Recommendations2012 update of French guidelines for the pharmacological treatment of postmenopausal osteoporosis
Section snippets
Objectives and methods
These recommendations are intended for all physicians providing care to postmenopausal women who have osteoporosis or risk factors for osteoporosis. The objective is to discuss the principles of osteoporosis pharmacotherapy based on current data about indications, effectiveness, and safety. The content of these recommendations was discussed and drafted in accordance with the method propounded by the French National Authority for Health (Haute Autorité Sanitaire, HAS) then validated by a
Epidemiology and diagnosis of osteoporosis
Osteoporosis is a generalized bone disease characterized by diminished bone strength with an increased risk of fractures [2]. Osteoporosis is a major health concern, both because of the risk of potentially serious fractures and because its prevalence is increasing as the population ages. The present recommendations are intended only for postmenopausal patients who have none of the other metabolic, malignant, or genetic causes of decreased bone strength.
Evaluation of the fracture risk and treatment decision
The decision to initiate osteoporosis pharmacotherapy rests on the routine evaluation of three variables associated with fracture risk, namely, age, prior fractures, and fall risk, together with BMD values.
Therapeutic strategies for the prevention and treatment of postmenopausal osteoporosis
The treatment objective is to prevent fractures (professional consensus). The decision to initiate treatment rests on the estimated risk of having a fracture within the next 5 to 10 years, which is the duration for which efficacy data are available. Proof that osteoporosis medications prevent fractures was obtained in populations meeting specific BMD criteria or having a history of fractures (Table 4, Table 5, Table 6). When osteoporosis (with or without fractures) is diagnosed, the first step
Theoretical treatment duration
The following factors govern treatment duration (professional consensus):
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patient age;
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bone tissue response to treatment;
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residual treatment effect after drug discontinuation; only low-level evidence is available about fracture rates after drug discontinuation, and studies of surrogate endpoints (BMD and biochemical markers) suggest considerable variability in the residual effect across drugs;
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bone safety and general safety.
Controlled studies have established that the available osteoporosis
Adherence/persistence and safety
As with all drugs for chronic diseases, osteoporosis medications work best when taken as instructed. Several studies have documented decreased efficacy in the event of poor adherence. Clinical follow-up may be sufficient to monitor adherence and persistence (professional consensus). Patients should be informed of the very low risks of jaw osteonecrosis and atypical femoral fracture associated with bisphosphonate therapy. Any necessary dental procedures should be performed at the beginning of
Conclusion
This recommendation update is intended for all physicians providing care to women who have postmenopausal osteoporosis or who are at risk for the disease. Their objective is to review the principles of osteoporosis pharmacotherapy based on current data about the indications, efficacy, and safety of osteoporosis medications.
Literature review task force
Bachelot Anne (Endocrinologue, Paris), Brazier Michel (Pharmacien, Amiens), Benhamou Claude-Laurent (Rhumatologue, Orléans), Berrut Gilles (Gériatre, Nantes), Christin-Maitre Sophie (Endocrinologue, Paris), Cohen-Sohal Martine (Rhumatologue, Paris), Darai Emile (Gynécologue, Paris), Debiais Françoise (Rhumatologue, Poitiers), Drapier Faure Evelyne (Gynécologue, Lyon), Gompel Anne (Endocrinologue, Paris), Javier Rose-Marie (Rhumatologue, Strasbourg), Laroche Michel (Rhumatologue, Toulouse),
Disclosure of interest
Karine Briot: occasional interventions: consultancy or speaker fees from Amgen, Lilly, MSD, Novartis, and Servier. Indirect interests: financial support for research programs or investigator fees from Lilly.
Bernard Cortet: occasional interventions: consultancy or speaker fees from Amgen, Daiichi-Sankyo, Ferring, GSK, Lilly, MSD, Medtronic, Novartis, and Servier. Indirect interests: financial support for research programs or investigator fees from Amgen, Lilly, MSD, Novartis, and Roche.
Thierry
References (73)
- et al.
A reference standard for the description of osteoporosis
Bone
(2008) - et al.
Vertebral fracture assessment: the 2007 ISCD official positions
J Clin Densitom.
(2008) - et al.
Fall-related factors and risk of hip fracture: the EPIDOS prospective study
Lancet.
(1996) - et al.
Use of calcium or calcium in combination with vitamin D supplementation to prevent fractures and bone loss in people aged 50 years and older: a meta-analysis
Lancet
(2007) - et al.
Use of calcium supplementation and the risk of coronary heart disease in 52–62-year-old women: the Kuopio Osteoporosis Risk Factor and Prevention Study
Maturitas.
(2009) - et al.
Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group
Lancet
(1996) Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project
Qual Saf Health Care.
(2003)Osteoporosis prevention, diagnosis, and therapy
JAMA
(2001)- et al.
Mortality risk associated with low-trauma osteoporotic fracture and subsequent fracture in men and women
JAMA
(2009) Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: report of a WHO study group. WHO Technical Report Series no. 843
(1994)
Official position of the International Society for Clinical Densitometry
J Clin Endocrinol Metab
An update on the diagnosis and assessment of osteoporosis with densitometry
Osteoporos Int
International variation in proximal femur bone mineral density
Osteoporos Int
Prevalent vertebral deformities predict hip fractures and new vertebral deformities but not wrist fractures
J Bone Miner Res
Patients with prior fractures have an increased risk of future fractures: a summary of the literature and statistical synthesis
J Bone Miner Res
Clinical subsequent fractures cluster in time after first fractures
Ann Rheum Dis.
Manitoba Bone Density Program. Time since prior fracture is a risk modifier for 10-year osteoporotic fractures
J Bone Miner Res.
Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures
BMJ
Fracture incidence and association with bone mineral density in elderly men and women: the Rotterdam Study
Bone
Identification of osteopenic women at high risk of fracture: the OFELY study
J Bone Miner Res
FRAX® and the assessment of fracture probability in men and women from the UK
Osteoporos Int
A comparison of prediction models for fractures in older women: is more better?
Arch Intern Med.
FRAX and risk of vertebral fractures: the Fracture Intervention Trial
J Bone Miner Res
The FRAX tool in French women: how well does it describe the real incidence of fracture in the OFELY cohort?
J Bone Miner Res.
Fracture risk prediction using BMD and clinical risk factors in early postmenopausal women. Sensitivity of the WHO FRAX tool
J Bone Miner Res.
FRAX® probabilities and risk of major osteoporotic fracture in France
Osteoporos Int.
Closing the gap in postfracture care at the population level: a randomized controlled trial
CMAJ.
Hip protectors for preventing hip fractures in older people
Cochrane Database Syst Rev.
Vascular events in healthy older women receiving calcium supplementation: randomised controlled trial
BMJ
Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis
BMJ
Calcium supplements with or without vitamin D and risk of cardiovascular events: reanalysis of the Women's Health Initiative limited access dataset and meta-analysis
BMJ.
Calcium supplementation and the risks of atherosclerotic vascular disease in older women: results of a 5-year RCT and a 4.5-year follow-up
J Bone Miner Res
La vitamine D chez l’adulte: recommandations du GRIO [In French]
Press Med
Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial
JAMA
Zoledronic acid and clinical fractures and mortality after hip fracture
N Engl J Med
Ten years’ experience with alendronate for osteoporosis in postmenopausal women
N Engl J Med
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