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Use of combined calcitonin and etidronate in bone mass loss with HIV-infection
ABSTRACTS / Bone 38 (2006) S65 – S87
S67
the decompression hole using a tube. Systemic zoledronate treatment was started postoperatively with monthly 4 mg injections. Results: At two-year follow-ups MRI shows no evident collapse and no obvious progression of the necrosis is seen. Clinically, the patient retains good hip function with no hip pain or reduction of walking distance. This is uncommon and unlikely two years after diagnosed osteonecrosis of the hip in Juvenile Chronic Arthtritis patients (Kobayakawa et al., 1989). Conclusion: Follow up continues and a later need of hip arthroplasty can occur, but even if this treatment regime only accomplished a delay in the indication of a joint prosthesis it can be considered successful.
opened in November 2005 and aims to recruit approximately 1400 patients.
doi:10.1016/j.bone.2006.01.007
Background: Control of HIV infection is becoming better and paitents lived longer. With menopause a lot of women undergone osteoporosis. Women with HIV infection has got more riks to osteoporosis which is a big silent disease. Objective: To determine if the combined use of calcitonin and etidronate influences on bone mass loss. Material and method: We studied for 12 months 21 women who were 42 to 57 years old at base line, were within 1 and 6 years of menopause, and had a bone mineral density at the lumbar spine between 146 mg/cc and 75 mg/cc measured by the QBMAP system with a spiral CT Picker PQ-S densitometer at L2, L3, L4 and L5. Of all the women, 10 were assigned to 10 mg of etidronate 15 days in three moths basis, 800 IU of vitamin D3 and 1 g of calcium carbonate supplementation. 11 were treated with 10 mg of etidronate15 days in three moths basis, 200 UI of intranasal calcitonin, 800 IU of vitamin D3 and 1 g of calcium carbonate supplementation. The SPSS programme was used for statiscal analysis. Results: The characteristics of the women recruited for both groups were similar. Mean mineral bone density at the lumbar spine was between 1 and 3 DS below the mean value for 25 years old normal premenopausal women. After a treatment of 12 months no statistically significant difference was found among both groups as for the bone mineral density at the lumbar spine. Conclusions: It is necessary to carry out a wider and longer study, amongVIH-patient, but it seems that etidronate contribute advantages to decrease bone mass loss, at least, at lumbar spine, without calcitonin. This results can be interesting for VIHinfected, who are on a lot of medication.
62 Zoledronic acid versus ibandronate comparative evaluation in breast cancer patients with bone metastases: The NCRI zice trial P.J. Barrett-Lee a, N. Murray b On behalf of the National Cancer Research Institute ZICE Trial Management Group a Velindre Cancer Centre, Cardiff, UK b Cancer Research UK Clinical Centre, University of Southampton, Southampton, UK Bone metastases often have severe and debilitating consequences in metastatic breast cancer (MBC) patients. Ibandronate, a single-nitrogen, non-cyclic bisphosphonate, has demonstrated similar skeletal-related event (SRE) risk reductions to zoledronic acid in MBC patients. In a recent randomized comparison, both agents reduced levels of bone turnover markers (prognostic for SREs) to a similar extent. The availability of oral and intravenous formulations with similar efficacy makes ibandronate an attractive treatment option as this enables treatment flexibility and eliminates the need for inconvenient hospital visits. In phase III trials, the renal safety profile of ibandronate was comparable to placebo. The aim of the ZICE study is to compare the efficacy, safety, and patient satisfaction of daily oral ibandronate 50mg with intravenous zoledronic acid every 3 –4 weeks in MBC patients with newly diagnosed bone metastases. The standard zoledronic acid dose will be 4mg, although because of renal safety issues, doses will be adjusted according to creatinine clearance. The trial is designed to demonstrate the non-inferiority of ibandronate to zoledronic acid across SRE endpoints. ZICE is a randomized, parallel group, multicenter, open-label, 96-week phase III trial. The primary endpoint is the frequency and timing of SREs (multiple-event analysis), and secondary endpoints include time and prevalence of SREs, pain/analgesic-use scores, and adverse event monitoring. Renal function assessments will be performed in all patients according to zoledronic acid product labeling. A serum marker sub-study is planned. The ZICE trial
doi:10.1016/j.bone.2006.01.008
63 Use of combined calcitonin and etidronate in bone mass loss with HIV-infection A. Bazarra-Ferna´ndez Department of Ob Gyn. Juan Canalejo University Hospital, La Corun˜a, Spain
doi:10.1016/j.bone.2006.01.009
64 Cellular immunity in dialysis patients treated with ibandronate for 48 weeks R. Bergner, B. Weiss, M. Hoffmann, D.M. Henrich, M. Uppenkamp Medizinische Klinik A, Klinikum Ludwigshafen, Germany Background: Acute phase reactions are common after intravenous infusion of bisphosphonates. Changes in the cellular immune system, particularly in lymphocyte subtypes, may be
S67
the decompression hole using a tube. Systemic zoledronate treatment was started postoperatively with monthly 4 mg injections. Results: At two-year follow-ups MRI shows no evident collapse and no obvious progression of the necrosis is seen. Clinically, the patient retains good hip function with no hip pain or reduction of walking distance. This is uncommon and unlikely two years after diagnosed osteonecrosis of the hip in Juvenile Chronic Arthtritis patients (Kobayakawa et al., 1989). Conclusion: Follow up continues and a later need of hip arthroplasty can occur, but even if this treatment regime only accomplished a delay in the indication of a joint prosthesis it can be considered successful.
opened in November 2005 and aims to recruit approximately 1400 patients.
doi:10.1016/j.bone.2006.01.007
Background: Control of HIV infection is becoming better and paitents lived longer. With menopause a lot of women undergone osteoporosis. Women with HIV infection has got more riks to osteoporosis which is a big silent disease. Objective: To determine if the combined use of calcitonin and etidronate influences on bone mass loss. Material and method: We studied for 12 months 21 women who were 42 to 57 years old at base line, were within 1 and 6 years of menopause, and had a bone mineral density at the lumbar spine between 146 mg/cc and 75 mg/cc measured by the QBMAP system with a spiral CT Picker PQ-S densitometer at L2, L3, L4 and L5. Of all the women, 10 were assigned to 10 mg of etidronate 15 days in three moths basis, 800 IU of vitamin D3 and 1 g of calcium carbonate supplementation. 11 were treated with 10 mg of etidronate15 days in three moths basis, 200 UI of intranasal calcitonin, 800 IU of vitamin D3 and 1 g of calcium carbonate supplementation. The SPSS programme was used for statiscal analysis. Results: The characteristics of the women recruited for both groups were similar. Mean mineral bone density at the lumbar spine was between 1 and 3 DS below the mean value for 25 years old normal premenopausal women. After a treatment of 12 months no statistically significant difference was found among both groups as for the bone mineral density at the lumbar spine. Conclusions: It is necessary to carry out a wider and longer study, amongVIH-patient, but it seems that etidronate contribute advantages to decrease bone mass loss, at least, at lumbar spine, without calcitonin. This results can be interesting for VIHinfected, who are on a lot of medication.
62 Zoledronic acid versus ibandronate comparative evaluation in breast cancer patients with bone metastases: The NCRI zice trial P.J. Barrett-Lee a, N. Murray b On behalf of the National Cancer Research Institute ZICE Trial Management Group a Velindre Cancer Centre, Cardiff, UK b Cancer Research UK Clinical Centre, University of Southampton, Southampton, UK Bone metastases often have severe and debilitating consequences in metastatic breast cancer (MBC) patients. Ibandronate, a single-nitrogen, non-cyclic bisphosphonate, has demonstrated similar skeletal-related event (SRE) risk reductions to zoledronic acid in MBC patients. In a recent randomized comparison, both agents reduced levels of bone turnover markers (prognostic for SREs) to a similar extent. The availability of oral and intravenous formulations with similar efficacy makes ibandronate an attractive treatment option as this enables treatment flexibility and eliminates the need for inconvenient hospital visits. In phase III trials, the renal safety profile of ibandronate was comparable to placebo. The aim of the ZICE study is to compare the efficacy, safety, and patient satisfaction of daily oral ibandronate 50mg with intravenous zoledronic acid every 3 –4 weeks in MBC patients with newly diagnosed bone metastases. The standard zoledronic acid dose will be 4mg, although because of renal safety issues, doses will be adjusted according to creatinine clearance. The trial is designed to demonstrate the non-inferiority of ibandronate to zoledronic acid across SRE endpoints. ZICE is a randomized, parallel group, multicenter, open-label, 96-week phase III trial. The primary endpoint is the frequency and timing of SREs (multiple-event analysis), and secondary endpoints include time and prevalence of SREs, pain/analgesic-use scores, and adverse event monitoring. Renal function assessments will be performed in all patients according to zoledronic acid product labeling. A serum marker sub-study is planned. The ZICE trial
doi:10.1016/j.bone.2006.01.008
63 Use of combined calcitonin and etidronate in bone mass loss with HIV-infection A. Bazarra-Ferna´ndez Department of Ob Gyn. Juan Canalejo University Hospital, La Corun˜a, Spain
doi:10.1016/j.bone.2006.01.009
64 Cellular immunity in dialysis patients treated with ibandronate for 48 weeks R. Bergner, B. Weiss, M. Hoffmann, D.M. Henrich, M. Uppenkamp Medizinische Klinik A, Klinikum Ludwigshafen, Germany Background: Acute phase reactions are common after intravenous infusion of bisphosphonates. Changes in the cellular immune system, particularly in lymphocyte subtypes, may be