The effect on bone mass and bone markers of different doses of ibandronate: A new bisphosphonate for prevention and treatment of postmenopausal osteoporosis: A 1-year, randomized, double-blind, placebo-controlled dose-finding study

Ravn, Pernille; Clemmesen, B; Riis, Bente Juel; Christiansen, Claus

doi:10.1016/s8756-3282(96)00229-3

Cited by 150 publications

(55 citation statements)

References 34 publications

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“…Interestingly, the mean improvements in lumbar spine and proximal femur BMD (i.e. 3.35 and 1.18%, respectively) are in line with results from international clinical trials [4,8], suggesting that clinical effects of ibandronate in Central American postmenopausal women might be similar to those from other parts of the world. These results might have also depended on the administration of the bisphosphonate with vitamin D and calcium, which may have helped to boost the clinical effects of the drug.…”

Section: Discussionsupporting

confidence: 79%

“…Ibandronate efficacy and safety have been demonstrated in several clinical trials [3,4,5,6,7,8,9]. Even if this drug is commonly used in Central America, to the best of our knowledge, its clinical effects have never been studied before in patients from this region.…”

Section: Discussionmentioning

confidence: 99%

“…Biphosphonates are the most frequently used antiresorptive pharmacological therapy [2]. Ibandronate is a third-generation nitrogen-containing bisphosphonate with recognized antiresorptive efficacy in several international, randomized, double-blind, controlled trials [3,4,5,6,7,8,9]. To the best of our knowledge, antiresorptive activity of the drug has never been explored in Central America, even though the drug is widely used in the region.…”

Section: Introductionmentioning

confidence: 99%

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Clinical Effects of a 6-Month Treatment Course of Ibandronate, Vitamin D, and Calcium in Postmenopausal Women from Central America: Results of a Multinational, Prospective Pilot Study

Gutierrez¹,

Codina

Pinel

et al. 2016

Integr Med Int

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Background/Aims: To explore the effects of ibandronate plus a supplementation of vitamin D and calcium on bone mineral density (BMD) and health-related quality of life (HRQoL) in a sample of postmenopausal women from Central America. Secondarily, factors related to the magnitude of improvements in BMD after treatment were investigated. Methods: Postmenopausal women with idiopathic osteoporosis or at risk of developing it, who were going to start treatment with ibandronate 150 mg once a month plus daily supplementation with vitamin D 400-800 IU and calcium 500-1,000 mg, were followed up for 6 months. BMD, HRQoL (mini-Osteoporosis Quality of Life Questionnaire), and treatment adherence (Morisky scale) were studied before and after treatment. Results: Four hundred and twenty-five women were assessed at baseline, and 308 (72%) were reassessed at month 6. Lumbar spine, proximal femur, and hip BMD increased by 3.35 ± 0.75, 1.88 ± 0.50, and 2.75 ± 0.32%, respectively (p < 0.001 for all). HRQoL total score and emotional functioning, symptoms, physical function, and leisure subscores improved by 26-49% (p < 0.01 in all cases). Lower body mass index, younger age at menopause, use of corticoids, and higher adherence were significantly and independently associated with a greater improvement in lumbar spine BMD (logistic regression). Conclusion: Improvements in BMD and HRQoL after ibandronate, vitamin D, and calcium were observed in patients from Central America, which should be confirmed by double-blind, randomized, controlled trials. Lack of adherence to ibandronate was related to worse outcomes, thus highlighting the need for work on this issue with patients on treatment.

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Section: Discussionsupporting

confidence: 79%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Clinical Effects of a 6-Month Treatment Course of Ibandronate, Vitamin D, and Calcium in Postmenopausal Women from Central America: Results of a Multinational, Prospective Pilot Study

Gutierrez¹,

Codina

Pinel

et al. 2016

Integr Med Int

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“…For example, in a community-based sample of men and women aged 50± 88 years, Schneider et al [30] reported signi®cantly lower BMD values at hip and spine in women with increasing quintiles of urinary NTx, as well as signi®cantly lower BMD values at the hip in males with increasing quintiles of urinary NTx values. Ravn et al [35] reported an 8±14% difference in BMD (p < 0.001) between the highest and lowest quintiles of urinary CTx and serum OC in pre-and postmenopausal women. Based on receiver operator characteristic curve (ROC) analyses, Guerrero et al [32] found that urinary Pyr and serum ICTP were of limited discriminatory ability between various BMD groups (e.g., ICTP levels did not differ between osteoporotic women and normal controls, and while Pyr levels did differ, its sensitivity was only 25%).…”

Section: Marker±bmd Relationshipmentioning

confidence: 98%

Clinical Use of Biochemical Markers of Bone Remodeling: Current Status and Future Directions

Looker

Bauer

Chesnut

et al. 2000

Osteoporosis International

223

117

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Biochemical markers of bone turnover provide a means of evaluating skeletal dynamics that complements static measurements of bone mineral density (BMD). This review evaluates the use of commercially available bone turnover markers as aids in diagnosis and monitoring response to treatment in patients with osteoporosis. High within-person variability complicates but does not preclude their use. Elevated bone resorption markers appear to be associated with increased fracture risk in elderly women, but there is less evidence of a relationship between bone formation markers and fracture risk. The critical question of predicting fracture efficacy with treatment has not been answered. Changes in bone markers as currently determined do not predict BMD response to either bisphosphonates or hormone replacement therapy. Single measurements of markers do not predict BMD cross-sectionally (except possibly in the very elderly), or change in BMD in individual patients, either treated or untreated. On the other hand, research applications of bone turnover markers are of value in investigating the pathogenesis and treatment of bone diseases. Markers have potential in the clinical management of osteoporosis, but their use in this regard is not established. Additional studies with fracture endpoints and information on negative and positive predictive value are needed to evaluate fully the utility of bone turnover markers in individual patients.

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“…The main biological effect is a decrement in bone resorption through inhibition of osteoclast activity. The bisphosphonates have been used to treat a variety of disorders characterized by increased bone resorption, including Paget's disease, hypercalcemia, metastatic bone disease, and recently osteoporosis [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23]. Presently, only etidronate and alendronate are approved for osteoporosis treatment.…”

Section: Introductionmentioning

confidence: 99%

A 2-Year Phase II Study with 1-Year of Follow-up of Risedronate (NE-58095) in Postmenopausal Osteoporosis

et al. 1997

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This paper presents the results of a two-center, double-masked, placebo-controlled, randomized, oral-dose study of risedronate treatment in postmenopausal osteoporosis. Patients had at least one, but no more than four prevalent vertebral fractures at baseline. They received either 2.5 mg continuous risedronate, 2.5 mg cyclic risedronate, or placebo for 2 years. Both risedronate and placebo were formulated as hard gelatin capsules. All women furthermore received a daily calcium supplement of 1 g which was taken separately from the study drug. During the 1-year of follow-up, all women received only a daily calcium supplement of 1 g. A total of 132 patients were enrolled (44 in each treatment group), of which 73% completed the 2-year treatment period and 70% all 3 years. Generally the outcome of the study was negative. Lumbar spine bone mineral density (BMD) increased 1.2% (NS) and 0.8% (NS) and after 2 and 3 years in the group treated with continuous risedronate, 1.7% (NS) and 2.3% (p < 0.05) in the group treated with cyclic risedronate, and 0.6% (NS) and 1.7% (NS) in the placebo group. BMD in the femoral neck increased 2.9% (p < 0.05) and 0.9% (NS) after 2 and 3 years in the group treated with continuous risedronate, 1.3% (NS) and 2.4% (p < 0.01) in the group treated with cyclic risedronate, and 1.3% (NS) and 2.6% (p < 0.01) in the placebo group. The differences between all three groups in spinal and femoral BMD after 2 years were not statistically significant, but reached statistical significance after 3 years (p < 0.01) in the femoral neck. Only minor changes were observed in the measured markers of bone turnover. Both the incidence and rate of new vertebral fractures showed no overall differences between the groups. The distribution of adverse events was similar across treatment groups. None of the serious adverse events were considered causally related to risedronate. The lack of effect shown in the present study may be explained by insufficient dose regimen and/or impaired absorption from the intestinal tract. Further investigations (ongoing phase III trials) are needed to define future dose regimens in order to validate the effect on bone mass, fracture rate and biochemical markers. In these studies another formulation of the drug and other dosing instructions are used.

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The effect on bone mass and bone markers of different doses of ibandronate: A new bisphosphonate for prevention and treatment of postmenopausal osteoporosis: A 1-year, randomized, double-blind, placebo-controlled dose-finding study

Cited by 150 publications

References 34 publications

Clinical Effects of a 6-Month Treatment Course of Ibandronate, Vitamin D, and Calcium in Postmenopausal Women from Central America: Results of a Multinational, Prospective Pilot Study

Clinical Effects of a 6-Month Treatment Course of Ibandronate, Vitamin D, and Calcium in Postmenopausal Women from Central America: Results of a Multinational, Prospective Pilot Study

Clinical Use of Biochemical Markers of Bone Remodeling: Current Status and Future Directions

A 2-Year Phase II Study with 1-Year of Follow-up of Risedronate (NE-58095) in Postmenopausal Osteoporosis

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