Long-term administration of quarterly IV ibandronate is effective and well tolerated in postmenopausal osteoporosis: 5-year data from the DIVA study long-term extension

Bianchi, Gerolamo; Czerwiński, E. J.; Kenwright, Andrew; Burdeska, A.; Recker, Robert R.; Felsenberg, Dieter

doi:10.1007/s00198-011-1793-9

Cited by 48 publications

(26 citation statements)

References 36 publications

(42 reference statements)

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“…Changes in BMD at the 1/3 radius have been shown to be limited with many antiresorptives ; however, a statistically significant increase in BMD of the 1/3 radius was observed with denosumab treatment, compared with risedronate treatment, at month 24. The treatment difference for BMD at each skeletal site was larger at month 24 than at month 12, reflecting the progressive increase for most measures of BMD in the denosumab group versus the plateau in the risedronate group beyond 12 months, which has also been shown in other studies .…”

Section: Discussionsupporting

confidence: 79%

“…However, inconvenient dosing regimens and potential side effects of bisphosphonates can lead to low adherence in patients with osteoporosis . Furthermore, the increase in bone mineral density (BMD) with bisphosphonate therapy plateaus after 3–4 years . Teriparatide may also reduce fracture risk in those taking glucocorticoids , but daily injections and restriction to a 2‐year lifetime for treatment limit its use.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Denosumab Versus Risedronate in Glucocorticoid‐Induced Osteoporosis: Final Results of a Twenty‐Four–Month Randomized, Double‐Blind, Double‐Dummy Trial

Saag

Pannacciulli

Geusens

et al. 2019

Arthritis & Rheumatology

114

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Objective Clinical trial results have shown that, in glucocorticoid‐treated patients, treatment with denosumab 60 mg subcutaneously once every 6 months (Q6M) increased spine and hip bone mineral density (BMD) at month 12 significantly more than treatment with risedronate 5 mg orally once daily (QD). The present analysis was performed to compare efficacy and characterize safety through month 24. Methods This phase III study enrolled men and women ≥18 years old who had received ≥7.5 mg daily prednisone or equivalent for <3 months (glucocorticoid‐initiating) or for ≥3 months (glucocorticoid‐continuing) before screening. All patients <50 years old had a history of osteoporotic fracture. Glucocorticoid‐continuing patients ≥50 years old had T scores of −2.0 or less (or −1.0 or less with fracture history). Patients were randomized (1:1) to receive denosumab 60 mg subcutaneously Q6M or risedronate 5 mg orally QD for 24 months, with daily calcium and vitamin D. Results Of 795 patients, 590 (74.2%) completed the study (in the glucocorticoid‐initiating group, 109 of 145 patients treated with denosumab and 117 of 145 patients treated with risedronate; in the glucocorticoid‐continuing group, 186 of 253 patients treated with denosumab and 178 of 252 patients treated with risedronate). Denosumab was superior to risedronate in increasing lumbar spine and total hip BMD at all time points assessed, among glucocorticoid‐initiating patients (24‐month lumbar spine: BMD increase of 6.2% versus 1.7%, respectively [P < 0.001]; 24‐month total hip: BMD increase of 3.1% versus 0.0% [P < 0.001]) and among glucocorticoid‐continuing patients (24‐month lumbar spine: BMD increase of 6.4% versus 3.2% [P < 0.001]; 24‐month total hip: BMD increase of 2.9% versus 0.5% [P < 0.001]). Adverse events, serious adverse events (including infections), and fractures were similar between treatment groups. Conclusion Denosumab was superior to risedronate in terms of increases in spine and hip BMD through month 24, and the safety profile was similar between treatment groups. Denosumab may offer a new osteoporosis treatment option for glucocorticoid‐treated patients.

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Section: Discussionsupporting

confidence: 79%

Section: Introductionmentioning

confidence: 99%

Denosumab Versus Risedronate in Glucocorticoid‐Induced Osteoporosis: Final Results of a Twenty‐Four–Month Randomized, Double‐Blind, Double‐Dummy Trial

Saag

Pannacciulli

Geusens

et al. 2019

Arthritis & Rheumatology

114

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“…The range of symptoms that included specific (e.g., myalgia) and nonspecific (e.g., back pain, headache) AE terms were evaluated by onset and duration. The incidence of these symptoms was higher with ibandronate 1 mg than with oral risedronate, possibly due to the different administration routes, but they were reported at a similar frequency to previous studies [1, 9]. Symptoms defined as APR were mild to moderate in intensity, transient and associated with the first administration, as reported in earlier trials of ibandronate in osteoporosis [1, 4].…”

Section: Discussionsupporting

confidence: 74%

“…In the randomized, double-blind trial BONE (oral iBandronate Osteoporosis vertebral fracture trial in North America and Europe), oral ibandronate 2.5 mg/day or 20 mg every other day for 12 doses every 3 months significantly reduced the risk of vertebral fracture and increased bone mineral density (BMD) at the lumbar spine and total hip versus placebo [3]. Two further randomized studies, MOBILE (Monthly Oral iBandronate In LadiEs) [2, 4–6] and DIVA (Dosing IntraVenous Administration) [1, 7–9], confirmed the noninferiority of BMD gains in the lumbar spine with 100 and 150 mg once-monthly tablets or 2 mg/2 months or 3 mg/3 months intravenous (IV) injections to those with daily oral ibandronate 2.5 mg for up to 5 years. The efficacy of ibandronate in increasing BMD in male osteoporosis patients has also been reported [10].…”

mentioning

confidence: 99%

Clinical Efficacy on Fracture Risk and Safety of 0.5 mg or 1 mg/month Intravenous Ibandronate Versus 2.5 mg/day Oral Risedronate in Patients with Primary Osteoporosis

et al. 2013

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This randomized, double-blind study assessed the antifracture efficacy and safety of intermittent intravenous (IV) ibandronate versus oral daily risedronate in Japanese patients with primary osteoporosis. Ambulatory patients aged ≥60 years were randomized to receive 0.5 or 1 mg/month IV ibandronate plus oral daily placebo or 2.5 mg/day oral risedronate, the licensed dose in Japan, plus IV placebo. The primary end point was noninferiority of ibandronate versus risedronate for first new or worsening vertebral fracture over 3 years. A total of 1,265 patients were randomized. A total of 1,134 patients formed the per-protocol set. Both ibandronate doses were noninferior to risedronate: 0.5 mg, hazard ratio (HR) 1.09 [95 % confidence interval (CI) 0.77–1.54]; 1 mg, HR 0.88 (95 % CI 0.61–1.27). The rate of first new vertebral fracture over 3 years was 16.8 % (95 % CI 12.8–20.8) for 0.5 mg ibandronate, 11.6 % (95 % CI 8.2–15.0) for 1 mg ibandronate, and 13.2 % (95 % CI 9.6–16.9) for risedronate. Significant increases in bone mineral density relative to baseline were observed with all treatments after 6 months, with substantial reductions in bone turnover markers after 3 months. Greatest efficacy was obtained with 1 mg ibandronate. Analyses in women only showed similar results to the overall population. No new safety concerns were identified. This study demonstrated the noninferiority of IV ibandronate to the licensed Japanese dose of oral risedronate and suggested that 1 mg/month is an effective dose in Japanese patients with primary osteoporosis.

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“…In most of the studies a maximum five years follow-up is done, although a treatment continuous for ten years is also accepted. Moreover, there are several studies concerning the safety of long term treatments (ten years) [36-42]. With respect to the use of combined therapies (teriparatide and bisphosphonates), it is a usual clinical practice in the osteoporosis treatment [43-47].…”

Section: Methodsmentioning

confidence: 99%

A mechanical model for predicting the probability of osteoporotic hip fractures based in DXA measurements and finite element simulation

et al. 2012

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BackgroundOsteoporotic hip fractures represent major cause of disability, loss of quality of life and even mortality among the elderly population. Decisions on drug therapy are based on the assessment of risk factors for fracture, from BMD measurements. The combination of biomechanical models with clinical studies could better estimate bone strength and supporting the specialists in their decision.MethodsA model to assess the probability of fracture, based on the Damage and Fracture Mechanics has been developed, evaluating the mechanical magnitudes involved in the fracture process from clinical BMD measurements. The model is intended for simulating the degenerative process in the skeleton, with the consequent lost of bone mass and hence the decrease of its mechanical resistance which enables the fracture due to different traumatisms. Clinical studies were chosen, both in non-treatment conditions and receiving drug therapy, and fitted to specific patients according their actual BMD measures. The predictive model is applied in a FE simulation of the proximal femur. The fracture zone would be determined according loading scenario (sideway fall, impact, accidental loads, etc.), using the mechanical properties of bone obtained from the evolutionary model corresponding to the considered time.ResultsBMD evolution in untreated patients and in those under different treatments was analyzed. Evolutionary curves of fracture probability were obtained from the evolution of mechanical damage. The evolutionary curve of the untreated group of patients presented a marked increase of the fracture probability, while the curves of patients under drug treatment showed variable decreased risks, depending on the therapy type.ConclusionThe FE model allowed to obtain detailed maps of damage and fracture probability, identifying high-risk local zones at femoral neck and intertrochanteric and subtrochanteric areas, which are the typical locations of osteoporotic hip fractures.The developed model is suitable for being used in individualized cases. The model might better identify at-risk individuals in early stages of osteoporosis and might be helpful for treatment decisions.

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Long-term administration of quarterly IV ibandronate is effective and well tolerated in postmenopausal osteoporosis: 5-year data from the DIVA study long-term extension

Abstract: Treatment with IV ibandronate 2 mg bimonthly or 3 mg quarterly is effective and well tolerated for up to 5 years in women with postmenopausal osteoporosis.

Cited by 48 publications

References 36 publications

Denosumab Versus Risedronate in Glucocorticoid‐Induced Osteoporosis: Final Results of a Twenty‐Four–Month Randomized, Double‐Blind, Double‐Dummy Trial

Denosumab Versus Risedronate in Glucocorticoid‐Induced Osteoporosis: Final Results of a Twenty‐Four–Month Randomized, Double‐Blind, Double‐Dummy Trial

Clinical Efficacy on Fracture Risk and Safety of 0.5 mg or 1 mg/month Intravenous Ibandronate Versus 2.5 mg/day Oral Risedronate in Patients with Primary Osteoporosis

A mechanical model for predicting the probability of osteoporotic hip fractures based in DXA measurements and finite element simulation

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