This is a plain English summary of an original research article
This systematic review found that bisphosphonate drugs, taken for at least six months, improved bone density and lowered fracture risk in men with low bone density, compared with a placebo or supplements (calcium alone or with vitamin D). Bisphosphonates have been extensively researched for treating women with low bone density after the menopause, but this was the first review to look at their use in men. Significantly, the review looked not only at bone density measurements, but also at fracture rates - an important outcome for older at-risk men. Cost-effectiveness was not considered, but hip fractures alone cost the NHS about £2 billion a year, so prevention is likely to lead to cost savings.
Why was this study needed?
Osteoporosis is a common condition that affects around 3 million people in the UK, The bones of those affected gradually lose density and become more fragile and brittle, raising the risk of fractures. A frequent cause of osteoporosis is age-related hormonal changes, such as after the menopause, and so research on bisphosphonate drugs – drugs that slow down or prevent bone damage - for osteoporosis has tended to focus on older women.
However, about a quarter of hip fractures occur in men, and mortality after hip fracture is higher in men than women; about 20% after one year. Just a few trials have measured how well bisphosphonate drugs improve bone density in men, but very little research has recorded fractures rates.
This was the first systematic review to look at bisphosphonate drugs to treat osteoporosis and prevent fractures in men.
What did this study do?
This was a systematic review of nine randomised controlled trials including 2,464 men with low bone density. The trials looked at 6 to 36 month long treatments using one of the four bisphosphonate drugs available – alendronate, risedronate, zoledronate or ibandronate. The control treatment was either a placebo (two trials) or Vitamin D alone or alongside calcium supplements (seven trials). Zolendronate was given by annual injection, the other drugs were taken as tablets.
Of the nine trials seven were rated as high quality and two as moderate quality. The studies used different definitions of low bone density, and different approaches to adding calcium and vitamin D supplements, but nonetheless, the results appear reliable.
What did it find?
Compared with taking placebo or supplements (calcium alone or with vitamin D):
- bisphosphonate treatment reduced the risk of spinal fracture by nearly two thirds (six trials; relative risk (RR) 0.36, 95% confidence interval (CI) 0.24 to 0.56), and non-spinal fracture by a half (five trials, RR 0.52, 95% CI 0.32 to 0.84). The time period this was measured over, or baseline risk of fracture, was not reported.
- bisphosphonate treatment increased bone mineral density in all three parts of the skeleton assessed, the lower spine, the hip and top of the thigh bone, and at all times points: 6, 12 and 24 months (seven trials).
- the rate of new bone formation increased in men taking bisphosphonates.
What does current guidance say on this issue?
UK national guidance from the National Osteoporosis Guideline Group (updated 2014) recommends weight-bearing exercise, stopping smoking, alcohol moderation and a diet containing sufficient calcium and vitamin D for all people with osteoporosis, including men. As well as lifestyle changes, taking a bisphosphonate drug is recommended as the first choice of medical treatments for those at high risk of fracture.
NICE guidance from 2008 on the effectiveness of drugs to prevent and treat osteoporosis focuses on post-menopausal women. The scope of future NICE guidance will include treating men, and updated NICE recommendations on using bisphosphonates to prevent osteoporosis are due to be published in November 2015.
What are the implications?
This systematic review consolidates existing evidence from nine trials showing that the same drugs used to treat low bone density and prevent fractures in women also work in men. The findings are in line with 2014 UK National Osteoporosis Guideline Group guidance.
Osteoporosis is an important health issue in older men, but many don’t get treatment. There is a lack of UK-based guidance on the effectiveness of bisphosphonate drugs for treating men with osteoporosis, so new guidance from NICE, due in November 2015, will be of particular interest to those affected, as well as practitioners and commissioners.
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