This guidance covers the treatment of postmenopausal women who have normal calcium levels and/or vitamin D levels. Unless clinicians are confident that women who receive osteoporosis treatment have an adequate calcium intake and are vitamin D replete, calcium and/or vitamin D supplementation should be provided.
This guidance does not cover the treatment of corticosteroid-induced osteoporosis.
1.1 Bisphosphonates (alendronate, etidronate and risedronate) are recommended as treatment options for the secondary prevention of osteoporotic fragility fractures: - in women aged 75 years and older, without the need for prior dual energy X-ray absorptiometry (DEXA) scanning - in women aged between 65 and 74 years if the presence of osteoporosis is confirmed by DEXA scanning, and - in postmenopausal women younger than 65 years of age, if they have a very low bone mineral density (BMD, that is with a T-score of approximately .3 SD or below., established by a DEXA scan), or if they have confirmed osteoporosis plus one, or more, additional ageindependent risk factor: low body mass index (< 19 kg/m2); family history of maternal hip fracture before the age of 75 years; untreated premature menopause; certain medical disorders independently associated with bone loss (such as chronic inflammatory bowel disease, rheumatoid arthritis, hyperthyroidism or coeliac disease); conditions associated with prolonged immobility.
1.2 In their choice of bisphosphonate, clinicians and patients need to balance the drugs overall proven effectiveness profile against tolerability and adverse effects in individual patients.
1.3 Raloxifene is recommended as an alternative treatment option, under the circumstances specified in Section 1.1, in women: - for whom bisphosphonates are contraindicated (see Summaries of Product Characteristics), or - who are physically unable to comply with the special recommendations for use of bisphosphonates, or - who have had an unsatisfactory response to bisphosphonates (as defined in Section 1.5), or - who are intolerant of bisphosphonates (as defined in Section 1.6).
1.4 Teriparatide is recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures in women aged 65 years and older who have had an unsatisfactory response to bisphosphonates or intolerance to bisphosphonates (as defined in Sections 1.5 and 1.6, respectively), and: - who have an extremely low BMD (with a T-score of approximately 4 SD or below), or - who have a very low BMD (with a T-score of approximately 3 SD or below) plus multiple fractures (that is, more than two) plus one, or more, additional age-independent risk factor: low body mass index (< 19 kg/m2); family history of maternal hip fracture before the age of 75 years; untreated premature menopause; conditions associated with prolonged immobility.
1.5 For the purpose of this guidance, an unsatisfactory response occurs when woman has another fragility fracture despite adhering fully to treatment for 1 year and there is also evidence of a decline in BMD below her pre-treatment baseline.
1.6 For the purpose of this guidance, intolerance of bisphosphonates is defined as oesophageal ulceration, erosion or stricture, or severe lower gastrointestinal symptoms, any of which warrants discontinuation of treatment with a bisphosphonate.