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Articles

Summary of NICE guidance for Osteoporosis – fracture risk / Bisphosphonates

14 November 2020This edition of NICE Bites reflects current NICE guidance (as at November 2020) but the NICE guideline on assessing fracture risk is being updated. Please…

Can oral bisphosphonates be given to people with renal impairment to treat osteoporosis?

9 July 2020In the main, bisphosphonates are not metabolised and are excreted unchanged in urine. Oral bisphosphonates are licensed for the primary and secondary prevention of osteoporotic…

Is there an interaction between bisphosphonates and proton pump inhibitors?

21 June 2019This updated Medicines Q&A evaluates the evidence for an interaction between bisphosphonates and proton pump inhibitors.  
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New Medicines

Aclasta (EU), Reclast (US)Corticosteroid-induced osteoporosis in children

Information

Aclasta (EU), Reclast (US)
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
May 20 It appears that paediatric extension study 2337E1 was conducted as part of a post-licensing requirement and data submitted to EMA for information only, in accordance with article 46. Section 5.1 of SPC has been updated and states that Aclasta should not be used in children and adolescents below 18 years of age. There are no data available for children under 5 years of age. Currently available data for children aged 5 to 17 years are described in section 5.1 (from two studies - 2337E1; NCT00799266 and long-term extension NCT01197300). The SPC also states that there is no clear evidence establishing a link between BMD changes and fracture prevention in children with growing skeletons and long-term safety data in this population cannot be established from these studies [10, 11].

Category

Bisphosphonate
Osteoporosis in children may be primary due to an intrinsic bone abnormality (usually genetic in origin) or secondary due to an underlying medical condition and/or its treatment. One cause is osteogenesis imperfecta which has an estimated incidence of 1 in 10 000–20 000 births; another is idiopathic juvenile osteoporosis with an estimated incidence of 1 in 100 000 [5].
Corticosteroid-induced osteoporosis in children
Intravenous infusion

Trial or other data

May 20Data from PIII study (NCT00799266) shows that Zoledronic acid infusion resulted in an increase in the lumbar spine BMD Z-score least square (LS) mean difference of 0.41 at month 12 relative to baseline compared to placebo (95% CI: 0.02, 0.81; 18 and 16 patients, respectively). No effect on lumbar spine BMD Z-score was evident after 6 months of treatment. At month 12, a statistically significant (p<0.05) reduction in three bone turnover markers (P1NP, BSAP, NTX) was observed in the zoledronic acid group as compared to the placebo group. No statistically significant differences in total body bone mineral content were observed between patients treated with zoledronic acid versus placebo at 6 or 12 months. No new vertebral fractures were observed in the zoledronic acid group as compared to two new fractures in the placebo group. Data from PIII study (NCT01197300) shows no new clinical fractures were observed. However 2 patients, one in each of the core study treatment groups (zoledronic acid group: 1/9, 11.1% and placebo group: 1/14, 7.1%), had new morphometric vertebral fractures. There were no new safety findings [10].

Osteoarthritis of the knee with bone marrow lesions

Information

New formulation
Axsome Therapeutics
Axsome Therapeutics

Development and Regulatory status

None
None
None
Mar 20Axsome is not currently developing AXS-02 (zoledronic acid) [8].

Category

Potent osteoclast inhibitor - reduces osteoclast activity by inhibiting the farnesyl pyrophosphate synthase (FPPS) enzyme
About 6% of adults aged 30 have frequent knee pain and radiographic evidence of osteoarthritis (OA). Symptomatic knee OA affects 12% of people over the age of 65.
Osteoarthritis of the knee with bone marrow lesions
Oral