Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0030193 (pain)
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A combined therapy with the strongly antiresorptive Alendronate and the pleiotropically acting D-hormone analogue Alfacalcidol may have additive effects on bone quality, falls and fracture risk in established osteoporosis. The aim of this study (Alfacalcidol Alendronate Combined-AAC) was to compare the efficacy and safety of a combined parallel therapy with Alendronate and Alfacalcidol to the treatment with either Alendronate in combination with plain vitamin D or Alfacalcidol alone in patients with established postmenopausal or male osteoporosis. Ninety patients were included as matched triplets to receive randomly either 1 microg Alfacalcidol daily + 500 mg calcium (group A, n = 30) or 70 mg Alendronate weekly + 1,000 mg calcium + 1,000 IU vitamin D daily (group B, n = 30) or 1 microg Alfacalcidol daily + 70 mg Alendronate weekly + 500 mg calcium daily (group C, n = 30). Patients were recruited in one centre and were followed up for 24 months. Analysis was intention-to-treat and the primary outcome was lumbar spine and total hip bone mineral density (measured observer blind). BMD was measured at the lumbar spine and at the proximal femur with dual energy X-ray absorptiometry (LUNAR Prodigy, GE, USA) at the beginning and after 12 and 24 months. During the 2-year-study we observed descriptively significant increases at the lumbar spine of 3.0% in group A compared to baseline, of 5.4% in group B and of 9.6% in group C, respectively. The superiority of the Alendronate + Alfacalcidol treatment group over Alfacalcidol alone and over Alendronate + vitamin D was of more than large rele-vance (both tests: MW > 0.71; CI-LB > 0.64; P < 0.001). We also observed median increases of the BMD at the total hip of 1.5% in group A, of 2.4% in group B and of 3.8% in group C, respectively. The superiority of group C over group A and over group B again was relevant and statistically significant in a descriptive sense. After 2 years there was a tendency towards higher rates of vertebral and non-vertebral fractures in group A and B as compared to C. Taking both fracture types together we observed 9, 10 and 2 "osteoporotic fractures" in groups A, B and C, respectively. The comparison of group C with pooled groups A and B and with each single group gave a relevantly lower fracture rate for the combination of Alendronate and Alfacalcidol. Furthermore a lower rate of falls was observed for the combination Alendronate plus Alfacalcidol versus Alendronate + vitamin D, but not versus Alfacalcidol alone. We found 80% of the patients in the Alendronate + Alfacalcidol group free from back pain at month 24, compared to 30% in the Alendronate + vitamin D and 43% in the Alfacalcidol monotherapy group. The superiority is relevant (both tests: MW > 0.64; CI-LB > 0.56; P < 0.003). Pain decrease also occurred more rapidly in the Alendronate + Alfacalcidol group than in the other groups. In general side effects in all groups were mild, and only four cases of moderate hypercalcuria in group A and one in group C were reported, but no case of hypercalcemia was documented. In conclusion, the combination therapy with Alendronate and Alfacalcidol exhibited superiority in terms of BMD, overall fractures, rate of falls and back pain over either Alendronate in combination with plain vitamin D or Alfacalcidol alone. The overall safety profiles of the three treatment regimens were found to be not different in this study.
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PMID:Superiority of a combined treatment of Alendronate and Alfacalcidol compared to the combination of Alendronate and plain vitamin D or Alfacalcidol alone in established postmenopausal or male osteoporosis (AAC-Trial). 1721 77

This survey of osteoporotic opinion was conducted to 150 Thai physicians in every part of the country with 10 questionnaires. The details of the questions concentrated on the osteoporosis in the aspects of diagnosis, management, methods of assessment, common medicine for treatment. The most responder specialty was Orthopedist (79%), others were Gynecologist (3%), Rheumatologist (5%), Internist (5%), the others (7%) respectively. The diagnosis of osteoporosis used Dual-energy X-ray absorptiometry (DXA), (81%) in the case of this equipment as well as other methods (16%) are available. The per cent of other methods are X-ray, clinical symptoms, microdensitometry, QUS, biochemical bone markers and others: 30, 23, 13, 5, 3 and 6 respectively. About twenty-five percent of physicians took responses to 21-100 cases per month while two per cent of responders had more than 100 cases per month. The most common three ranking kinds of criteria were used for initiating medication for the treatment of osteoporosis that had low bone mineral density, signs of vertebral fracture, and menopause which they considered as the importance of prophylactic medication for patients. The continuation of medication depends on the following factors: experience of serious side effect (62%), affordable expense (53%) and stable bone mass (52%). The desirable features of anti-osteoporosis agents are stopped fracture, increasing BMD, cost effectiveness, side effect, stopped bone resorption, pain relieve and drug compliance respectively. Calcium is most commonly prescribed on condition that premenopausal and postmenopausal women have without fracture or with fracture: patients are elderly and treated with the prolonged steroid application. Bisphosphonates are widely used in case of fracture in every group. Alfacalcidol, vitamin D analog is the third prescription in the above conditions. Bisphosphonate, Calcium and Alfacacidol are the common kinds of combination under the above conditions. In addition, these kinds of drugs are commonly used for continuation after the remission therapy.
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PMID:A survey of osteoporosis in Thailand. 1989 81