Effects of two oral doses of alendronate in the treatment of Paget's disease of bone

Adami, Silvano; Mian, M.; Gatti, Pietro; Rossini, Maurizio; Zamberlan, N.; Bertoldo, Francesco; Cascio, Vincenzo Lo

doi:10.1016/8756-3282(94)90818-4

Cited by 64 publications

(30 citation statements)

References 7 publications

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“…A dosage of 40 mg rather than 20 mg is most effective for reducing focal lesions in Paget disease. 31,32 Although the possibility that Gaucher-related osteopenia only responds to the high dosages used in this trial (40 mg/d) cannot be formally excluded from this trial, the optimal dosage is likely to be the 10 mg/d regimen typically used for postmenopausal osteoporosis (or its weekly equivalent). Administration of ALN in dosages of more than 10 mg/d had little additive effect in postmenopausal women.…”

Section: Org Frommentioning

confidence: 99%

Gaucher disease: alendronate disodium improves bone mineral density in adults receiving enzyme therapy

Wenstrup

Bailey

Grabowski

et al. 2004

Blood

105

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Symptomatic patients with Gaucher disease (GD) (acid ␤-glucosidase [Gcase] deficiency) are treated with injectable human recombinant GCase. Treatment results in significant decreases in lipid storage in liver, spleen, and bone marrow, but the generalized osteopenia and focal bone lesions present in many adult patients are refractory to treatment. A double-blind, 2-arm, placebo-controlled trial of alendronate (40 mg/d) was performed in adults with GD who had been treated with enzyme for at least 24 months. Primary therapeutic endpoints were improvements in (1) bone mineral density (BMD) and content (BMC) at the lumbar spine, and (2) focal lesions in x-rays of long bones assessed by a blinded reviewer. There were 34 patients with GD type 1 (age range, 18-50 years) receiving enzyme therapy who were randomized for this study. After 18 months, ⌬BMD at the lumbar spine was 0.068 ؎ 0.21 and 0.015 ؎ 0.034 for alendronate and placebo groups, respectively (P ‫؍‬ .001). Long-bone x-rays showed no change in focal lesions or bone deformities in any subject in either arm. Alendronate is a useful adjunctive therapy in combination with enzyme replacement therapy (ERT) for the treatment of GD-related osteopenia in adults, but it cannot be expected to improve focal

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Section: Org Frommentioning

confidence: 99%

Gaucher disease: alendronate disodium improves bone mineral density in adults receiving enzyme therapy

Wenstrup

Bailey

Grabowski

et al. 2004

Blood

105

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“…Alendronate at a dosage of 40 mg/die for 6 months has proven efficacious in reducing disease activity and improving the radiographic picture both in studies comparing it against etidronate and in non-controlled studies (87)(88)(89)(90). Alendronate is not available in Italy in the formulation approved for the treatment of Paget's disease.…”

Section: Alendronatementioning

confidence: 99%

Paget’s disease

et al. 2014

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Paget’s disease of bone is the most common metabolic bone disease after osteoporosis and affects 2-4% of adults over 55 years of age. Its etiology is only partly understood and includes both genetic and environmental factors. The disease may be asymptomatic and can be uncovered incidentally on x-ray or in biochemical tests performed for another condition. It can also manifest itself with bone pain, deformity, fracture or other complications. Paget’s disease is diagnosed by x-rays and in general has very typical radiological features, but occasionally the clinical picture may be unusual and a differential diagnosis of sclerotic or lytic metastases needs to be considered. Plasma total alkaline phosphatase activity is the most clinically useful indicator of disease activity. It is elevated in most untreated patients, but may be within the normal range in patients with monostotic or limited disease. Bisphosphonate therapy is indicated for patients with symptoms and should also be considered in patients with disease sites that suggest a risk of complications, such as long bones, vertebrae or base of the skull. Orthopedic surgery in Paget’s disease patients includes almost exclusively the correction of fractures and arthroplasty.

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“…These agents bind to the bone mineral surface and inhibit osteoclastic bone resorption (1,2). Alendronate sodium (4-amino-1-hydroxybutylidene-1,1-bisphosphonic acid, sodium trihydrate), is a potent amino-bisphosphonate that has undergone extensive clinical development for the treatment of osteoporosis and other skeletal disorders (3)(4)(5)(6)(7)(8). In postmenopausal women with osteoporosis, daily oral alendronate increases bone mineral density of the spine, hip and total body (6,7,9).…”

Section: Introductionmentioning

confidence: 99%

Histomorphometric assessment of the long-term effects of alendronate on bone quality and remodeling in patients with osteoporosis.

Chavassieux¹,

Arlot²,

Reda³

et al. 1997

J. Clin. Invest.

493

333

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Treatment effects on bone quality and remodeling was assessed in postmenopausal women with osteoporosis treated with oral alendronate. One transiliac bone biopsy was obtained from 231 women at either 24 mo ( n ϭ 11) or 36 mo ( n ϭ 120) from the start of treatment with alendronate at doses of between 5 and 20 mg/d, or placebo. 64 biopsies at 24 mo (31 from the placebo group and 33 alendronatetreated patients) and 95 biopsies at 36 mo (40 from the placebo group and 55 alendronate-treated patients) provided adequate cancellous tissue, and were analyzed by histomorphometry. Mineral apposition rate was unaffected by treatment. At 24 and 36 mo, osteoid thickness, volume, and surface significantly decreased. At each of the doses studied, mineralizing surface and activation frequency significantly decreased at each time point (e.g., Ϫ 92% and Ϫ 87%, respectively, for the 10 mg daily dose after 2 yr). These diminutions were of the same magnitude for each dose at 24 mo, and for the two highest doses at 36 mo. A significant increase in wall thickness accompanied by a reduction in erosion depth was detected in biopsies obtained at 24 mo. These findings confirm that mineralization is normal, and trabecular bone turnover markedly decreased in patients receiving long-term dosing with alendronate. The findings also suggest that the observed increases in bone mineral density could result both from a reduction in the remodeling space due to a decreased activation frequency and a possible trend to a positive bone balance. In addition, further studies focused on a possible increase in the degree of mineralization of bone are required. (

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Effects of two oral doses of alendronate in the treatment of Paget's disease of bone

Cited by 64 publications

References 7 publications

Gaucher disease: alendronate disodium improves bone mineral density in adults receiving enzyme therapy

Gaucher disease: alendronate disodium improves bone mineral density in adults receiving enzyme therapy

Paget’s disease

Histomorphometric assessment of the long-term effects of alendronate on bone quality and remodeling in patients with osteoporosis.

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