Search

Sato Y, Iwamoto J, Honda Y, Amano N. Ther Clin Risk Manag. 2013;9:171–176. The Editor and Publisher of Therapeutics and Clinical Risk Management wish to retract the published article. Following publication of the Expression of Concern, this article has been retracted due to acknowledgement of allegations of scientific misconduct regarding data integrity, inappropriate authorship, duplicate reporting, ethical oversight, and data fabrication. In addition, it has been recognised that numerous other publications from this research group have also been retracted. Our decision-making was informed by our policy on publishing ethics and integrity and the COPE guidelines on retraction. The retracted article will remain online to maintain the scholarly record, but it will be digitally watermarked on each page as “Retracted”.

Iwamoto J, Sato Y, Uzawa M, Takeda T, Matsumoto H. Therapeutics and Clinical Risk Management. 2010;6:593–600.The Editor-in-Chief and Publisher of Therapeutics and Clinical Risk Management wish to issue an Expression of concern for the above published article.The Journal Editors received notification from an investigator raising concerns about the published paper. These concerns relate to the high similarity in content to the article ‘Experience with alendronate treatment for 7 years among Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures’. Iwamoto J, Uzawa M. Clinical Rheumatology. 2016;35:205–212. There were also concerns raised relating to the timeline for study conduct and manuscript preparation. The article reports the study took place between July 1st and September 30th, 2010 and was submitted for publication on Oct 24, 2010.Dove Medical Press attempted to contact the authors of the article and their affiliated institution regarding these concerns but received no response. As we were unable to make a definitive conclusion, we would like to alert readers to these issues and allow them to draw their own conclusions. This decision follows the recommendations of the Committee on Publication Ethics (COPE).The Editor and Dove Medical Press make every effort to ensure publication ethics are upheld and are committed to supporting the high standards of the Therapeutics and Clinical Risk Management journal.Read the original article&nbsp

We report the 5-year follow-up of a young woman who developed vertebral fractures after pregnancy and lactation and was treated with active vitamin D hormone. A 32-year-old Japanese woman consulted us because of acute lower back pain caused by L2 and L5 vertebral fractures after pregnancy and lactation. Following cessation of breast-feeding, analgesia, bed rest, and wearing of a hard brace, her lower back pain disappeared within 2 months. After 5 years of treatment with alfacalcidol 1 μg daily, the lumbar spine (L1, L3, L4) bone mineral density increased by 21.4% following vigorous reductions in bone turnover markers. No osteoporotic fractures occurred, and the vertebral fractures healed. The patient experienced no side effects, including hypercalcemia. Thus, the present case report shows long-term changes in bone turnover markers and lumbar spine bone mineral density, as well as long-term safety of alfacalcidol treatment in a young woman with pregnancy and lactation-associated osteoporosis and vertebral fractures.

Jun Iwamoto1 Yoshihiro Sato2 Mitsuyoshi Uzawa3 Tsuyoshi Takeda1 Hideo Matsumoto11Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo; 2Department of Neurology, Mitate Hospital, Fukuoka; 3Department of Orthopaedic Surgery, Keiyu Orthopaedic Hospital, Gunma, JapanPurpose: A retrospective study based on a conventional medical practice was performed to evaluate the outcome of alendronate treatment for four years in Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures.Methods: Twenty-nine Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures (mean age at baseline 61.0 years) who had been treated with alendronate for over four years in our outpatient clinic were studied. Lumbar spine or total hip bone mineral density (BMD) was measured using dual energy x-ray absorptiometry, and urinary levels of cross-linked N-terminal telopeptides of type I collagen (NTX) and serum levels of bone-specific alkaline phosphatase were monitored during the four-year treatment period.Results: Urinary NTX and serum bone-specific alkaline phosphatase levels decreased (-44.4% at three months and -61.2% at four years, respectively) and lumbar spine and total hip BMD increased (+13.9% and +9.2% at four years, respectively), compared with baseline values. No serious adverse events were observed, including osteonecrosis of the jaw, femoral diaphysis atypical fractures, or atrial fibrillation.Conclusion: To our knowledge, this is the first report of the outcome of alendronate treatment for four years in Japanese men with an increased risk for fractures. Alendronate suppressed bone turnover and increased lumbar spine and total hip BMD from baseline over the course of the four-year treatment period without causing any severe adverse events in Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures.Keywords: alendronate, bone mineral density, fracture risk, men, osteoporosis, osteopenia

Jun Iwamoto1, Mitsuyoshi Uzawa2, Yoshihiro Sato3, Tsuyoshi Takeda1, Hideo Matsumoto11Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, Japan; 2Department of Orthopaedic Surgery, Keiyu Orthopaedic Hospital, Gunma, Japan; 3Department of Neurology, Mitate Hospital, Fukuoka, Japan Abstract: The antiresorptive drug elcatonin (ECT) is known to relieve pain in postmenopausal women with osteoporosis. A prospective open-labeled trial was conducted to compare the effects of short-term combined treatment with alendronate (ALN) and ECT on bone mineral density (BMD) and bone turnover with those of single treatment with ALN in postmenopausal women with osteoporosis. Two hundred and five postmenopausal osteoporotic women (mean age: 70 years) were recruited in our outpatient clinic. Forty-six women with back pain were treated with ALN and ECT (intramuscular, 20 units a week), and 159 women without obvious back pain were treated with ALN alone. The lumbar BMD, urinary levels of cross-linked N-terminal telopeptides of type I collagen (NTX), and serum levels of alkaline phosphatase (ALP) were measured during the six-month treatment period. The baseline characteristics, except for age, body weight and number of patients with prevalent vertebral fractures, were not significantly different between the two groups. The mean increase rate in the lumbar BMD at six months was similar in the ALN (+4.41%) and ALN+ECT (+5.15%) groups, following similar reduction rates in urinary NTX levels (-40.2% and -43.0%, respectively, at three months) and serum ALP levels (-19.0% and -19.7%, respectively, at six months). These results were consistent even after adjustments for age, body weight, and number of patients with prevalent vertebral fractures. The present study in postmenopausal osteoporotic women confirmed that the effects of short-term combined treatment with ALN and ECT on lumbar BMD and bone turnover in patients with back pain appeared to be comparable to those of single treatment with ALN in patients without obvious back pain.Keywords: alendronate, elcatonin, osteoporosis, postmenopausal women, back pain

Jun Iwamoto1, Yoshihiro Sato2, Mitsuyoshi Uzawa3, Tsuyoshi Takeda1, Hideo Matsumoto11Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, Japan; 2Department of Neurology, Mitate Hospital, Fukuoka, Japan; 3Department of Orthopaedic Surgery, Keiyu Orthopaedic Hospital, Gunma, JapanPurpose: Combined treatment with alendronate and alfacalcidol is more useful to increase bone mineral density (BMD) than alendronate or alfacalcidol alone. A retrospective study was conducted to investigate the 3-year outcome of combined treatment with alendronate and alfacalcidol in patients with severe bone loss (BMD ≤ 50% of the young adult mean) and osteoporotic fracture.Methods: Thirty-four patients (six men and 28 postmenopausal women) with primary or secondary osteoporosis who had been treated with alendronate and alfacalcidol for more than 3 years were analyzed. The lumbar spine or total hip BMD and bone turnover markers were monitored, and the incidence of osteoporotic fractures was assessed.Results: The urinary level of cross-linked N-terminal telopeptides of type I collagen and serum level of alkaline phosphatase significantly decreased (-42.5% at 3 months and -18.9% at 3 years), and the lumbar spine BMD, but not the total hip BMD, significantly increased (14.8% at 3 years), compared with the baseline values. However, the incidence of vertebral and nonvertebral fractures was 26.5% and 2.9%, respectively, suggesting a high incidence of vertebral fractures.Conclusion: The results of the present study suggest that combined treatment with alendronate and alfacalcidol may be useful to reduce bone turnover and increase the lumbar spine BMD in patients with severe bone loss and osteoporotic fracture. However, its efficacy against vertebral fractures appears not to be sufficient. Thus, anabolic agents such as teriparatide should be taken into consideration as first-line drugs in patients with severe osteoporosis.Keywords: osteoporosis, fragility fracture, bone mineral density, bone turnover

Jun Iwamoto1, Yoshihiro Sato2, Mitsuyoshi Uzawa3, Tsuyoshi Takeda1, Hideo Matsumoto11Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, Japan; 2Department of Neurology, Mitate Hospital, Fukuoka, Japan; 3Department of Orthopaedic Surgery, Keiyu Orthopaedic Hospital, Gunma, JapanAbstract: A retrospective study was performed to evaluate the outcome of alendronate (ALN) treatment for seven years in postmenopausal Japanese women with osteoporosis. Forty-seven postmenopausal women with osteoporosis (mean age at baseline 65.7 years) treated with ALN for over seven years in our outpatient clinic were analyzed. Lumbar spine bone mineral density (BMD) was measured using dual energy X-ray absorptiometry, and urinary levels of cross-linked N-terminal telopeptides of type I collagen (NTX) and serum alkaline phosphatase (ALP) were monitored during the seven-year treatment period. Urinary NTX and serum ALP levels decreased (-48.2% at three months and -15.7% at seven years, respectively) and lumbar spine BMD increased (+12.8% at seven years) compared with baseline values. No serious adverse events were observed, including osteonecrosis of jaw, atypical femoral diaphysis fractures, or atrial fibrillation. To our knowledge, this is the first report of the outcome of ALN treatment for seven years in Japanese patients with osteoporosis. ALN successfully suppressed bone turnover and increased lumbar spine BMD from the baseline value over the course of the seven-year treatment period without causing any severe adverse events.Keywords: alendronate, osteoporosis, long-term treatment, bone mineral density, bone turnover

Jun Iwamoto,1 Yoshihiro Sato21Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, Japan; 2Department of Neurology, Mitate Hospital, Fukuoka, JapanAbstract: An open-label randomized controlled trial was conducted to clarify the effect of eldecalcitol (ED) on body balance and muscle power in postmenopausal osteoporotic women treated with bisphosphonates. A total of 106 postmenopausal women with osteoporosis (mean age 70.8 years) were randomly divided into two groups (n=53 in each group): a bisphosphonate group (control group) and a bisphosphonate plus ED group (ED group). Biochemical markers, unipedal standing time (body balance), and five-repetition chair-rising time (muscle power) were evaluated. The duration of the study was 6 months. Ninety-six women who completed the trial were included in the subsequent analyses. At baseline, the age, body mass index, bone mass indices, bone turnover markers, unipedal standing time, and chair-rising time did not differ significantly between the two groups. During the 6-month treatment period, bone turnover markers decreased significantly from the baseline values similarly in the two groups. Although no significant improvement in the unipedal standing time was seen in the ED group, compared with the control group, the chair-rising time decreased significantly in the ED group compared with the control group. The present study showed that ED improved the chair-rising time in terms of muscle power in postmenopausal osteoporotic women treated with bisphosphonates.Keywords: osteoporosis, fall, vitamin D, muscle power, body balance

Yoshihiro Sato,1 Jun Iwamoto,2 Yoshiaki Honda,1 Nobuko Amano3 1Department of Neurology, Mitate Hospital, Tagawa, Japan; 2Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, Japan; 3Department of Food and Nutrition, Tezukayama University, Nara, Japan Purpose: Vitamin D supplementation is suggested to reduce the risk of falls in older institutionalized or ambulatory individuals by 20%. The present study was undertaken to address the reduced risk, by vitamin D supplementation, of falls and hip fractures in patients with vascular Parkinsonism (VP) and Parkinson’s disease (PD). Patients and methods: In the open-label-study, 94 elderly patients with VP and 92 age-matched patients with PD were followed for 2 years. All patients received 1200 IU ergocalciferol daily. The number of falls per person and incidence of hip fractures were compared between the two groups. Results: At baseline, serum 25-hydroxyvitamin D (25-OHD) levels were in the deficient range (

We report the 11-year follow-up of a man with osteogenesis imperfecta type I who was treated with bisphosphonates and alfacalcidol. A 36-year-old Japanese man with osteogenesis imperfecta type I who had frequently experienced painful fragility fractures consulted our clinic because of chronic back pain. The patient had multiple morphometric vertebral fractures and a low bone mineral density (BMD) at the lumbar spine. The patient was treated with cyclical etidronate 200 mg, for 2 weeks every 3 months, plus alfacalcidol 1 μg daily, for 2 years; and alendronate 5 mg daily or 35 mg weekly, plus alfacalcidol 1 μg daily for 9 years. After 11 years of treatment, BMD at the lumbar spine increased by 6.4%, following a 20.3% reduction in serum alkaline phosphatase. Serum calcium, phosphorus, and intact parathyroid hormone levels remained within the normal ranges. Three clinical fractures occurred at two ribs and the metacarpus, and two morphometric vertebral fractures occurred at the thoracic spine during the 11-year treatment period, but the patient experienced no adverse effects. Thus, the present case report shows the long-term outcome and safety of bisphosphonate plus alfacalcidol treatment in a man with osteogenesis imperfecta type I.

Jun Iwamoto,1 Tetsuya Takada,2 Yoshihiro Sato,3 Hideo Matsumoto11Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, 2Department of Internal Medicine, Hiyoshi Medical Clinic, Kanagawa, 3Department of Neurology, Mitate Hospital, Fukuoka, JapanPurpose: The influence of alendronate (ALN) treatment on the quantitative ultrasound parameters of the calcaneus remains to be established in Japanese patients. The aim of the present clinical practice-based observational study was to examine the influence of ALN treatment for 1 year on the speed of sound (SOS) of the calcaneus and bone turnover markers in postmenopausal Japanese women with osteoporosis.Patients and methods: Forty-five postmenopausal Japanese women with osteoporosis who had received treatment with ALN for more than 1 year were enrolled in the study. The SOS and bone turnover markers were monitored over 1 year of ALN treatment.Results: The urinary levels of cross-linked N-terminal telopeptides of type I collagen and serum levels of alkaline phosphatase decreased significantly from the baseline values (–44.9% at 3 months and –22.2% at 12 months, respectively). The SOS increased modestly, but significantly, from the baseline value (0.6% at both 6 and 12 months). The percentage decrease in the urinary levels of cross-linked N-terminal telopeptides of type I collagen at 3 months was significantly correlated with the percentage increase in the SOS only at 6 months (correlation coefficient, 0.299).Conclusion: The present study confirmed that ALN treatment suppressed bone turnover, producing a clinically significant increase in the SOS of the calcaneus in postmenopausal Japanese women with osteoporosis.Keywords: postmenopausal osteoporosis, quantitative ultrasound (QUS), SOS, bone turnover, biochemical markers

We report the case of a 30-year-old Japanese woman with anorexia nervosa and vertebral fractures who was treated with etidronate. She had a history of anorexia nervosa, chronic back pain, osteoporosis, and multiple vertebral fractures (morphometric fractures) that responded poorly to treatment with alfacalcidol (1 μg daily) for 1 year and was treated with cyclical etidronate (200 mg for 2 weeks every 3 months) for 7 years. The lumbar spine bone mineral density (BMD) increased, and the serum alkaline phosphatase and urinary cross-linked N-terminal telopeptides of type I collagen levels and back pain decreased. During the 7-year period of treatment with etidronate, no osteoporotic fractures occurred. The patient experienced neither renal dysfunction nor hyperparathyroidism caused by osteomalacia. No gastrointestinal tract symptoms were observed. Thus, etidronate was effective for increasing the lumbar spine BMD and reducing back pain over a 7-year period without causing either osteoporotic fractures or adverse events.

Jun Iwamoto1, Atsushi Miyata2, Yoshihiro Sato3, Tsuyoshi Takeda1, Hideo Matsumoto11Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, Japan; 2Department of Internal Medicine, Yahata Clinic, Tokyo, Japan; 3Department of Neurology, Mitate Hospital, Fukuoka, JapanAbstract: A retrospective study was conducted to evaluate the outcome of treatment with alendronate (ALN) for 5 years in postmenopausal Japanese women with an increased risk of fractures. Forty postmenopausal Japanese women with osteoporosis or osteopenia and clinical risk factors for fractures (mean age: 75.4 years) were analyzed; 33 patients were treated with alendronate and 7 were treated with alfacalcidol (ALF, controls) in an outpatient clinic run by general practitioners. The metacarpal bone mineral density (BMD) measured using a computed X-ray densitometer, urinary levels of cross-linked N-terminal telopeptides of type I collagen (NTX), and serum levels of alkaline phosphatase (ALP) were monitored during the 5-year treatment period. The urinary NTX and serum ALP levels decreased significantly in the ALN group, compared with the ALF group. The metacarpal BMD was sustained in the ALN group but decreased significantly in the ALF group; the difference between these two groups was also significant. The present study evaluated the outcome of treatment with ALN for 5 years in postmenopausal Japanese women with osteoporosis or osteopenia and clinical risk factors for fractures. ALN successfully suppressed bone turnover and sustained the metacarpal BMD over the 5-year period of treatment in postmenopausal Japanese women with an increased risk of fractures.Keywords: alendronate, osteoporosis, osteopenia, risk factors for fractures, postmenopausal women