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6.6 Drugs affecting bone metabolism

Osteoporosis guidelines link


6.6.1 Calcitonin and parathyroid hormone

Teriparatide injection - specialist use only – secondary prevention of osteoporotic fractures in post-menopausal women (see NICE TA161); use in males for severe osteoporosis (limited to 24 months treatment course) – RED drug (use same NICE criteria as for women) 
Calcitonin injection (restricted to second-line treatment in severe acute hypercalcaemia if poor response to iv bisphosphonates).


6.6.2 Bisphosphonates and other drugs affecting bone metabolism.

(See also calcium supplements Chapter 9)
Alendronic acid 70mg tablets; effervescent tablets (see note) (both once weekly tablets) - preferred oral bisphosphonates in osteoporosis

Denosumab injection - see notes

 i). Prevention of osteoporotic fractures in post menopausal women: AMBER - see shared care guidelines and NICE TA 204. May also be used in men with osteoporosis utilising the same NICE criteria as in women, and those undergoing androgen deprivation therapy for prostate cancer (NICE CG175).

ii). Prevention of skeletal related events in adults with bone metastases from solid tumours: RED - see NICE TA 265

Disodium pamidronate injection
Ibandronic acid Injection
Raloxifene tablets - specialist use only
Risedronate sodium tablets
Sodium clodronate tablets, capsules - specialist use only. Reduces morbidity and mortality in myeloma.
Zoledronic acid injection, IV - see notes.

 

Notes:

Click here for TA464: Bisphosphonates for treating osteoporosis 

1. Alendronate Effervescent tablets are reserved for patients with genuine dysphagia  who might otherwise require the more expensive oral solution or zoledronic acid injection.

2. Bisphosphonates: osteonecrosis of the jaw

The risk of osteonecrosis of the jaw is greater for patients receiving intravenous bisphosphonates for cancer than for patients receiving oral bisphosphonates for osteoporosis or Paget’s disease (for whom the risk seems to be low). Therefore, all patients with cancer should have a dental check-up before bisphosphonate treatment. All other patients who start bisphosphonates should have a dental examination only if they have poor dental status. During treatment, patients should be encouraged to: maintain good oral hygiene; receive routine dental check-ups; and report any oral symptoms such as dental mobility, pain, or swelling.

    Bisphosphonates: osteonecrosis of the external auditory canal: See Drug Safety Update December 2015

    Bisphosphonates: atypical fractures

Atypical femoral fractures have been reported rarely with bisphosphonate therapy, mainly in patients receiving long-term treatment for osteoporosis. See Drug Safety Update June 2011

3. Bisphosphonate holiday

Local guidance recommends evaluating the continued need for a bisphosphonate at 3-5 years, based on an individual’s assessment of risks and benefits. Patients at high risk of osteoporotic fracture should continue therapy with a bisphosphonate. Low risk patients require assessment using FRAX and BMD scan after 5 years to assess appropriateness of continued therapy with a bisphosphonate. Ensure adequate intake of calcium and vitamin D in all patients including those who discontinue bisphosphonates. 

4. Didronel PMO is licensed for treatment and prevention of post-menopausal and corticosteroid induced osteoporosis in men and women. Trials have shown a reduction in fracture rate at vertebral sites only. Bone mineral density is increased at other sites (wrist and hip) with no evidence of lower fracture rate.

5. All oral bisphosphonates are poorly absorbed and must be taken correctly. Alendronate and risedronate  may cause severe oesphagitis unless manufacturer's instructions are followed closely. In ostroporosis, bisphosphonates should be prescribed in combination with calcium and vitamin D unless the clinician is satisfied the patient is obtaining adequate supplies from thier diet.

6. Disodium pamidronate is first line for hypercalcaemia of malignancy with zoledronic acid reserved for refractory cases.

7. Zoledronic acid IV is for use as second-line, for women with post-menopausal osteoporoisis who cannot tolerate oral bisphosphonates or where such therapy is not suitable (e.g. patients with upper GI problems or swallowing difficulties), or for treatment failures. It will be used instead of ibandronate or pamidronate. Zoledronic acid is also used, as per NICE guidance for prevention of skeletal-related events and pain management in patients with advanced breast cancer (i.e. with bone metastases) and for pain relief in men with hormone refracting prostate cancer when other treatments have failed.

8. Zoledronic acid is associated with reports of renal impairment and renal failure, especially in patients with pre-existing renal dysfunction or other risk factors. Renal function should be measured before each dose, and patients should be adequately hydrated before treatment. Renal function monitoring is recommended after use of zoledronic acid in 'at risk' patients, especially those with pre-existing renal impairment. Use in patients with severe renal impairment is generally not recommended, but may be considered for tumour-induced hypercalcaemia, if the benefits outweigh the risks.

9. Raloxifene has recently been introduced for the prevention of vertebral fractures in women at increased risk of osteoporosis (see Derbyshire County Osteoporosis Guidelines). It has no effect on menopausal vasomotor symptoms.

10. Ibandronic acid injection is for 4th line treatment of post menopausal osteoporosis.

11. Denosumab has been associated with cases of severe symptomatic hypocalcaemia, some of which have been fatal. This most commonly occurs within the first 6 months of treatment. Pre-existing hypocalcaemia must be corrected prior to initiation of denosumab. Periodic monitoring of calcium levels is recommended in patients considered to be at risk. See the MHRA Drug Safety Update October 2012.

Denosumab has also been associated with rare reports of atypical femoral fracture with long-term use. Patients should be advised to report new or unusual thigh, hip or groin pain. See MHRA Drug Safety Update February 2013.

Denosumab is also associated with a risk of osteonecrosis of the jaw (ONJ). To reduce the risk a dental examination and appropriate preventative dentistry is now recommended before starting treatment in all patients treated for its cancer indication, and those with risk factors treated for osteoporosis. All patients should be advised to maintain good oral hygiene, and report any oral symptoms of ONJ to their doctor or dentist.

Further advice is given on monitoring for hypocalcaemia

See MHRA Drug Safety Update September 2014  and July 2015 (Patient Reminder cards available)

 

For link to BNF section: 6.6 Drugs affecting bone metabolism