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Osteoporosis experts launch guidance to fill gaps left by NICE

BMJ 2008; 337 doi: https://doi.org/10.1136/bmj.a2204 (Published 21 October 2008) Cite this as: BMJ 2008;337:a2204

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NICE guidance for osteoporosis: women aged over 75 with fragility fractures should have DEXA

The UK National Institute for Health and Clinical Excellence (NICE)
guidance on the management of osteoporosis has generated much controversy
and the publication of “alternative” guidelines by the National
Osteoporosis Guideline Group (NOGG) 1

An aspect of the NICE guidance which has not been debated is the
suggestion that DEXA scanning is not required in women over the age of 75
who have suffered a fragility fracture. This advice has been incorporated
into the Osteoporosis Direct Enhanced Service (DES) agreement for GP’s who
are being advised that such patients “should be offered preventative
treatment with bone sparing drugs” without recourse to further
investigation.

The above guidance is presumably based on the assumption that women
over the age of 75 who have a fragility fracture almost always have
osteoporosis, but so far as we are aware, there is no evidence to show
that this is the case.

In order to determine the frequency of osteoporosis in this patient
group, we studied bone mineral density values as assessed by dual energy X
-ray absorptiometry (DEXA) in female patients age >75 with fragility
fractures who were dealt with by the Lothian and Glasgow fracture liaison
services (FLS) between January and December 2007. During this time, the
Lothian FLS dealt with 367 women over the age of 75 who had suffered
fragility fractures and the Glasgow FLS dealt with 677 women. The
prevalence of osteoporosis (BMD T-score <_-2.5 at="at" either="either" spine="spine" or="or" hip="hip" osteopenia="osteopenia" t-score="t-score" between="between" _-1.0="_-1.0" and="and" _-2.5="_-2.5" normal="normal" bmd="bmd"/>-
1.0) are summarised in the table.

Service	Osteoporosis	Osteopenia	Normal
Lothian (n=367)	145 (39.5%)	138 (37.6%)	84 (22%)
Glasgow (n=677)	376 (51.2%)	252 (40.4%)	49 (8.5%)
Combined (n=1044)	525 (50.1%)	390 (37.2%)	133 (12.7%)

These data show that only than half of women over the age of 75 years
with fragility fractures actually have osteoporosis; a large proportion
have osteopenia and 12% have normal BMD. To suggest that all of these
women should be given osteoporosis treatments is not supported by clinical
evidence since virtually all of the randomised controlled trials of drug
treatments for osteoporosis have evaluated patients with BMD values in the
osteoporotic range as evaluated by DEXA of the spine or hip 2-6 .
Furthermore, there is no evidence that osteoporosis treatments prevent
fractures in patients with osteopenia or normal BMD. For example, in the
fracture intervention trial, alendronate did not reduce the incidence of
fracture significantly in osteopenic women 7. Similarly, in a study with
risedronate, there was no significant reduction in the risk of hip
fracture in elderly women who were selected on the basis of clinical risk
factors alone 8. Calcium and vitamin D supplements which are used widely
as an adjunct to other osteoporosis treatments but similarly ineffective
in the secondary prevention of clinical fractures in elderly patients who
have had a fragility fracture 9.

Our observations demonstrate that adherence to the NICE guidelines
and DES would result in about 50% of elderly patients receiving
osteoporosis treatments for which evidence for benefit is lacking and
which in some cases may cause harm 10-12.

A basic principle of medical care is to administer treatment only
when the benefit outweighs the risk. We suggest that DEXA should be used
to evaluate the likely benefit of osteoporosis therapy in elderly patients
to ensure that treatment is being targeted appropriately.

References

(1) Mayor S. Osteoporosis experts publish new guidelines to fill
gaps left by NICE. Br Med J 2008; 337:a2204.

(2) Liberman UA, Weiss SR, Broll J, Minne HW, Quan H, Bell NH et al.
Effect of oral alendronate on bone mineral density and the incidence of
fractures in postmenopausal osteoporosis. The Alendronate Phase III
Osteoporosis Treatment Study Group. N Engl J Med 1995; 333:1437-1443.

(3) Reginster J, Minne HW, Sorensen OH, Hooper M, Roux C, Brandi ML
et al. Randomized trial of the effects of risedronate on vertebral
fractures in women with established postmenopausal osteoporosis. Vertebral
Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporosis Int
2000; 11(1):83-91.

(4) Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster
JY et al. Effect of parathyroid hormone (1-34) on fractures and bone
mineral density in postmenopausal women with osteoporosis. N Engl J Med
2001; 344(19):1434-1441.

(5) Reginster JY, Seeman E, de Vernejoul MC, Adami S, Compston J,
Phenekos C et al. Strontium Ranelate reduces the risk of nonvertebral
fractures in postmenopausal women with osteoporosis: TROPOS study. J Clin
Endocrinol Metab 2005; 90:2816-2822.

(6) Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA et
al. Once-yearly zoledronic acid for treatment of postmenopausal
osteoporosis. N Engl J Med 2007; 356(18):1809-1822.

(7) Black DM, Thompson DE, Bauer DC, Ensrud K, Musliner T, Hochberg
MC et al. Fracture risk reduction with alendronate in women with
osteoporosis: the Fracture Intervention Trial. FIT Research Group. J Clin
Endocrinol Metab 2000; 85(11):4118-4124.

(8) McClung MR, Guesens P, Miller PD, Zippel H, Roux C, Roux C et
al. Effect of Risedronate on the Risk of Hip Fracture in Elderly Women. N
Engl J Med 2001; 344(5):333-340.

(9) Grant AM, Avenell A, Campbell MK, McDonald AM, MacLennan GS,
McPherson GC et al. Oral vitamin D3 and calcium for secondary prevention
of low-trauma fractures in elderly people (Randomised Evaluation of
Calcium Or vitamin D, RECORD): a randomised placebo-controlled trial.
Lancet 2005; 365(9471):1621-1628.

(10) Bilezikian JP. Osteonecrosis of the jaw--do bisphosphonates
pose a risk? N Engl J Med 2006; 355(22):2278-2281.

(11) Twiss IM, van den Berk AH, de Kam ML, Bosch JJ, Cohen AF,
Vermeij P et al. A comparison of the gastrointestinal effects of the
nitrogen-containing bisphosphonates pamidronate, alendronate, and
olpadronate in humans. J Clin Pharmacol 2006; 46(4):483-487.

(12) Schneider JP. Bisphosphonates and low-impact femoral fractures:
current evidence on alendronate-fracture risk. Geriatrics 2009; 64(1):18-
23.

Competing interests:
SHR acts as a consultant for Proctor & Gamble, Merck and Novartis; Steven J Gallacher has received lecture fees for Eli Lilly, Alastair Mclellan has received lecture fees for Proctor & Gamble.

Competing interests: Service Osteoporosis Osteopenia NormalLothian (n=367) 145 (39.5%) 138 (37.6%) 84 (22%)Glasgow (n=677) 376 (51.2%) 252 (40.4%) 49 (8.5%)Combined (n=1044) 525 (50.1%) 390 (37.2%) 133 (12.7%)

26 May 2009
Stuart H Ralston
Professor of Rheumatology
Gina de&#146;Lara, Stephen J Gallacher, Jim Hannan, Alastair R McLellan
Western General Hospital, Edinburgh EH4 2 XU