellitus and on the presence of chronic complications. In type 2 diabetes mellitus (T2DM) the BMD is not decreased, occasionally it can even be increased. PATIENTS AND METHODS - Bone mineral density was measured in 122 regularly controlled diabetic patients (T1DM: n=73, mean age: 43.6±11.1 years,T2DM: n=49, mean age: 61.8±9.8 years) by dual energy X-ray absorptiometry at the lumbar spine and at the femur. Results were compared to those of 40 metabolically healthy control persons with a mean age of 47.5±11.9 years.The patients’ carbohydrate metabolism was assessed by the average HbA1c level of the last three years.These values were 7.9±1.4 % in T1DM, and 7.5±1.7 % in T2DM. BMDs were classified based on the T-score and Z-score using the WHO criteria. RESULTS - There was no significant difference in T1DM or in T2DM compared to the reference group in the prevalence of either osteoporosis or of osteoporosis and osteopenia combined. CONCLUSION - BMD was not found to be decreased in patients with well-controlled metabolism compared to healthy controls.]

Ca&Bone

[The role and effects of progestogens in menopausal hormone therapy]

ÁCS Nándor, MERICLI Metin, VERMES Gábor, LANGMÁR Zoltán

[The adequate therapy of postmenopausal hormone deficiency is estrogen replacement. However, the risk of endometrium hyperplasia and carcinoma is significantly increased among users of estrogen as monotherapy.To minimize the risk of endometrial cancer, a progestogen must be added to estrogen therapy. While progestogens may inhibit the cardiovascular effects of estrogens, they do not significantly influence the effects of estrogen on bone. The increased risk of breast cancer among menopausal hormone therapy users seems to be the consequence of progestin administration.There are notable differences among progestins in their effects and side effects, thus, in the future, therapeutic protocols should be tailored individually.The differential effects of various progestogens is an exciting area to study, partly because it may have clinical consequences, partly, because it provides opportunities for far-reaching research.]

Ca&Bone

[István Krasznai, MD]

FÖLDES János

Ca&Bone

[Bone metabolism and body mass index in postmenopausal women]

TÁRCZY Csaba, TOLDY Erzsébet, SZERB János, VARGA László

[INTRODUCTION - In addition to several other causes constitutional factors play an important role in the development of osteoporosis.Various aspects of bone metabolism were examined to explain the differences in bone density between women with low and high body mass index (BMI). PATIENTS AND METHOD - One hundred and ninetytwo postmenopausal women were included in the study. Bone density was measured by forearm densitometry.To assess bone formation, serum osteocalcin levels were measured, while the rate of bone absorption was estimated from C-terminal telopeptide levels of collagen type I measured in urine and blood. RESULTS - The prevalence of osteoporosis was higher in women with low BMI than in those with normal or higher BMI. Bone metabolism - both formation and absorption - was increased in both groups, however, in women with low BMI this increase was more pronounced and bone metabolism tended to be shifted to absorption compared to patients with normal or higher BMI. CONCLUSION - Postmenopausal lean women have accelerated bone metabolism compared to obese women. This fact and the shift to absorption may be the main reasons for the higher frequency of osteoporosis found by densitometry in women with low BMI than in those with higher BMI.]

Ca&Bone

[The role of alfacalcidol in the prevention of osteopenia following renal transplantation]

BERCZI Csaba, ASZTALOS László, KINCSES Zsolt, BALOGH Ádám, LŐCSEY Lajos, BALÁZS György, LUKÁCS Géza

[AIM - The aim of this prospective study was the long-term evaluation of the effect of calcium and alfacalcidol treatment on calcium metabolism in patients with renal transplantation. METHODS - Patients were divided in two groups. Patients in Group 1 (n=159) received calcium substitution, while patients in Group 2 (n=81) were treated with alfacalcidol. Serum Ca, P, Mg, alkaline phosphatase (AP) and PTH levels were determined before and after transplantation regularly for three years. Femur neck and lumbar vertebral bone mineral densities (BMD) were measured at the same time after transplantation. RESULTS - After transplantation the mean serum calcium level significantly increased, while the mean serum phosphate level significantly decreased in both groups. After the operation the PTH levels decreased in both groups and it was found to be more pronounced in the alfacalcidol group.The majority of patients had osteopenia in the follow-up period. Between the third month and the third year after transplantation, BMD increased by 9.4% in Group1, and decreased by 4% in Group 2 at the lumbar spine. At 3 years the mean BMD value at the femoral neck was increased by 6.5% in Group 1, and by 6.7% in Group 2, compared to the 3-month values.The change in BMD was only significant at the lumbar spine, in Group 1 (p=0.019). During the follow-up period osteonecrosis was diagnosed in 6 patients in Group 1 and in 9 cases in Group 2. CONCLUSION - Alfacalcidol treatment decreased secondary hyperparathyroidism more rapidly and effectively, which was also indicated by the more pronounced decrease of serum PTH levels. During the 3 years follow-up period, BMD increased in both groups except for the lumbar spine in Group 2, however, the majority of the patients still had osteopenia.The study could not demonstrate a superiority of alfacalcidol over calcium supplementation in the prevention of posttransplantational osteopenia.]

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Hungarian Immunology

[Molecular mechanisms and clinical importance of the RANK - RANK ligand - osteoprotegerin system]

SZENTPÉTERY Ágnes, BALOGH Ádám, VARJÚ Tibor, SZEKANECZ Zoltán

[The receptor activator of nuclear factor κB ligand (RANKL) is an essential cytokine for the formation and activation of osteoclasts. RANK, expressed on osteoclasts, interacts with RANKL, produced by osteoblasts and stromal cells. RANK-RANKL interaction is involved in osteoclastogenesis and bone resorption underlying metabolic bone diseases, arthritis, malignant bone disorders and some vascular diseases. Osteoprotegerin (OPG) physiologically counterbalance the action of RANKL. Several factors including estrogens, citokines and others regulate the RANKL-OPG ratio and thus bone resorption. RANKL blockade using recombinant OPG or anti-RANKL antibody may prevent bone loss in osteoporosis, chronic inflammatory and vascular disorders, as well as tumors. Active vaccination and gene therapy are further future perspectives in therapy. All these treatment modalities may be included in the future management of bone and vascular diseases.]

LAM KID

[Forgotten agent: raloxifene]

BENKŐ Ágota

[The largest group of the patients with osteoporosis is postmenopausal women characterized by a state of menopausal hormone deficiency which is results in accelerated bone loss. This increased bone resorption significantly elevates the risk of bone fractures including the most common type, i.e. vertebral fractures. In addition to the increased risk of fractures, estrogen deficiency affects other organs, thus, increasing the incidence of cardiovascular diseases, cancers, mood disorders and the symptoms of menopausal syndrome in women after menopause. In postmenopausal osteoporosis, the primary objective is to maintain the existing bone mass, a priority for the prevention and treatment of bone fractures. Hormone deficiency may be prevented by the administration of estrogen but the treatment may have adverse effects such as increased risk of endometrial cancer. An etiological therapy is desirable where the compound used for treatment exerts effects similar to that of estrogen to prevent postmenopausal bone loss as well as reduces the risk of cardiovascular disease without the stimulation of reproductive tissues.]

LAM KID

[Is a paradigm shift possible in the clinical practice of preventing recurrent fractures?]

TAKÁCS István

[Recurrent osteoporotic bone fractures are less and less considered “natural”, due to the immense variety of products available for treatment. In order to prevent recurrent fractures, treatment should be started in time, and a careful approach is needed to choose the appropriate treatment, and, if needed, to switch therapy. When choosing the therapeutic approach, we have to decide whether it corresponds to the severity of the osteoporosis and the risk of fracture. In order to do this, we have to consider bone quality, previous fractures, the condition of cortical bones and the mode of action of the selected treatment, in addition to the easily evaluated density value. The aim of this article is to provide practical help for the above mentioned decisionmaking process.]

Ca&Bone

[Vitamin D receptor gene BsmI polymorphism in rheumatoid arthritis and associated osteoporosis - Experimental data]

RASS Péter és munkatársai

[AIM: Rheumatoid arthritis (RA) is commonly associated with secondary osteoporosis.The BsmI polymorphism of the vitamin D receptor (VDR) gene has been implicated in the pathogenesis of osteoporosis. However, little data is available on the relationship between rheumatoid arthritis and the BsmI polymorphism. In this study, Hungarian frequencies of BsmI polymorphism genotypes were compared with those found in other countries. METHODS: In this study, 64 RA patients and 40 healthy controls were tested for VDR gene BsmI polymorphism genotypes.The frequencies of the B and b alleles were correlated with densitometric and laboratory markers of bone metabolism as well as with laboratory markers of arthritis. RESULTS: Among control subjects, the frequency of the BB genotype (27,5%) was relatively higher than in other European populations. In RA patients with secondary osteopenia/osteoporosis the BB genotype was rarer, while the bb was more common than in control subjects. Markers of bone metabolism showed that the presence of the B allele in RA patients was associated with a lower bone mineral density and an increased bone loss, while the bb genotype was associated with a higher bone mineral content. An increased osteoclast and osteoblast activity was observed in patients with the B allele, as determined by biochemical markers of bone metabolism. Rheumatoid factor titer, an important laboratory marker of disease progression in RA, was significantly higher in bb patients compared to patients carrying the B allele. CONCLUSION: Our data suggest that the imbalance in B and b allele expression may be involved in the pathogenesis of osteoporosis and perhaps of rheumatoid arthritis.]

LAM KID

[Efficiency of osteoporosis treatment in Hungary - An analysis of the Hungarian National Insurance Company’s data]

LAKATOS Péter, TÓTH Emese, SZEKERES László, POÓR Gyula, HÉJJ Gábor, TAKÁCS István

[The treatment of osteoporosis and its consequences place a significant burden on the health care of developed countries. Modern therapeutical approaches are able to efficiently decrease the risk of osteoporotic bone fractures. However, we do not know whether the interventions introduced in the past 15 years have significantly reduced the number of osteoporotic fractures in real life, and if they have, how cost-effective this effect was. To answer these questions, we have analysed data of the Hungarian National Insurance Company collected between 2004-2010. During these 7 years, the number of bone fractures among patients treated for osteoporosis continuously decreased. This was also observed in the incidence of hip fractures. Interestingly, the mortality of osteoporotic patients was significantly lower than that of the same age group in the average population. Besides the efficient treatment of osteoporosis, this finding is also due to the outstanding general care provided by the specialised osteoporosis centers of the country. As a consequence of the reduction in fractures, 3.4 billion HUF was saved per year by the insurance company, which is approximately equal to the 3.5 billion HUF spent on the reimbursement of medicines used for the treatment of osteoporosis, which means that the investments show a return. The calculation of the quality- adjusted life years, which is the internationally accepted method of the WHO for the study of cost-effectiveness, shows that the above results were achieved in a remarkably cost-efficient way. At the same time, it is noteworthy and calls for caution that the decrease in reimbursement by the insurance company in 2007 resulted in a 51% drop in the number of patients receiving treatment, which radically reduced the observed efficiency.]