Bisphosphonates and other drugs affecting bone metabolism
Prescribe for osteoporosis only in line with NICE criteria for primary or secondary prevention
All patients at risk of osteoporosis should be offered lifestyle advice i.e. smoking cessation, avoiding excess alcohol, weight-bearing and resisted exercise and adequate intake of calcium and vitamin D.
Biphosphonates decrease the risk of vertebral fracture. In addition alendronate and risedronate reduce non vertebral fractures.
HRT is no longer considered the first line option for osteoporosis in women over 50 years.
Bisphosphonates reduce the rate of bone turnover in Paget's disease and can produce remission for varying lengths of time. They may also help relieve associated bone pain.
Calcium and vitamin D (Adcal D3/ Calceos) is recommended for all elderly institutionalised women unless contra-indicated as has been shown to be effective in reducing hip fractures in this group of patients. (Section 9.6.4)
All patients who have been receiving corticosteroids at a dose equivalent to 7.5mg/day prednisolone (or more) for 3 months or longer should be assessed. Review dose and duration of treatment. Evidence-based guidelines recommend that men and women over 65 years or with a previous history of fragility fracture should be offered bone protection (bisphosphonates) when starting steroid therapy. In other patients, if steroid therapy is to continue for at least 3 months, then bone densitometry should be considered. A T-score of –1.5 or lower may indicate the need for intervention with a bone sparing agent. Treatment should usually be on specialist advice only.
Ibandronic acid is available as a 150mg monthly preparation in treatment of osteoporosis for those where compliance is a significant problem. It may also be used for bone metastases in breast cancer if initiated by an appropriate specialist. For the latter it is given by IV infusion or as an oral preparation at a dose of 50mg daily.
Biphosphonates may also be given by IV infusion in treatment of osteoporosis and in Paget’s disease in specific circumstances only. Patient selection criteria.
There have been reports of oespophageal cancer in association with bisphosphonate use. The CSM has concluded that evidence is not strong enough to show that oral bisphosphonates increase risk of oesophageal cancer. For full information see MHRA link below.
There have also been reports of osteonecrosis of the jaw (ONJ) associated with bisphosphonate use. The risk appears to be higher for those who have had IV bisphosphonate rather than oral ones. (Please see EMEA link below for more information).
Raloxifene is also an option for use in line with NICE TA 161.
Daily (5mg) or weekly (35mg) for Osteoporosis.
If intolerant or unable to comply with alendronic acid (as per NICE recommendations)
Due to lower incidence of gastric side effects should be used in preference to alendronic acid for those with a history of peptic ulceration.
Also available for treatment of Paget’s disease.
Drugs not recommended for use in the Leicestershire Health Community because of lack of evidence of clinical effectiveness, cost prioritization or concerns over safety.
All new drugs will be black until they have been through the appropriate approval process - then they will appear as a specific entry
Drugs which should be prescribed only by hospital specialists (clinical review by specialist as appropriate and annually as a minimum).
Drugs which would initially be prescribed by a hospital specialist and then by a GP where full agreement to share the care of each specific patient has been reached under a LMSG Shared Care Agreement (SCA). Specific patient monitoring or intervention required.
Drugs suitable to be initiated and prescribed in primary care only after specialist assessment and recommendation. A shared care agreement is not required.
Drugs for which GPs are able to take full responsibility for prescribing and monitoring subject to specified conditions e.g. prescribing in line with agreed LMSG guidance or able to demonstrate suitable competence see comments under individual entries.
Drugs for which GPs would normally take full responsibility for prescribing and monitoring. Drugs included in this list have been specifically considered by LMSG.