NOFSA response to the article “Menopause Matters” by Athol Kent.
Menopause Focus Vol 4 No3, Aug 2016, 15-16
The National Osteoporosis Foundation of South Africa (NOFSA) would like to comment in response to the opinion by Kent published in Menopause Focus, which we feel is imbalanced and misleading in several domains. The controversy raised by Kent mainly concerns 2 areas of contention namely calcium and vitamin D supplementation and the use of pharmacotherapy to prevent fractures. These controversies are fundamentally based on 2 papers by Järvinin and Greg & Bollard. Kent’s opinion paraphrases these articles extensively. The unfortunate part about Kent’s opinion is that he omits to report on published responses to these articles by respected sources such as the International Osteoporosis Foundation (IOF) (available on the NOFSA website www.osteoporosis.org), and thus does not allow the reader to formulate a balanced opinion. For the sake of scientific balance, we now address points raised by Kent.
“Better management of fractures”
NOFSA agrees with this and a joint publication by NOFSA and the South African Geriatrics Society (SAGS) offers local recommendations for patients who have suffered a fracture of the proximal femur.
“Prevention by lifestyle changes”
NOFSA agrees that “most hip fractures occur in people older than 75 years, many of whom are frail or have co-morbidities”. By focussing only on hip fractures Kent greatly undervalues the total benefit of therapy for osteoporosis. Hip fractures constitute only a small percentage of total fractures due to osteoporosis and many of these fractures occur after extremely minor trauma. Spine fractures and non-vertebral non-hip fractures constitute the vast majority of insufficiency fractures in the elderly and are associated with considerable morbidity and even increased mortality. Falls prevention strategies should indeed form part of the clinical assessment of all older patients.
“Prevention by Osteoporosis Diagnosis and Treatment”
Kent states that “it is the trauma of the fall that causes the fracture of their fragile bones” and ”it is the propensity to fall, not bone fragility that predicts fractures”. This begs the question of why babies who fall more than the elderly do not sustain fractures consequent to these falls. We differ from Kent on the following basic principles:
- There is a clear association between low bone mass and fracture risk in post-menopausal women and older men.
- Other risk factors for fracture are important and should be included when assessing individual fracture risk. These risk factors (age, previous fractures, low BMI, smoking, excess alcohol, secondary osteoporosis, glucocorticoids, etc) have been included in various fracture risk algorithms including those advocated by NOFSA and FRAX.
- Randomised clinical trials (RCT’s) have consistently demonstrated efficacy at reducing fractures at spine, hip and non-vertebral sites. RCT’s serve as the gold standard for evidence-based medicine.
- Compston addresses the claim that osteoporosis medications have not been proven to work in the elderly. She offers several explanations for this. In one study subjects were randomised based only on risk factors and not BMD. A second study was not adequately powered to demonstrate fracture efficacy in the older woman. In a third study hip fracture was not a primary endpoint. And a fourth study was grossly underpowered to demonstrate hip fracture efficacy. As stated by Compston “absence of evidence does not constitute evidence for absence of effect”.
- The aim of treatment is the prevention of all fragility fractures as stated above. Analyses from some of the pivotal studies have in fact shown efficacy in this regard in the older patient. Boonen et al analysed pooled data from RCT’s in women 80 years and older and showed an 81% reduction in new vertebral fractures in women treated with risedronate compared to placebo after only 1 year. Analysis of data from 3658 women treated with alendronate showed a consistent relative risk reduction for hip, spine and wrist fractures across all age groups. Boonen et al also showed significant relative risk reduction in all new clinical fractures (35%), clinical vertebral fractures (66%) and non-vertebral fractures (27%) in women >75 years on zoledronic acid compared to placebo enrolled on the Horizon trial.
As stated by IOF
- Osteoporosis is still alarmingly under-diagnosed and undertreated, even after a fragility fracture.
- The elderly are particularly vulnerable where levels of diagnosis and treatment are lowest.
Like the IOF
…NOFSA in its guidelines advocates a systemic approach to fracture prevention which includes lifestyle modification (stop smoking and reduce alcohol), good diet, exercise and fall prevention strategies.
The harsh reality
The vast majority of falls prevention programs have failed to reduce fracture risk. The meta-analysis referred to by Kent which suggests that preventing falls can reduce fracture risk14 is inherently flawed in that most women on the study were under 75 years of age and many did not have risk factors for falling. Extrapolating this data to the frail elderly at high risk of falls and fracture is ill-advised, as a simple exercise program including advice to exercise or walk is extremely hazardous, and if not done under controlled conditions with expert guidance (biokinetics), will serve to increase the risk of falls and fractures.
Measures to prevent falls
…should be an integral part of a fracture prevention program. However, assertions that such measurements are as effective or more effective in preventing fractures as pharmacotherapy is a misrepresentation of current evidence.
The potential of therapeutic harm is overstated by Kent
Patients with active upper gastrointestinal problems should not be prescribed an oral bisphosphonate. In other patients, upper GI adverse events are extremely rare provided the drug is taken in the correct manner. Atypical fractures and osteonecrosis of the jaw (ONJ) are extremely rare complications in patients with osteoporosis treated for <5 years or when the recommended doses for fracture protection are used as opposed to the far higher doses used in oncology.
The Kent statement “there is harm in being treated with drugs of no proven benefit that are not cost-effective and have known side effects” is inaccurate and misleading
An approach to fracture prevention which includes drug therapy has in fact been shown to be cost-effective. Intervention thresholds based on clinical assessment and rational use of guidelines will allow appropriate and cost-effective treatment of those at greatest risk of fracture.
Juliet Compston succinctly states “Editors of academic journals have a responsibility to ensure that published papers are balanced and reflect the available evidence”. This is true of a journal such as Menopause Focus, which is widely read by primary care practitioners and healthcare commissioners who cannot be expected to have in-depth knowledge of specialist topics. We agree with Compston that unbalanced opinions, such as that of Kent, do a disservice to the elderly who suffer fragility fractures and to the scientists and patient organizations that have worked tirelessly over many years to improve their management.
Osteoporosis, calcium & vitamin D
Updated guidelines regarding adequate calcium and vitamin D are available from IOF and NOFSA (www.iofbonehealth.org, www.osteoporosis.org). NOFSA does not advocate routine calcium or vitamin D supplementation. Calcium needs should be met via dietary sources if possible. Our updated guidelines recommend only supplementing calcium (maximum 500mg per day) in those who have osteoporosis or are at risk of fracture and who cannot or will not take adequate calcium in the diet. For vitamin D our guidelines recommend 800IU daily only for those who have osteoporosis or who are at high risk of fracture. The suggestion that doctors are prescribing calcium and vitamin D because of perverse incentives is firmly rejected by NOFSA. Doctors do after all prescribe anti-hypertensives, statins, diabetes medication, anti-depressants and menopausal hormone therapy; all of which are marketed and sold by the pharmaceutical industry. Is Kent suggesting that all pharmaceutical products are prescribed in a perverse manner?
Dr. Stanley Lipschitz, Dr. Tobias De Villiers, Dr. Michael Davey on behalf of the National Osteoporosis Foundation of South Africa