St George's University Hospitals NHS Foundation Trust

3. Mrs A complains that in December 2021 St George’s University Hospitals NHS Foundation Trust (the Trust) planned a yearly treatment plan of zoledronate infusions, and then started this in April 2022, without telling her about all the risks or offering her alternative treatment.

4. Mrs A broke her teeth January 2024, and her dentist told her the infusions put her at high risk of osteonecrosis of the jaw (ONJ) and failed dental implants. She says she cannot get the dental treatment she needs, which now affects her daily life. The Trust’s actions have caused her considerable distress because she could not give informed consent for the infusions.

5. Mrs A wants the Trust to acknowledge what it got wrong. She wants it to offer her a formal apology and £10,000 compensation for the impact of the failings. She also wants it to make service changes to ensure this does not happen to someone else.

6. Mrs A had a bone density scan which showed significant osteoporosis (fragile bones from loss of tissue and an increased risk of sustaining fractures. She had other existing comorbidities such as persistent heartburn regurgitation which led to reflux. The Trust decided an intravenous (IV) zoledronate infusion every 12 months for three years was most suitable. It would review the plan after this course.

7. After receiving two doses between 2022 and 2023, she had a fall in January 2024, which led to her needing dental work. Mrs A’s dentist told her the infusions put her at higher risk of developing osteonecrosis of the jaw (ONJ). She relayed this to the Trust, and it was agreed to withhold the final infusion due to the risks associated with the treatment. It suggested once she had the dental treatment, she returns for another bone scan and treatment plan based on those results.

Informed consent to treatment

12. Before we decide if we should do a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not found sufficient evidence to say something went wrong here.

13. Mrs A says the Trust did not make her aware of all the risks associated with the treatment it offered her. She acknowledges she was referred for a dental check-up, but she does not think this alone substituted the comprehensive discussion they should have had on the risks of receiving the infusions.

14. The Trust says it did discuss this with Mrs A at the beginning of her consultation in October 2021. It says the clinician involved specifically discussed ONJ risks ahead of making the referral. It says its consideration of dental risks was further supported by an electronic medical note on 12 April 2022 where the clinician noted the outcome of the dental visit as generally good.

15. We have looked at what the records tell us. The Trust’s consultation clinic letter (December 2021) said it had discussed risks, effects and contraindications – there is no more specific detail here. Mrs A’s notes also say the Trust gave her an information leaflet with more details on the risks associated with the infusions. But the records are not explicit in what it discussed.

16. It is also not clear if the Trust’s leaflet was about osteoporosis or zoledronate. When we asked the Trust to give us a copy of the leaflet it said it no longer had the one it used that year. We also asked Mrs A, but said she never received a leaflet. However, we appreciate this is in the context of us asking for it four to five years after the fact.

17. Our role is to weigh up the available evidence and make an independent decision. When we do this here, it is difficult for us to know what specific information the Trust gave Mrs A.

18. We can see the Trust considered the dental risks when it asked her to get a dental check-up ahead of the treatment. This is what the NICE guidance says should happen before treatment and this would indicate there was some discussion or consideration about the link between the treatment and dental health. There is insufficient evidence for us to conclusively say these discussions were as explicit or comprehensive as they should have been. But we also cannot say the Trust did not consider the risks at all.

19. When we weigh up the evidence, we do not think we could make a firm decision if we considered this part of the complaint further.

20. So, we next looked at whether there were any realistic alternative treatment options for Mrs A.

Alternative treatments

21. Mrs A says there were other lower risk treatments the Trust should have explored before offering her zoledronate infusions. The infusions put her at higher risk of ONJ which affected her ability to get dental treatment when she later damaged her teeth.

22. The Trust says a fracture liaison nurse explored different options. They discussed hormone replacement therapy (HRT) treatment with her and explained why this was not suitable given the severity of her osteoporosis. Mrs A’s records and bone density scans show she had osteoporosis and earlier fractures.

23. Our adviser said the Trust was right when it explained that HRT would not have been suitable for Mrs A. She had significant osteoporosis and HRT is typically more suitable for younger patients. They confirmed this is not the go to treatment when other more suitable options have not been explored first. We asked our adviser whether based on Mrs A’s presentation there were any other alternative treatments that may have been suitable. They said in line with NICE and NOGG guidance, oral or IV bisphosphonates were best due to the nature of her osteoporosis.

24. Our adviser suggested the next lower risk option was oral bisphosphonates (the same group of drugs as zoledronate). Mrs A’s records show she had a history of heartburn and gastroesophageal reflux. This is mentioned in the clinic letter with her other diagnoses and is also recorded in the GP records on several occasions in 2009, 2016 and later in 2022. She was taking medications for this condition.

25. The NICE guidance suggests this may have made her an unsuitable candidate for oral treatment because it can make heartburn and reflux symptoms worse. But this is only speculation as there is nothing in the records to suggest the Trust explored this option at the time. Our adviser said the evidence does not suggest there was a complete contraindication to oral treatment.

26. When we weigh up the evidence, there is a possibility this was another treatment option the Trust could have considered but did not. So, we next thought whether we can say Mrs A would have avoided the problems getting dental treatment she later had if she had been offered and taken oral treatment.

27. Our adviser first explained that ONJ after IV bisphosphonate treatment is a significant complication but very rare. They said while the infusions do carry a higher risk of ONJ, oral medication also carries the risk of ONJ. There is a cumulative risk for both oral and IV treatment, particularly when taken over a few years.

28. Our adviser said the risks to dental treatment reduce after stopping oral bisphosphonates or sometime after stopping IV treatment. They referred to a clinical study published by Nature.org. This shows over 150,000 osteoporosis participants saw a significant reduction in the risk of them developing ONJ after the medication was discontinued. The most substantial risk reduction was for patients who had stopped it for a year or more.

29. Overall, when we weigh up the evidence, we think the Trust should have discussed oral medications with Mrs A before settling on the infusions. But we cannot say on the balance of probabilities that taking oral medication would have led to a different outcome. There would have been an increased risk of her developing worse symptoms for her heartburn and reflux and would still have been at risk of developing ONJ.

30. Mrs A’s last infusion was June 2023. The Trust recommended she stop infusions, get dental treatment then return for further scans. This advice appears to be in line with the evidence about the risk after stopping medication. It is very unfortunate Mrs A suffered an accident which led to her needing dental work. We cannot say that by the time the Trust advised her to get the work she needed there would have been any significant lasting impact from the last infusion she had 15 months before. We accept her dentist may have had a different opinion.

31. In summary, the available evidence does not allow us to clearly say whether the Trust got things wrong in the consenting process for Mrs A’s treatment, or in its consideration of oral treatment for her. But we know she would have been at risk of ONJ even if she had taken oral medication and the risk remains low even for patients who receive infusions. We can also see what the Trust offered when she needed dental work was in line with the evidence of the risk reduction after stopping medication.

32. We log all complaints, whether upheld or not, and they are crucial to the work we do to influence systemic change. We sincerely want to thank Mrs A for bringing her concerns to us. We recognise she wanted a different outcome, and we hope our findings offer her some reassurance about the care she received.

1. We have carefully considered Mrs A’s complaint about St George’s University Hospitals NHS Foundation Trust (the Trust). There is not enough evidence for us to say whether Trust got something wrong when it gained Mrs A’s consent for treatment. There was an alternative treatment option that there is no evidence the Trust considered. But this also carried a risk of the same complications. Overall, we cannot say the outcome would have been different for her. We do not think considering the complaint further would allow us to reach any firmer conclusions.

2. We are sorry to hear about Mrs A’s experience at the Trust. We recognise this has been an upsetting and distressing time for her and hope the information below clearly explains how we reached our views.