Trip Answers

Question answered:19/01/08 Warning! this question is over two years old.

The NLH Q&A Service answered a question in October 2007 on examining the evidence for prevention of osteoporosis in elderly men with prostate cancer on Zoladex treatment (1). We have reproduced their answer below.

“In researching this question the only co-morbidity considered was cancer. It should be noted that all bisphosphonates have adverse effects specifically related to certain conditions. More information on these can be found in the PRODIGY (CKS) guidance.

Significantly less studies and guidelines on male prevention and treatment of osteoporosis and lowering of bone density have been published than for women. The PRODIGY (now CKS) 2006 guidance provides a comprehensive summary of those treatment/prevention options that have and have not been tested in men.

A previous NLH Q and A in 2006 answered a similar question and found:

“Concerning the management of patients on androgen deprivation therapy, Holmes-Walker et al writing in the Medical Journal of Australia this year notes:

“The importance of vitamin D and calcium replacement in preventing osteoporosis in patients with prostate cancer should not be overlooked, particularly given an epidemiological association between vitamin D deficiency and prostate cancer risk. Subclinical vitamin D deficiency has been found in 63% of elderly men presenting with hip fracture, compared with 25% in a concurrent hospital-based control group (inpatients and outpatients). ..Given the potential of vitamin D deficiency to exacerbate bone loss, we have summarised recommendations for calcium and vitamin D replacement in men receiving ADT in Box 2 [see full text of article].”

“A randomised study of prostate cancer patients on ADT showed that resistance exercise, consisting of supervised training at least three times per week for 30–60 minutes, improved fatigue, muscle strength and some measures of quality of life. However, in the 12-week exercise period there was no demonstrable effect of exercise on BMD or testosterone level.”

Holmes-Walker et al also consider the role of bisphosphonates in patients on ADT:

“It is clear from the literature on osteoporosis that patients with pre-existing fracture or with a minimal trauma fracture that develops during ADT should be treated with an oral bisphosphonate (in Australia, either alendronate or risedronate). Given the evidence that ADT reduces BMD and increases fracture risk, we propose that bisphosphonate therapy needs to be considered in individuals at high risk of developing fracture, either because of low pre-existing BMD (osteoporotic levels) or with significant loss of BMD while on therapy (ie, levels fall to the osteoporotic range on therapy).”

“The choice of bisphosphonates in those without fracture will vary between individuals and will need to take into account the costs of therapy. The first choice should be an oral bisphosphonate such as alendronate or risedronate, which are currently authorised for use in male osteoporosis with fracture. Where these are not tolerated, reports have shown prevention of bone loss with doses of pamidronate varying between 60 mg at 3-monthly intervals and 90 mg at 6-monthly intervals (Level I evidence), and zoledronate at a dose of 4 mg at 3-monthly intervals (Level II evidence).”

This article also contains a flow chart for monitoring and use of bisphosphonates with ADT. In addition, there is a section on unresolved issues concerning bisphosphonate therapy in ADT.”

The CKS (PRODIGY) guidance suggests, “You can help to keep your bones healthy by: eating foods that are high in calcium; doing exercise such as walking; stopping smoking; avoiding excessive alcohol. Aim to have a pint of milk a day, plus one pot of yoghurt or about 2 oz of hard cheese. If you find it difficult to eat enough calcium in your diet, your doctor can prescribe a calcium supplement for you.”

“However for those with osteoporosis, the guidance states;

There is little evidence on the treatment of osteoporosis in men.

Alendronate currently has the best trial data in terms of effectiveness.

Alendronate, 10 mg daily is licensed for use in men with osteoporosis.

Alendronate, 70 mg weekly is not licensed for use in men, but is likely to have similar efficacy.

A calcium supplement (600 mg to 1.2 g per day) should also be taken, and also vitamin D (400–800 IU) if dietary intake is thought to be inadequate.

Other bisphosphonates are not recommended for first-line treatment of osteoporosis in men — they are not licensed for use in men and there is a lack of data on their effectiveness. However, some experts consider risedronate as a practical alternative in men who are unable to tolerate alendronate.

The warning regarding a rare side-effect of bisphosphonates should be noted, “Rarely, osteonecrosis of the jaw has been reported. For people with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids and poor oral hygiene).”

 

The Commission on Human Medicines has dental recommendation which can also be found in the CKS guidance.”

1. http://www.clinicalanswers.nhs.uk/index.cfm?question=6550

 

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